clinical research process ppt

Introduction to Clinical Research

Sep 26, 2014

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Introduction to Clinical Research. Clinical Research Practice 1. This Course Will Introduce You To:. The basics of clinical research, types of clinical trials and why clinical research is necessary.

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• clinical research
• informed consent
• research misconduct
• clinical research trials
• define good clinical practice

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Introduction to Clinical Research Clinical Research Practice 1

This Course Will Introduce You To: • The basics of clinical research, types of clinical trials and why clinical research is necessary. • Good Clinical Practice and Good Laboratory Practice that guide the conduct of clinical research. • The importance of protecting participants and the informed consent procedures. • The overall goals of the current trials. 2

Objectives: • Define clinical research and explain why we perform clinical research. • Define Standard Operating Procedure. • Identify the types of clinical research trials. • Define protocol. • State the protections given to human participants in clinical research. • Define Good Clinical Practice and Good Laboratory Practice. 3

Objectives: • Explain why GCP and training given by the PDP are important to you. • Identify staff that must comply to research ethics and standards. • Explain the importance of “amendments” to a protocol. • Define Case Report Forms and Source documents and their importance in a trial. • Define informed consent and list some of the rules of the process. • State the overall goals of the clinical trial you are working on. 4

What Is Clinical Research? • A scientific research study. • A clinical trial looking for answers to specific questions. • Method for finding safe, new and improved vaccines, drugs, and other treatments to improve health. • Research that relies on human volunteers. 5

So……Clinical Research Is… • Research performed on humans. • Designed to answer specific questions related to human disease, diagnosis, prevention, outcomes and treatments. 6

Why Do We PerformClinical Research? • Test new therapies and drugs. • Gather data from participants who have had a known intervention and monitor results. • Determine the safety and effectiveness of drugs, therapies, and other treatments. • Develop new drugs and treatments that are safer, more effective and faster working than any before. • Ultimately – to improve health status. 7

What Happens In a Clinical Trial? • Human participants are recruited for a particular study based on stated criteria as described in the protocol of the study. 8

Then……. • Participants are fully informed about the trial and give informed consent to participate in the clinical trial. 9

And Only Then…. • A team of doctors, nurses and other research professionals: • check the health of the participant at the beginning of the trial. • give specific instructions for participating in the trial. • monitor the participant carefully during the trial. • collect the relevant data • analyze the data and draw conclusions • report results and share conclusions 10

How Does The Team Ensure Uniformity In Research? Standard Operating Procedures Detailed, written instructions to achieveuniformity of the performance of a specific function. 11

Types of Clinical Research Trials • Treatment trials • Prevention trials • Diagnostic trials • Screening trials • Quality of life trials 12

Types of Clinical Research Trials Treatment trials:Test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. 13

Prevention trials:Look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. May include medicines, vitamins, vaccines, minerals, or lifestyle changes. 14

Diagnostic trials: Are conducted to find better tests or procedures for diagnosing a particular disease or condition. 15

Screening trials:Test better ways to detect a disease or particular health condition. 16

Quality of life trials: Explore ways to improve comfort and the quality of life for individuals with a chronic illness. 17

The Life Cycle Of A Clinical Research Project Write a ResearchProposal Define Research Question (What do you want to know?) Write Protocol Find Funding & Select Research Team Get RegulatoryApproval Conduct Research Analyse Results Report Results 18

Key Parts of the Process • Get Regulatory Approval:Regulatory bodies monitor and approve research. • Institutional Review Board or Ethics Committee (IRB/IEC) • Medicines Control Council (MCC) • South African National Accreditation System (SANAS) • Find Funding:A sponsor, pharmaceutical company, research institution, or other organization funds the project. • Protocol:The study plan. Written procedures detailing the steps to conduct a study, keep participants safe and ensure valid data. 19

Performing Research in South Africa Offers an Unique Environment Significant burden of disease. Hightechnologicalmedical expertise andinfrastructure. SouthAfrica Money, resources and other support for research. Racial-CulturalDiversity 20

Rapid Increase in Research • South Africa has seen a 40% growth in research since 1997. • Could lead to the potential for unscrupulous, unethical and unnecessary conduct of clinical research. RISK 21

Risk of Research MisconductGreatest When Dealing With… • Poor populations. • Low levels of literacy. • Unquestioning acceptance of authority. • Great need for health services. • No knowledge of research. 22

Research Is So “New” …Can You See Why We Need Guidelines? In the light of this growth and unique environments, the need to carefully regulate and guide the conduct of clinical trials becomes urgent and necessary. 23

