Jehangir Centre for Learning

Core Course Fundamentals

CFM1.01: INTRODUCTION TO CLINICAL RESEARCH

C/O JCDC, JEHANGIR HOSPITAL PREMISES,

32, SASSON ROAD, PUNE-1

TELEPHONE NO.: + 91-20- 67268800

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INTRODUCTION TO CLINICAL RESEARCH

A vast, unwieldy population, a plethora of diseases, and rampant

poverty: this was the picture India presented to the outside world
till a while ago.

But these days the fact that India has the largest pool of patients
suffering from cancer, diabetes and other maladies is leading the
country to an altogether different destination: the global hub of
outsourcing of clinical trials.

Clinical trials are a type of research study that uses human

volunteers to see if certain medications or treatments are safe
and effective. This type of research is an important tool
researchers use to find ways to improve health and offer new
treatment options for a wide variety of health conditions. While
there are many ways in which clinical trial studies are designed,
most are either interventional studies, in which a controlled
environment is used to see if experimental treatments are safe
and effective; or observational, in which natural settings are
used to see how therapies or treatments affect large groups of
people.

Most clinical trial studies are sponsored by pharmaceutical or

biotechnology companies, medical institutions, and foundations.
In some cases, a government agency such as the National
Institutes of Health (NIH) provides funding for the trials. The
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United States Food and Drug Administration (FDA) oversees all

clinical trial studies done in the U.S. It is responsible for
determining if a clinical trial is needed, approves the scope and
goals of the trial, helps select the researchers who will run the
trial, review the results of the clinical trial, and determine if the
new medication or device will be made available to the public.
In India this is done by DCGI.

Who can participate in a clinical trial?

In order for a clinical trial to produce reliable results,

participants in the study must be carefully selected. All clinical
trials have rules and guidelines about who can and cannot
participate. These are called inclusion and exclusion criteria and
involve such factors as age, gender, treatment history, stage of
disease, and other medical conditions. Factors that allow a
person to participate in a clinical trial are called the inclusion
criteria and factors that do not allow a person to participate are
called exclusion criteria. Some trials look for participants who
are healthy and have no previous health conditions while other
studies only want participants with certain illness to participate.
Before a clinical trial can accept any participants, the sponsor of
the study must clearly describe the inclusion and exclusion
criteria.

What are the different types of clinical trials?

There are a variety of types of clinical trials including the

following:

• Treatment trials - test new treatments.

• Prevention trials - look for new ways to keep people healthy or

keep a disease from returning.
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• Diagnostic trials - look for better ways to diagnose a disease.

• Screening trials - look for better ways to detect a disease.

• Quality of life trials - look for better ways to improve the

quality of life of people with chronic illnesses.

Each clinical trial is conducted in four phases. The FDA (DCGI)

must approve each phase before the study can continue.

Phase I: In this phase, a new drug or treatment is tested on a

small group of healthy people to determine safe dosage, study
how the drug works in the body, and see if it has any side
effects. The overall safety of the drug is not known during this
phase.

Phase II: The drug or treatment can now be tested on a larger

group of people to see if it is effective and to further test its
overall safety. Rating scales are developed and used to record
data during this phase.

Phase III: Now the drug or treatment is ready to be tested on

even larger numbers of people. The study will look even more
closely at the drug's effectiveness, if it has any side effects,
overall safety, and how it can improve a person's quality of life.
Most drugs that reach this phase are considered for FDA
approval.

Phase IV: Once given FDA approval, the trial can enter into the
final phase, which involves monitoring the drug after it has been
released to the public. In this phase, researchers look for
additional information such as risks, benefits, and optimal or
additional uses of the drug. In some cases this phase is used to

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test the drug on a sub-group of people (such as patients over a

certain age).

Who are involved in clinical research?

Sponsor: An individual, company, institution, or organization

which takes responsibility for the initiation, management, and/or
financing of a clinical trial.

Sponsor-Investigator: An individual who both initiates and

conducts, alone or with others, a clinical trial, and under whose
immediate direction the investigational product is administered
to, dispensed to, or used by a subject. The term does not include
any person other than an individual (e.g., it does not include a
corporation or an agency). The obligations of a sponsor-
investigator include both those of a sponsor and those of an
investigator.

CRO: A person or an organization (commercial, academic, or

other) contracted by the sponsor to perform one or more of a
sponsor's trial-related duties and functions.

Site: Any public or private entity or agency or medical or dental

facility where clinical trials are conducted.

