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Intro-CR

Intro-CR

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06/06/2014

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Introduction to clinical research
What is clinical research?
\ue000Organized research on human beings
Intended to provide adequate information on the drug use as a therapeutic agent on its
safety and efficacy.
\ue000Also referred to as Clinical trial management
Clinical research - position in drug development
Drug development
Discovery research
Formulation and development
Clinical development (trials)
Commercialization
When do we need clinical trials?

\ue001new drugs
\ue001for new uses of existing drugs,
\ue001medical devices,
\ue001new drug delivery systems etc.
\ue001Evidence to prove the efficacy and safety in human beings.
\ue001Only a well designed clinical study on a defined population can give meaningful

results- (positive or negative) about any therapeutic intervention
The need for organized study
\ue001EVALUATION OF DRUG X FOR OSTEOARTHRITIS
\ue001How many patients improved?
-approximately 150 /200
\ue001What was the percentage of improvement?
\ue00180-90%
CLINICAL TRIAL -I
\ue001Any drop outs?
-May be 10-12
\ue001Reasons?
-may be they did not get symptomatic relief???
\ue001Any side effects?
-Gastritis,headache,diarrhoea etc.
CLINICAL TRIAL - II
EVALUATION OF DRUG Y FOR OSTEOARTHRITIS
\ue001How many patients improved?
If the criteria of 40% is considered as improvement, 150/200 showed
improvement(p<.01)
\ue001What was the percentage of improvement?

100 patients 40-50% 40 patients 50-60% 10 patients 60-70%

\ue001Any drop outs?

There were 10 drop outs due to following reasons
3 -gastritis
4- no improvement
3 -reasons not known

\ue001Any side effects?
Gastritis,

headache,
diarrhoea etc.
tingling and numbness

1,2,3, were due to the drug.
OUTCOME
Clinical trial-1

Trial poorly designed No definite outcome, Results ambiguous

Clinical trial \u20132

Trial well designed, organised and conducted
Definite outcome.
Results- conclusive.

Scope of clinical research?
\ue002Total cost of the drug development
900 million US $
\ue002Total time taken for the drug development
10-12 years
\ue0022/3rds of the cost and time is spent on clinical trials.
Historical review-
19TH CENTURY

\ue001Ancient pharmacy practice
\ue001Drugs given on trial and error basis
\ue001Practicing physician decided all.

History: The concept of Ethics
20th CENTURY

\ue001Growth of Pharma industry
\ue0011947 Nuremberg code after the trials by the Nazi physicians
\ue001Emphasized on the informed consent

History: The concept of Ethics
\ue0011950s Proper testing of drugs on human beings started
\ue001The concept of randomised controlled clinical trials appeared.
Historical review: Ethics
Emphasized on the informed consent
WMA (world medical association)-1964-guidance to physicians and other participants in medical
research involving human subjects
Further growth in ethical issues
\ue001WMA (1964) (World Medical Association) guidance to physicians and other
participants in medical research involving human subjects
Declaration of Helsinki
\ue001Thalidomide disaster brought about an exponential growth in Pharmaceutical
legislation
Ethical issues today
\ue001International conference on hormonisation- Good clinical practices
(ICH-GCP) Guidelines
\ue001Institutional review board/Institutional ethics committee
\ue001Patients informed consent
Regulatory guidelines today

\ue001Drugs and cosmetics act 1940
\ue001schedule-Y
\ue001Indian GCP guidelines
\ue001ICMR Guidelines
\ue001WHO Guidelines
\ue001ICH-GCP Guidelines

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