HowDo We Protect Our Research Participants Against Research Misconduct? • Research principles and guidelines • Research regulations • Informed Consent 24

Principles to Protect Participants GCP GLP Good Clinical Practice Good Laboratory Practice 25

Good Clinical Practice GCP • An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human volunteers. • Simply put …. GCP is the rules by which we conduct our research. 26

Good Laboratory Practice GLP • Represents a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. • Simply put …. GLP is the rules of research in the lab. 27

History of GCP • Nazi Medical War Crimes Nuremberg Code- 1947 29

Declarationof Helsinki (DOH) 1964 Developed by the World Medical Association First significant effort of the medical community to regulate itself. 30

Tuskegee Syphilis Study 1932-1972 Belmont Report 1979 Cornerstone for ethical principles underlying the acceptable conduct of research using human volunteers. 31

Many regulations……needed one standard International Conference on HarmonizationApril 1990 Principles of ICH GCP 32

13 Principles of ICH GCP Two important principles are: • The rights, safety, and well-being of the trial participants are the most important considerations and should prevail over the interest of science and society. • Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). 33

History of GLP • Malpractice – 1970’s • Organization for Economic Co-operation and Development (OECD) 30 Countries-1981 OECD GLP Principles 35

OECD GLP Principles • Regulates the practices of scientists working on the safety testing of prospective drugs. • Imposed by regulatory authorities. • South African National Accreditation System (SANAS) 36

GLP: Fundamental Points • Resources • Rules • Characterization • Documentation • Quality Assurance Photo courtesy of Aeras Global TB Vaccine Foundation. 37

Why Is Following GCP and GLP Important ? Compliance with these standards assures: • participant rights are protected. • the safety of human volunteers. • participant well-being is a priority. • results are used for improvement of health and well-being of all. 38

Why Is Following GCP and GLP Important to You? As part of the research team, each and every one of us is responsible for following ethical guidelines and ensuring valid and credible results. 39

HowDo We Protect Our Research Participants Against Research Misconduct? • Research principles and guidelines • Research regulations • Informed Consent 40

How Is Research Regulated? InstitutionalReview Board or Ethics Committee Data Safety Monitoring Board Research Participant Medicines Control Council SANAS 41

……What If We Need To Change Something ? Remember the Protocol?...... Ask for a protocol amendment…… “A written description of a change(s) to or formal clarification of a protocol.” ( Definition from the ICH Guideline for Good Clinical Practice 1.45) 42

Data Collection Source Data • All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. (ICH 1.51) Source Documents • Original documents, data and records. (ICH 1.52) Case Report Form (CRF) • A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH 1.11) 43

A Few Rules for Completing Study Documentation: • Make sure that you are designated to complete the documents. • Write legibly. • Do not leave any blank fields on documents. • Do not use correctional fluid. • Double check that information is accurate and consistent with the source document. • Make corrections and edits according to GCP guidelines. (ICH 4.9) 44

HowDo We Protect Our Research Participants Against Research Misconduct? • Research regulations • Research principles and guidelines • Informed Consent 45

Informed Consent A process by which a subject voluntarily confirms his or her willingnessto participate in a particular trial, • …after having been informed of all aspects of the trial • …that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. (ICH 1.28) 46

Who Is Responsible For Performing The Informed Consent Procedure? According to the ICH GCP Guidelines 4.8.5.. “The investigator, or a person designated by the investigator, should fully inform the participant/legal representative, of all pertinent aspects of the trial……” 47

The Rules Of The Informed Consent Process ICH GCP GUIDELINES 4.8 (see attached handout) 48

No study procedures are allowed before the informed consentprocess is complete and the informed consent document is signed. 49

? Projects/Trials ? CCS BCG HIV TB HIV Neo-natal PHASE I BCG RCT Adoll. ? OBJECTIVES ? 50

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• Preferences

INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research - PowerPoint PPT Presentation

INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research

Introduction to clinical research lecture 1: who, what, why and where of clinical research richard j. barohn, m.d. professor and chairman department of neurology – powerpoint ppt presentation.