Investigator: A person responsible for the conduct of the

clinical trial at a trial site. If a trial is conducted by a team of
individuals at a trial site, the investigator is the responsible
leader of the team and may be called the principal investigator.

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Regulatory Authorities: Bodies having the power to regulate.

In the ICH GCP guideline the expression Regulatory Authorities
includes the authorities that review submitted clinical data and
those that conduct inspections. These bodies are sometimes
referred to as competent authorities. (E.g.: Regulatory bodies –
US-FDA (USA), EMEA (Europe), DCGI (India), Ethics
committee, (EC), / Institutional Review Board (IRB), IEC

Institutional Review Board (IRB): An independent body

constituted of medical, scientific, and non-scientific members,
whose responsibility is to ensure the protection of the rights,
safety and well-being of human subjects involved in a trial by,
among other things, reviewing, approving, and providing
continuing review of trial protocol and amendments and of the
methods and material to be used in obtaining and documenting
informed consent of the trial subjects.

Independent Ethics Committee (IEC): An independent body

(a review board or a committee, institutional, regional, national,
or supranational), constituted of medical professionals and non-
medical members, whose responsibility it is to ensure the
protection of the rights, safety and well-being of human subjects
involved in a trial and to provide public assurance of that
protection, by, among other things, reviewing and approving /
providing favorable opinion on, the trial protocol, the suitability
of the investigator(s), facilities, and the methods and material to
be used in obtaining and documenting informed consent of the
trial subjects.

Subjects: An individual who participates in a clinical trial,

either as a recipient of the investigational product(s) or as a
control.

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Institutional Review Board / Independent Ethics Committee

(IRB/IEC):
1. An IRB/IEC should safeguard the rights, safety, and well-
being of all trial subjects.
Special attention should be paid to trials that may include
vulnerable subjects.
2. The IRB/IEC should obtain the following documents:
• trial protocol(s)/amendment(s),
• written informed consent form(s)
• consent form updates that the investigator proposes for use
in the trial,
• subject recruitment procedures (e.g. advertisements),
• written information to be provided to subjects,
• Investigator's Brochure (IB),
• available safety information,
• information about payments and compensation available to
subjects,
• the investigator’s current curriculum vitae and/or other
documentation evidencing qualifications, and
• any other documents that the IRB/IEC may need to fulfill
its responsibilities.
The IRB/IEC should review a proposed clinical trial within a
reasonable time and document its views in writing, clearly
identifying the trial, the documents reviewed and the dates for
the following:
• approval/favorable opinion;
• modifications required prior to its approval/favorable
opinion;
• disapproval / negative opinion; and
• termination/suspension of any prior approval/favorable
opinion.

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3. The IRB/IEC should consider the qualifications of the

investigator for the proposed trial, as documented by a current
curriculum vitae and/or by any other relevant documentation the
IRB/IEC requests.
4. The IRB/IEC should conduct continuing review of each
ongoing trial at intervals appropriate to the degree of risk to
human subjects, but at least once per year.
5. The IRB/IEC may request more information be given to
subjects when, in the judgement of the IRB/IEC, the additional
information would add meaningfully to the protection of the
rights, safety and/or well-being of the subjects.
6. When a non-therapeutic trial is to be carried out with the
consent of the subject’s legally acceptable representative the
IRB/IEC should determine that the proposed protocol and/or
other document(s) adequately addresses relevant ethical
concerns and meets applicable regulatory requirements for such
trials.
7. Where the protocol indicates that prior consent of the trial
subject or the subject’s legally acceptable representative is not
possible, the IRB/IEC should determine that the proposed
protocol and/or other documents.

PRINCIPAL INVESTIGATOR (PI):

The PI will be ultimately and solely responsible for meeting

government regulations and ICH GCP guidelines concerning
clinical research conducted at this site. The PI will perform the
following activities to ensure the proper conduct of clinical
studies:

