HUMAN

EXPERIMENTATION
WITH DRUGS

• Chemical and drugs are

tested on animal first and
then on humans.

• But it is not sufficient .

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 Why?
An animal may react to a chemical in a way different from the reaction
of a human being. Also, the possible side-effects of a drug are to be
ascertained before it can be allowed to be made available to patients.
A chemical that is safe for animals may produce serious side-effects
when administered to a human being.

Presentation title 2
 Likewise, in vitro studies, that is, studies conducted outside the human
body, as for instance, in a test-tube or a culture-dish, also do not
guarantee that the same effects will occur when that drug or chemical is
actually administered to a patient.

Presentation title 3
 EXPERIMENTATION ON HUMAN IS NECESSARY

1 2 3 4 5
To use a new To conduct To find out To find out the To study the
drug for a medical research whether a drug possible side- optimum
therapeutic to study the effects is safe for effects of a drug dosage of a
purpose. - To of certain drugs on human drug, that is,
find out, for human beings, so consumption. A how much of it
instance, if a that a conclusion drug that is can be given in
drug is effective may be arrived at found to be safe one dose, how
in a particular regarding the in trials on many doses can
efficacy of that
illness, where drug
animals may be given in one
other drugs produce adverse day and how
have failed to effects when long a patient
cure that illness. administered to can continue the
humans. use of that drug.
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 CLINICAL TRIAL

• The Clinical Trials Registry was launched

in India in July, 2007.
• The Registry hopes to bring transparency
to clinical trials in India.
• It also aims to hit out at the current
tendency of publishing the results of a
clinical trial only when such results are
positive.

Presentation title 5
 CLINICAL TRIAL PROCEDURE

1. 2
FULL INFORMED CONCENT
FULL INFORMATION GIVEN
ABOUT THE EXPERIMENT
3
OF ALL THE PARTICIPANTS Attention is to be drawn to
possible alternative.

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4 •The schedules of tests and
.If the clinical study procedures
involves a pregnant •The drugs involved
woman, extra care and •The dosages, or amount of
protective measures are the drug
called for to safeguard the 6
woman and her child.
 Ethics Committee
Several hospital and other medical
institutions now have an Ethics
Committee, which is a body of
individuals appointed to protect the
interests of patients and to address
moral issues. The Committee
generally consists of one Board
Member/Trustee, physicians, social
workers and an administrator.. It is
thus a multi-disciplinary body.
Most Ethics Committees work in an
advisory capacity and often help the
patients to take an informed decision. The
Committee often reviews the policies and
procedures adopted by the institutions,
thus reducing the potential litigation
against the institution. Ethics Committees
are also actively involved in the conduct
and procedures adopted in clinical trials
and the proper publication and
interpretation of their findings.
The Drugs and Cosmetics Rules, 1945,
were revised in 2013 to provide
guidelines relating to formation and
registration of Ethics Committees
 General Rules For human Experimentation .

• . 1) The drug must not be harmful chemical agent

• 2) The must have been tried by other experiments in laboratory or on
animals before using them for human experimentation
• 3) There should be scientific justification for trying them on human
beings
• 4) Once the side effect or harmful effect is noticed, the experiment
should be immediately stopped as soon as the consent is withdrawn
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 5) There should be no monetary gains to the patient
because of the research
6) Experiments should be done only after taking the
informed consent of the patient and/or and should be
stopped as soon as the consent is withdrawn
7) The patient should not be suffering from any other
disease so as to vitiate the result of the research e.g. he
should not have a kidney disease if the drug is excreted
by the kidney

Presentation title 9
 National Ethical Guidelines for Biomedical Research
Involving Children
1.inclusion of Children in Research:
1. It is crucial to include children in clinical research, including clinical trials. By doing so, the benefits of new
therapies can be applied to children promptly.
2. Traditionally, children have often been the last to benefit from medical advancements. However, due to their
inherent vulnerability, potential risks from participating in research studies must be anticipated, and adequate
precautions should be taken.
2.Unique Considerations for Research Involving Children:
1. Research involving children should consider their unique physiology, anatomy, psychology, pharmacology,
social situation, and special needs, as well as those of their families.
2. A child-friendly environment should be maintained during research whenever possible.
3.Risk Assessment:
1. Researchers must assess the benefit and risk of research involving children.
2. Risks should be classified, considering factors such as minimal risk and more than minimal risk.
4.Safety and Efficacy of Drugs:
1. Before testing drugs in children, safety, pharmacokinetics, and initial indications of efficacy should be
established in adults.
2. Drugs should be tested for safety and efficacy in children after initial adult studies.
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THANKYOU.