• Richard J. Barohn, M.D.
• Professor and Chairman
• Department of Neurology
• Director, General Clinical Research Center
• University of Kansas Medical School
• August 24, 2006
• Types of clinical research
• Retrospective looking back at data previously collected
• - Case Reports
• - Case Series
• Prospective make plan for future data collection
• - Observational
• - Interventional
• - Device/technique
• Can involve direct participant contact
• - Measure a clinical end-point
• Obtain tissue samples from participant to study in the laboratory
• Can be data-mining of clinical databases
• - Never see participant
• - Example Medicare database
• Survival (mortality)
• Physiologic parameter
• Example quantitative strength, breathing (vital capacity)
• Clinical scales
• Example Mini Mental Status
• Blood or other body tissue measurement
• Example - Glucose Level
• - Hormone Level
• Open-label Trial
• Everyone receives research intervention
• Controlled Trial
• Some receive research intervention, some do not
• Control group - Ones that do not receive research intervention
• Control group can be getting another intervention
• Comparing new drug to older one
• Or control group can get placebo (inactive intervention)
• Randomized Trials
• Participants randomly allocated to active intervention or control group
• Blinded usually double blind
• Doctor and participant do not know which group subject is in
• Gold Standard Randomized Double-Blinded Controlled Trial
• Most proceeded by beneficial results in laboratory models
• All multicenter with other ALS centers
• COX-2 inhibitor (glutamate inhibitor) (MDA)
• Celebrex trial just completed no benefit
• ? improves strength in athletes (NIH)
• Minocycline oral (cell death inhibitor) (NIH)
• Ceftriaxone intravenous (cell death inhibitor) (NIH)
• CoQ10 (antioxidant) (NIH)
• Arimoclomol (increases heat shock protein) (Biotech investigator initiated)
• Celebrex/creatine vs mino/creatine (ALSA)
• Pre-Clinical Animal and In Vitro Lab Studies
• Phase I Safety (normals disease)
• Phase II Preliminary Efficacy Data with
• additional safety
• usually lt 100 patients
• Phase III Pivotal efficacy trial
• Large, often multicenter
• Phase IV - Post-marketing
• In Academic Health Centers
• Faculty MD, DO, PhD are Principal Investigators and Co-Investigators in Schools of Medicine, Nursing, Allied Health
• Trainees (students, residents, fellows) work under Faculty
• Outside of Academic Health Centers
• Private practice health care providers
• Pharmaceutical companies, example Quintiles
• Biomedical device companies
• Investigator
• Clinical Research Coordinators
• (Example nurse, respiratory therapist, RD)
• Clinical Research Evaluator
• Research Assistant
• Biostatistician
• Data Manager
• Research Pharmacy
• If laboratory based
• Lab research personnel (students, post doctorate, technicians)
• Federal Grants
• Example National Institutes of Health
• FDA-Orphan Drug Grant Program
• Foundations
• Example Muscular Dystrophy Association
• Internal-funding at medical center
• Example Research Institute of KUMC
• Private Donations
• Non-Funded Research
• Local Institutional Support
• KUMC Research Institute
• Disease-Related Foundations
• Standard Research Grants
• Career Development Grants
• NIH (NIH.gov)
• Apply to NIH for
• K23 Clinical Research
• K08 Lab/Translational
• R03 Pilot Program
• R21 Developmental/Exploratory
• Institutional Awarded Training Grants
• T32 Training
• K12 Career Development
• VA Career Development Awards
• Merit Grants
• GOAL RO-1 THE BIG ONE
• Food Drug Administration (FDA)
• PI applies to get IND for drug trial
• Local Human Subjects Committee (Institutional Review Board)
• Local HIPPA Compliance Program
• General Clinical Research Center
• Research Subject Advocate
• Safety Monitors
• Data Safety Monitoring Boards
• Local KUMC DSMB
• National NIH DSMB
• Research Institute Clinical Trials Office
• Serve as centralized sponsor contact point for KUMC
• Prepares consent with PI input
• Prepares and negotiates trial budgets
• Submits protocol/consent to HSC if there is a sponsor
• Contact Laurie Kemble at 588-1242 or http//www2.kumc.edu/researchinstitute/
• Human Subjects Committee
• KUMCs Institutional Review Board
• Committed to ethical, legal and safe conduct in all research involving human participants
• Meets 2nd and 4th Tuesdays
• Submissions by noon Friday, 7 business days prior to meeting
• Submission of materials
• Contact Karen Blackwell at 588-0942 or http//www.kumc.edu/hipaa/
• Focus on steering mechanism not the
• drive train or brakes, as they are
• not usually accessible to mentors.
• The mentor should
• Be interested
• Have experience
• Be available
• Limit number of mentees
• Commit substantial time
• Be vigilant but not intrusive
• In academic health centers
• Departmental clinical space
• Designated research space
• Example GCRC
• Hoglund Brian Imaging Center
• Veterans Administration Medical Centers
• Hospitals not affiliated with AHC
• NIH in Bethesda intramural
• Private health care provider offices
• Industry offices
• Advance science/improve knowledge
• Obtain access to a potential Rx at the earliest possible time
• Current Rx not working
• It helps maintain hope - better than not doing anything
• Desire to meet and speak with researchers
• To help others
• Reimbursement to subject/patient
• Painful unpleasant procedures
• Fear of going off current medication
• New treatment may not be better
• Time commitment/travel
• Side effects
• Fear of the unknown
• Fear of being assigned to placebo
• They accept the disease is their fate
• Efforts futile
• Privacy concerns publication, etc.
• Resentment of medical personnel
• Distrust of science community
• Dont want to be a guinea pig
• Dont agree with focus of research
• Long wait to get research results
• Be considered a partner in the research
• Be treated with respect / taken seriously, kept informed and up-to-date