1. Identify research participants for the study.

2. Ensure patient safety during the conduct of the research
study.
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3. Ensure that the IRB has approved the protocol and all the
study related documents.
4. Ensure that any tasks and responsibilities related to the
study are delegated to qualified personnel only and are
properly documented.
5. Assign trained and dedicated study coordinators to manage
the study where appropriate.
6. Ensure that each study coordinator follow the SOPs and
other standard methods for all clinical research activities to
ensure GCP compliance and data quality.
7. Ensure that the Informed Consent is explained to the
Subject in detail in understandable language and answer
all the queries asked by the subject and document the
Informed Consent process.
8. Ensure that the patient is aware of other treatment options
besides the study and willingly opts for the study.
9. Obtain Informed Consent prior to study procedures.
10. Ensure that the eligibility criteria are met as per the
protocol
11. Ensure that all Serious Adverse Events and sponsor
safety reports are reported to the IRB and the sponsor per
timeline requirements.
12. The investigator should not implement any deviation
from or changes of the protocol without agreement by the
sponsor and prior review and documented approval from
the IRB of an amendment except where necessary to
eliminate an immediate hazard to trial subjects or when
changes involve only logistical or administrative aspects of
the trial.
13. Ensure that he/she explains the protocol and
answers the queries raised by the IRB during the Ethical
Committee meeting when the protocol is discussed and

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reviewed and as and when required by the Ethics

Committee
14. Ensure that only the concomitant therapy authorized
by the protocol is used.
15. Ensure that all paper work is completed accurately,
timely and completely.
16. Ensure that the study events are recorded in the
subject’s research / medical records (Source Documents).
17. Ensure that all Case Report Forms, source
documents, and other study subject information are
completed accurately and accessible for review. Data
found on CRFs must also be supported by source
documents.
18. Evaluate all reports e.g. Lab, scans, ECG, etc. and
mention their significance including acceptance and also
sign and date each report .This can be done by Sub
investigator or medical coordinator in the absence of PI
but later those reports must be counter signed by the PI.
19. Ensure all study activities follow the approved
protocol and are performed correctly.
20. Look into SAE reports and ensure that they are
signed / countersigned.
21. Follow up with AE / SAE till resolution
22. Ensure that the study drug records and storage is
done by the research pharmacist / designated personnel.
23. Maintain adequate records of dispensing, returns, and
/ or destruction of study drug.
24. Ensure that the Regulatory documentation is
organized, complete and available.
25. Maintain all sponsor / CRO, institute and IRB
communications.
26. Patient termination decision for any safety reasons to
be taken by PI only
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27. Sign and date all corrections and countersign all

important events if SI / medical coordinator is writing
source documents.
28. Agree to the SOPs of the institute before undertaking
a study.
29. Interact with sponsors and monitors verbally or on
paper. If communication is verbal, the communication to
be documented in the telephone log.

SPONSOR

1. Quality Assurance and Quality Control

The sponsor is responsible for implementing and
maintaining quality assurance and quality control systems
with written SOPs to ensure that trials are conducted and
data are generated, documented (recorded), and reported in
compliance with the protocol, GCP, and the applicable
regulatory requirement(s).

2. Contract Research Organization (CRO)

A sponsor may transfer any or all of the sponsor's trial-
related duties and functions to a CRO, but the ultimate
responsibility for the quality and integrity of the trial data
always resides with the sponsor. The CRO should
implement quality assurance and quality control.

3. Medical Expertise
The sponsor should designate appropriately qualified
medical personnel who will be readily available to advise
on trial related medical questions or problems. If
necessary, outside consultant(s) may be appointed for this
purpose.

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4. Trial Design
The sponsor should utilize qualified individuals (e.g.
biostatisticians, clinical pharmacologists, and physicians)
as appropriate, throughout all stages of the trial process,
from designing the protocol and CRFs and planning the
analyses to analyzing and preparing interim and final
clinical trial reports.

5. Trial Management, Data Handling, and Record

Keeping
• The sponsor should utilize appropriately qualified
individuals to supervise the overall conduct of the trial, to
handle the data, to verify the data, to conduct the statistical
analyses, and to prepare the trial reports.
• When using electronic trial data handling and/or remote
electronic trial data systems, the sponsor should ensure and
document that the electronic data processing system(s)
conforms to its established requirements for completeness,
accuracy, reliability, and consistent intended performance
(i.e. validation).An SOP fro the same should be
maintained.
• The sponsor should maintain a security system that
prevents unauthorized access to the data.
• An adequate backup of the data should be maintained .
o If the sponsor discontinues the clinical development
of an investigational product, the sponsor should
notify all the trial investigators/institutions and all
the regulatory authorities.
• Any transfer of ownership of the data should be reported
to the appropriate authority(ies), as required by the
applicable regulatory requirement(s).

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• The sponsor specific essential documents should be

retained until at least 2 years after the last approval of a
marketing application in an ICH region and until there are
no pending or contemplated marketing applications in an
ICH region or at least 2 years have elapsed since the
formal discontinuation of clinical development of the
investigational product. These documents should be
retained for a longer period however if required by the
applicable regulatory requirement(s) or if needed by the
sponsor.
• The sponsor should inform the investigator(s)/institution(s)
in writing of the need for record retention and should
notify the investigator(s)/institution(s) in writing when the
trial related records are no longer needed.

