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1. IMPORTANCE OF CLINICAL
TRIALS IN DRUG DISCOVERY.
 Presentation by : Miss. Karuna Vilas Mane
Miss. Rupali Chanbassappa Khairate
 Institution name : D. S. T. S.’s Mandal college of pharmacy, solapur.
 Class : Final year B pharmacy solapur.
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2. Contents
 Drug development process
 What is clinical trials ?
 Phases of clinical trials
 Importance of clinical trials in drug development process
 Why we need clinical trials ?
 Application of clinical trials
 Overview of clinical trials
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3. Drug development process
Drug
development
Drug
discovery
Target
selection.
In vitro
studies
Preclinical
research
Clinical
trials .
FDA
review
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4. What is clinical trials ?
 The WHO’s definition of a clinical trial is “Any research study that prospectively
assigns human participants or groups of humans to one or more health –related
interventions to evaluate the effects on health outcomes.
 That means people are invited to take part in study in which they receive the new
interventions, and are followed over time to determine whether it works.
 Pre –clinical studies are required before any clinical trials in humans can be started.
Data are collected regarding feasibility and safety of proceeding to animal testing .
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5. Phases of clinical trials
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Phase I
•It target to study on safety, tolerability, and to detect any potential dangerous effect on vital functions.
• Human pharmacology .
•Total 20-80 subjects involved.
Phase II
•Therapeutic exploration and dose ranging.
•The aim is establishment of therapeutic efficacy, dose range and ceiling effect in a controlled setting.
•Total 100-500 patients involved .
Phase III
•Therapeutic confirmation .
•Measure effectiveness and monitor side effects .
•Total 500-3000 subjects involved.
Phase IV
•Post marketing surveillance
•Target on efficacy, acceptability, and adverse effect of drug in the real field situation.

6. Importance of clinical trials in drug
discovery process
 Clinical trials translate results of basic scientific research into better ways to prevent,
diagnose or treat disease.
 The more people take part, the faster we can :
- answer critical research questions
- find better treatments and ways to prevent disease
 Clinical trials can show researchers what does and doesn’t work in humans that cannot
be learned in the laboratory or in animals.
 Clinical trials are the only a small part of research that’s goes into developing new
treatment.
 The whole of process of clinical trials took 10-13 years for completion.
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7. Why we need clinical trials ?
Clinical trials allow us to test whether a new interventions :
 Is effective or safe
 Works properly in the clinical setting
 Works better with one group of people than other
 Is acceptable to a larger proportion of patient , than the existing interventions
 Clinical trials are essential to the developmental of new interventions that help
people to live longer and with less pain or disability.
 They help us to evaluate new drug ,therapies ,devices, interventions ,systems ,
methods and tests .
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8. Applications of clinical trials
 Clinical trials can be used to test :
 Experimental drugs
 Medical devices
 Surgical and other medical treatments and procedures
 Diagnostic or screening tests
 Psychotherapeutic and behavioural therapies
 Health service changes
 Cells and other biological product
 Vaccines
 Dietary changes
 Preventive care strategies
 Educational interventions.
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9. Overview of clinical trials
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10. REFERENCES
 WWW.researchgate.net
 Essentials of medical pharmacology by K. D. Tripathi, 8th edition, jaypee
publications, page no. 87 to 91.
 Basic Principles of drug discovery and drug development, by Benjamin Blass, 1st
edition, page no 108 to 112.
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