• Do not want to be talked down to
• Full disclosure of side effects
• Option to stop involvement in study
• Support from research team - availability
• After study, want to know results and if they were on drug or placebo
• Realistic idea when results will be available
• No cost to participant
• Confidentiality
• Enough time and comfortable area
• To ask questions
• In which to do the study
• A NIH-supported multidisciplinary research unit which facilitates investigator-initiated clinical studies and trials conducted by full-time faculty of the AHC.
• Provides clinical research infrastructure to investigators who receive funding from federal agencies, private foundations, other peer-reviewed sources.
• Also, can include investigator initiated unfunded pilot studies and industry sponsored studies.
• This is at no cost to the PIs for Investigator-Initiated Trials
• Provide clinical investigators from the SOM, SON, and SOAH with a modern, state-of-the-art facility in which clinical research could be conducted
• Enhance multidisciplinary research across departments and the three schools
• Enable and train junior faculty and trainees to become more involved in clinical research
• Apply for federal funding to support the GCRC
• Outpatient Unit
• Inpatient Unit
• Scatter Beds
• Metabolic Kitchen
• Informatics Core
• VOTING MEMBERS
• Matthew Mayo, PhD
• Jared Grantham, MD
• Marge Bott, RN, PhD
• Richard McCallum, MD
• Stephen Williamson, MD
• Richard Dubinsky, MD
• Barbara Lukert, MD
• Kevin Latinis, MD, PhD
• Debra Sullivan, PhD, RD, LD
• Patrick Moriarty, MD
• Jo Ann Harris, MD
• John Ferraro, PhD
• Andrea Charbonneau, MD
• Kathryn Ellerbeck, MD
• Ossama Tawfik, PhD, MD
• Barbara Quaney, PT, PhD
• Kathleen Gustafson, PhD
• NON-VOTING EX OFFICIO MEMBERS
• Barbara Atkinson, MD Executive Dean SOM
• Richard J. Barohn, MD Program Director
• Curt Hagedorn, MD Associate Director
• Jeff Burns, MD Assistant Director
• Patricia Kluding, PT, PhD Assistant Director
• Paul Terranova, PhD
• Susan Schmitz, BA, CCRC Administrative Director
• Judy Otey, RN, BSN Nurse Manager
• Ed Ellerbeck, MD, MPH
• Jon Jackson
• Jo Denton, MSN
• Laurie Kemble, BS, CRT
• For GAC approved studies
• Space to see patients
• Biostat support study design
• Data management
• Nurse support
• Administrative support
• Specimen collection/storage
• Common equipment
• No cost for above services to PIs on investigator initiated studies
• Industry sponsored with charges for space/resources
• Space/resources for industry studies
• Permanent space for research coordinators
• Overnight stay on GCRC unit
• GCRC Planning Committee formed 2002
• Construction/Remodeling began June 1, 2004
• Completed October 2004
• 6, 000 square feet in Delp
• Announce GAC will accept research applications from investigators, September 2004
• Began doing studies on GCRC January 2005
• Approval of 53 on-going studies by GAC as of June 2006
• GCRC NIH grant submitted June 1, 2006
• 2 million (direct costs) per year for 3 years
• Contact Judy Otey, RN, BSN
• GCRC Administrative Director
• 913-588-0984 alt. 2460
• jotey_at_kumc.edu
• Nicole Ladesich, BS
• GCRC Senior Coordinator
• 913-588-0976 alt. 2294
• nladesich_at_kumc.edu
• Visit Website http//gcrc.kumc.edu
• Recruiting and retaining researchers
• Explosion in clinical demands, reduced financial margins ? limit time, diluted value
• Regulatory burden
• Fragmented training
• Complexity of training
• No real HOME for clinical researchers
• Limitations / barriers due to NIH funding mechanisms, review, program structures
• Clinical Research covers all studies of diseases and trials of
• treatments in human subjects
• Translational Research describes the steps between a
• fundamental discovery and its application in clinical
• medicine. For example
• Testing a new anti-cancer drug in humans for the first time
• Identifying best practices in the diagnosis, prevention, or management of a disease and enhancing their adoption by the community
• Purpose Forge a transformative and integrative academic home for clinical and translational science
• The home must be a Center, Department, or Institute.
• Encompass all components of clinical research (education, career development, clinical research infrastructure)
• Promote multidisciplinary research teams
• Create an incubator for innovative research tools
• Catalyze the application of new knowledge to clinical practice
• Degree granting capabilities in Clinical Research
• Masters and/or PhD
• No current GCRC funding
• Current K12 applicability?
• Small pool of clinical mentors, current clinical R01s
• Limited culture for CR
• GCRC infrastructure
• Institutional support
• Research Institute
• SOM / SON / SOAH
• Bioinformatics Center (Mayo)
• K-BRIN (Hunt)
• KU Lawrence (Georg and others)
• Intro to CR Course
• K30 (MSCR program)
• KU Lawrence
• Life Span Institute
• Drug Development
• Introduction to CR Course
• No Clinical T32
• Letter of Intent February 27, 2006
• Grant Application March 27, 2006
• Planning grant 150,000 for 1 year
• Full CTSA up to 6 million with pediatrics
• 4 million without pediatrics
• Existing K30, T32, and GCRC are in addition
• 5 year award RFA offered annually
• Goal 60 CTSAs to be awarded by 2012
• Will replace all GCRCs and NCRR / Roadmap K12s
• Planning Steering Committee
• Barbara Atkinson, MD
• Richard J. Barohn, MD
• Governance Planning Sub-Committee
• Grant Writing Planning Sub-Committee
• Lauren Aaronson, PhD, RN
• Education Planning Committee
• Chair Ed Ellerbeck, MD, MPH
• Clinical Research Resources Planning Committee
• Regulatory Planning Committee
• Jim Voogt, PhD
• John Finley, JD, MPH
• Novel Methods Translational Technologies Planning Committee
• Curt Hagedorn, MD
• Health Disparities Research Planning Committee
• Patricia Thomas, MD
• Kirby Randolph, PhD
• Community Participant Planning Committee
• Joshua Freeman, MD