6. Investigator Selection
The sponsor is responsible for selecting the
investigator(s)/institution(s). Each investigator should be
qualified by training and experience and should have
adequate resources o properly conduct the trial for which
the investigator is selected. If organization of a
coordinating committee and/or selection of coordinating
investigator(s) are to be utilized in multicentre trials, their
organization and/or selection are the sponsor's
responsibility.

7. Allocation of Responsibilities
Prior to initiating a trial, the sponsor should define,
establish, and allocate all trial-related duties and functions.

8. Compensation to Subjects and Investigators

• If required by the applicable regulatory requirement(s), the
sponsor should
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provide insurance or should indemnify (legal and financial

coverage) the investigator/the institution against claims
arising from the trial, except for claims that arise from
malpractice and/or negligence.
• When trial subjects receive compensation, the method and
manner of compensation should comply with applicable
regulatory requirement(s).

9. Financing
The financial aspects of the trial should be documented in
an agreement between the sponsor and the
investigator/institution.

10. Notification/Submission to Regulatory Authority

(ies)
Before initiating the clinical trial(s), the sponsor (or the
sponsor and the investigator, if required by the applicable
regulatory requirement(s)) should submit any required
application(s) to the appropriate authority(ies) for review,
acceptance, and/or permission (as required by the
applicable regulatory requirement(s)) to begin the trial(s).
Any notification/submission should be dated and contain
sufficient information to identify the protocol.

11. Confirmation of Review by IRB/IEC

The sponsor should obtain from the
investigator/institution:
• Documented IRB/IEC approval/favorable opinion
• If the IRB/IEC conditions its approval/favourable opinion
upon change(s) in any
aspect of the trial, such as modification(s) of the protocol,
written informed consent form and any other written
information to be provided to subjects, and/or other
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procedures, the sponsor should obtain from the

investigator/institution a copy of the modification(s) made
and the date approval/favourable opinion was given by the
IRB/IEC.

12. Information on Investigational Product(s)

When planning trials, the sponsor should ensure that
sufficient safety and efficacy data from nonclinical studies
and/or clinical trials are available to support human
exposure by the route, at the dosages, for the duration, and
in the trial population to be studied. All this information
should be made available in the form of the Investigational
Brochure which should be periodically updated or as
significant information is made available.

13. Manufacturing, Packaging, Labelling, and

Coding Investigational Product(s)
• The sponsor should ensure that the investigational
product(s) (including active comparator(s) and placebo, if
applicable) is characterized as appropriate to the stage of
development of the product(s), is manufactured in
accordance with any applicable GMP, and is coded and
labelled in a manner that protects the blinding, if
applicable.
• In blinded trials, the coding system for the investigational
product(s) should include a mechanism that permits rapid
identification of the product(s) in case of a medical
emergency, but does not permit undetectable breaks of the
blinding.

14. Supplying and Handling Investigational Product(s)

The sponsor is responsible for supplying the
investigator(s)/institution(s) with the
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Investigational product(s).
The sponsor should:
• Ensure timely delivery of investigational product(s) to the
investigator(s).
• Maintain records that document shipment, receipt,
disposition, return, and
destruction of the investigational product(s)
• Maintain a system for retrieving investigational products
and documenting this
retrieval (e.g. for deficient product recall, reclaim after
trial completion, expired
product reclaim).
• Maintain a system for the disposition of unused
investigational product(s) and for
the documentation of this disposition.
• Maintain sufficient quantities of the investigational
product(s) used in the trials to
reconfirm specifications, should this become necessary,
and maintain records of
batch sample analyses and characteristics. To the extent
stability permits, samples
should be retained either until the analyses of the trial data
are complete or as
required by the applicable regulatory requirement(s),
whichever represents the
longer retention period.

15. Record Access

The sponsor should ensure that it is specified in the
protocol or other written agreement that the
investigator(s)/institution(s) provide direct access to source

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data/documents for trial-related monitoring, audits,

IRB/IEC review, and regulatory inspection.

16. Safety Information

• The sponsor is responsible for the ongoing safety
evaluation of the investigational
product(s).
• The sponsor should promptly notify all concerned
investigator(s)/institution(s) and the regulatory
authority(ies) of findings that could affect adversely the
safety of subjects,impact the conduct of the trial, or alter
the IRB/IEC's approval/favourable opinion to continue the
trial.