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Step 3: Clinical Research

While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.

On this page you will find information on:

Designing Clinical Trials

Clinical Research Phase Studies

The Investigational New Drug Process

Asking for FDA Assistance

FDA IND Review Team

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol , that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:

Who qualifies to participate (selection criteria)

How many people will be part of the study

How long the study will last

Whether there will be a control group and other ways to limit research bias

How the drug will be given to patients and at what dosage

What assessments will be conducted, when, and what data will be collected

How the data will be reviewed and analyzed

Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

What are the Clinical Trial Phases?

Watch this video to learn about the three phases of clinical trials.

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Purpose: Safety and dosage

During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer.

Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are.

As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. This is important to the design of Phase 2 studies.

Approximately 70% of drugs move to the next phase

Study Participants: Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

Purpose: Efficacy and side effects

In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial.

Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.

Approximately 33% of drugs move to the next phase

Study Participants: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.

Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects

Approximately 25-30% of drugs move to the next phase

Study Participants: Several thousand volunteers who have the disease/condition

Purpose: Safety and efficacy

Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring

Learn more about Clinical Trials .

Drug developers, or sponsors , must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.

In the IND application, developers must include:

Animal study data and toxicity (side effects that cause great harm) data

Manufacturing information

Clinical protocols (study plans) for studies to be conducted

Data from any prior human research

Information about the investigator

Drug developers are free to ask for help from FDA at any point in the drug development process, including:

Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research

After Phase 2, to obtain guidance on the design of large Phase 3 studies

Any time during the process, to obtain an assessment of the IND application

Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.

The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.

Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.

Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.

Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.

Pharmacologist: Reviews preclinical studies.

Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.

Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.

Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

Approval to begin clinical trials.

Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:

Participants are exposed to unreasonable or significant risk.

Investigators are not qualified.

Materials for the volunteer participants are misleading.

The IND application does not include enough information about the trial’s risks.

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.

The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.

This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

Masks Strongly Recommended but Not Required in Maryland

Respiratory viruses continue to circulate in Maryland, so masking remains strongly recommended when you visit Johns Hopkins Medicine clinical locations in Maryland. To protect your loved one, please do not visit if you are sick or have a COVID-19 positive test result. Get more resources on masking and COVID-19 precautions .

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Understanding Clinical Trials

Clinical research: what is it.

Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

Video Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

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