17. Adverse Drug Reaction Reporting

The sponsor should expedite the reporting to all concerned
investigator(s)/institutions(s), to the IRB(s)/IEC(s), where
required, and to the
regulatory authority(ies) of all adverse drug reactions
(ADRs) that are both serious and unexpected.

18. Monitoring
a) The purposes of trial monitoring are to verify that:
• The rights and well-being of human subjects are protected.
• The reported trial data are accurate, complete, and
verifiable from source
• documents.
• The conduct of the trial is in compliance with the currently
approved protocol/amendment(s), with GCP, and with the
applicable regulatory requirement(s).
b) Selection and Qualifications of Monitors
Monitors should be appointed by the sponsor.

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Monitors should be appropriately trained, and should have

the scientific and/or
clinical knowledge needed to monitor the trial adequately.
c) Extent and Nature of Monitoring
The sponsor should ensure that the trials are adequately
monitored. The sponsor should determine the appropriate
extent and nature of monitoring
d) Monitor's Responsibilities
The monitor(s) in accordance with the sponsorís
requirements should ensure that the trial is conducted and
documented properly in compliance with the
Protocol,Sponsor SOPs,GCP and applicable regulatory
guideline

19. Audit
If or when sponsors perform audits, as part of
implementing quality assurance, they should consider the
following:
• The purpose of a sponsor's audit, which is independent of
and separate from routine monitoring or quality control
functions, should be to evaluate trial conduct and
compliance with the protocol, SOPs, GCP, and the
applicable regulatory requirements.
• The sponsor should appoint individuals, who are
independent of the clinical trials/systems, to conduct
audits.
• The sponsor should ensure that the auditors are qualified
by training and experience to conduct audits properly. An
auditorís qualifications should be
documented.
• The sponsor should ensure that the auditing of clinical
trials/systems is conducted

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in accordance with the sponsor's written procedures on

what to audit, how to audit, the frequency of audits, and
the form and content of audit reports.

20. Clinical Trial/Study Reports:

Whether the trial is completed or prematurely terminated,
the sponsor should ensure that the clinical trial reports are
prepared and provided to the regulatory agency (ies) as
required by the applicable regulatory requirement(s).

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HISTORY
The birth of clinical trials
“Let us take out of the hospitals, out of the camps, or from
elsewhere, 200, or 500 poor people, that have fevers, pleurisies,
etc. Let us divide them into half, let us cast lots that one half of
them may fall to my share, and the other to yours… We shall
see how many funerals both of us shall have.”
Johann Baptista Van
Helmont, 1662

“On the 20th May, 1747, I selected 12 patients in the scurvy, on

board the Salisbury at sea….The most sudden and visible good
effects were perceived from the use of organs and lemons; One
of those who had taken them, being at the end of 6 days fit for
duty.”
Treatise on the Scurvy,
1753

Key milestones:

The Federal Food, Drug, and Cosmetic Act

In the USA in the 1930s, use of “elixir of sulfanilamide”, a
putative antibacterial preparation, led to the deaths of over 100
people. The deaths were a result of the solvent use in the
preparation of the product, which was later found to be toxic.
The tragedy would have been averted if adequate safety testing
had been performed. As a result, on June 25, 1938, President
Roosevelt signed the Federal
Food, Drug and Cosmetic Act, which stated that drug
manufacturers were required to provide scientific proof those
new products, could be safely used before putting them on the
market. This led to requirement for clinical trials.
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The Nuremberg Code

In 1946, public attention was drawn to reports of abuses of
human subjects in biomedical experiments during World War II.
Twenty –three Nazi physicians went on trial at Nuremberg for
crimes committed against prisoners of war, including exposure
of humans to extremes of temperature, performance of
Mutilating surgery, and deliberate infection with a variety of
lethal pathogens. During the trials, the Nuremberg Code was
drafted as a set of standards for judging the physicians and
scientists who had conducted these experiments. It set ten
conditions that must be met to justify research involving human
subjects. The two most important conditions were the need for
voluntary informed consent of subjects and a scientifically valid
research design that could produce fruitful results for the good
of society.

The Kefauver-Harris amendments

The late 1050s witnessed another tragedy-the birth of large
numbers of children with deformities as a result of their mothers
receiving the sedative thalidomide during pregnancy. This led,
in 1962, to the enactment of the Kefauver-Harris amendments to
the Federal Food, Drug, and Cosmetic Act. These changes
mandated that manufacturers prove their drugs were effective
for specific medical purposes, as well as safe, through “adequate
and well-controlled “studies, and included the first requirement
for informed consent in US law. These laws applied
retroactively to all drugs introduce since 1938 Food, Drug, and
Cosmetic Act. Firms were also required to report all adverse
reactions to the Food, Drug, and Administration (FDA) and to

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include complete information (about adverse effects as well as

benefits) for physicians in advertisements.

The Declaration of Helsinki

The World Health Organization (WHO) recognized a need for
guidelines that were broader in scope than the Nuremberg Code
and developed “The Declaration of Helsinki: Recommendations
Guideline Medical Doctors in Biomedical Research involving
Human Subjects”, which were adopted by the World Medical
Association in 1964. These guidelines are continually evolving
and to Date have been amended six times, in 1975,1983, 1989,
1996,2000,and most recently 2001.The Declaration of Helsinki
provides a comprehensive international statement on ethics and
was the basis for the development of the international
Conference on Harmonization Guideline for Good Clinical
Practice(ICH-GCP; see later)

The US Surgeon General Policy statement /45 Code of

Federal Regulations 46
In 1966, the US Surgeon General policy statement stipulated
that all human subject research required independent prior
review, and created the ideas of institutional review boards
(IRBs).
Regulations for the Protection of Human Subjects of Biomedical
and Behavioral Research (45 CFR 46) formalized rib production
in US Law in 1974.

The Belmont Report

Also in the early 1970s came the revelation that, since the 1930s
approximately 400 men in Tuskegee, Alabama, USA had been
involved without their knowledge, in a lengthy study on the
natural history of syphilis (the Tuskegee Syphilis Study). These

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prior written authorization of Jehangir Centre for Learning (JCL).
 c/o JCDC Pvt. Ltd., Jehangir Hosp. Premises, 32, Sassoon Road, Pune-411001. Tel# 020-67268800

men were denied penicillin even after its introduction as the

standard treatment for the disease.
The Senate Committee on Labor and Human Resources held
hearings on this study and on other alleged healthcare abuses of
prisoners and children, which resulted in the formation of the
National Commission for Protection of Human Subjects of
Biomedical and Behavioral Research. This body issued “The
Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research” in 1979. It embodies
the fundamental ethical principles on which current US federal
legislation on clinical research is based.
The report provides guidance for distinguishing therapeutic
medicine from research, and identifies three fundamental ethical
principles for the protection of human subjects that are relevant
to all research involving humans:
Respect- taking into account subjects individuality and their
right to choose.
Beneficence-minimizing harm while maximizing benefits.
Justice-equitable benefits for equitable risks.
Although other important principles sometimes apply to
research, these three provide a comprehensive framework for
ethical decision-making in research involving human subjects.

International Conference on Harmonization Guideline for

Good Clinical Practice
For most countries, the 1960s and 1970s saw a rapid increase in
laws, regulations, and guidelines for reporting and evaluating
the safety, quality and efficiency dated of new medicinal
products. The pharmaceutical industry was also becoming more
international and seeking new global markets, but the
registration of medicines remained a national responsibility.
Harmonization of regulatory requirements was pioneered by the
European Community in the 1980s after it demonstrated that
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prior written authorization of Jehangir Centre for Learning (JCL).
 c/o JCDC Pvt. Ltd., Jehangir Hosp. Premises, 32, Sassoon Road, Pune-411001. Tel# 020-67268800

harmonization within the EC was feasible. At the same time

there were discussions between Europe, Japan and USA on
possibilities for harmonization. Plans were made at the WHO
conference of Drug Regulatory Authorities in 1989, and soon
afterwards, in 1990 the International Conference on
Harmonization (ICH) was established to globally harmonize
every step of drug research and development. The European
Commission, the European Federation of Pharmaceutical
Industries Association, Japan’s Ministry of Health and Welfare
and Pharmaceutical Manufacturer’s Association, the US FDA
and Pharmaceutical Research and Manufacturers of America are
part of the ICH. Observers, who act as a link between the ICH
and non-ICH regions, are Health Canada, the WHO, and the
European Free Trade Association.
ICH-GCP is an international standard for ensuring the ethical
and scientific quality of the design conduct, recording and
reporting of trials in human subjects and was adopted by the
European Union (EU) in 1996, and the USA and Japan in 1997.
It is also being adopted by trail sponsors and researchers in non-
ICH areas, such as sub-Saharan Africa.

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prior written authorization of Jehangir Centre for Learning (JCL).