The document provides an overview of clinical trials, detailing their phases, importance, and objectives in evaluating medical interventions. It outlines the phases from initial studies on healthy volunteers to extensive trials on patient populations, highlighting the increasing complexity and rigor of each phase. The text concludes that clinical trials are essential for understanding drug safety and efficacy, with references to foundational literature on the topic.

1. Clinical Trials
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Enrollment No. :- T1621PCE016
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy

2. CONTENT :-
 Introduction to Clinical trials
 Importance of Clinical Trials
 Phase-I of Clinical Trials
 Phase-II of Clinical Trials
 Phase-III of Clinical Trials
 Phase-IV of Clinical Trials
 Conclusion
 References

3. Clinical Trials :-
Clinical trials are research studies performed in people
that are aimed at evaluating a medical, surgical, or
behavioral intervention. They are the primary way that
researchers find out if a new treatment, like a new drug
or diet or medical device is safe and effective in people.
Often a clinical trial is used to learn if a new treatment
is more effective and/or has less harmful side
effects than the standard treatment.
They are conducted only after they have received
health authority/ethics committee approval in the
country where approval of the therapy is sought.

4. Importance of clinical trials :-
Clinical trial helps in getting details about :-
 Drug input
 Pharmacokinetics
 Pharmacodynamics
 Pharmacogenetics
 Pharmacogenomics
 Factors affecting Drug response and finally
 The toxicity and side effects

5. Phase I clinical trial :- (By clinical Pharmacologist )
Objectives :-
To assess safe & tolerated dose
To see if pharmacokinetics differ much from animal to man
To see if kinetics show proper absorption, bioavailability
To detect effects unrelated to the expected action
To detect any predictable toxicity
Inclusion criteria :-
Healthy volunteers - Uniformity of subjects: age, sex, nutritional
status [Informed consent a must]
Exception - Patients only for toxic drugs E.g. AntiHIV, Anticancer
Exclusion criteria :-
Women of child bearing age, children,

6. Phase II clinical trial :- (By clinical Pharmacologist )
 First in patient [ different from healthy volunteer]
 Early phase [20 – 200 patients with relevant disease] :-
-- Therapeutic benefits & ADRs evaluated.
-- Establish a dose range to be used in late phase.
-- Single blind [Only patient knows] comparison with
standard drug.
 Late phase [ 50 – 500] :-
-- Double blind.
-- Compared with a placebo or standard drug.
 Outcomes :-
-- Assesses efficacy against a defined therapeutic endpoint
-- Detailed pharmacokinetic & Pharmacodynamics data
-- Establishes a dose & a dosage form for future trials
 Takes 6 months to 2 years [ 35% success rate]

7. Phase III clinical trial :- (By clinical Investigators)
 Large scale, Randomized, Controlled trials
 Target population: 250 – 1000 patients
 Performed by Clinicians in the hospital
 Minimizes errors of phases I and II
 Methods :-
– Metacentric - Ensures geographic & ethnic variations
– Diff patient subgroups E.g. pediatric, geriatric, renal
impaired
– Randomized allocation of test drug /placebo / standard drug
– Double blinded
– Cross over design
– Vigilant recording of all adverse drug reactions
– Rigorous statistical evaluation of all clinical data
 Takes a long time: up to 5 years [25% success]

8. Phase IV or Post marketing Surveillance :-
(Post marketing Surveillance by Practicing Clinicians)
 No fixed duration / patient population
 Starts immediately after marketing
 Report all ADRs
 Helps to detect
– Rare ADRs
– Drug interactions
– Also new uses for drugs
[Sometimes called Phase V]

10. Conclusion :-
 Clinical trial is the scientific study of drugs in man.
 Based on the results obtained from the animal experiments,
the mechanism of action, potential therapeutic application,
approximate dose range and possible toxicities are first
established for a compound under investigations.
 These results are then translated in the humans in a cautious
manner that form the basis of clinical pharmacology which
deals with Drug input, Pharmacokinetics,
Pharmacodynamics, Pharmacogenetics, Pharmacogenomics,
Factors affecting Drug response.
 Toxicity and side effects.

11. References :-
 M.N. Gosh, (2008) Fundamentals of Experimental
Pharmacology,4th Edition, Hilton and Company, Kolkata.
 S.K. Kulkarni, (2012) Handbook of Experimental
Pharmacology, 4th Edition, Vallabh Prakashan, Delhi.
 Breckenridge, A.M. (1980) Br. Med. J. 280,1303.
 Greenwood, D.T. and Todd, A.H.(1977) In Clinical
Trials.Johnson, F.N. and Johnson, S.Blackwell Scientific
Publications, Oxfords.
 Guidelines for Clinical Trials on Pharmaceutical
Products in India(2201) Published by the Ministry of
health and Family Welfare, Government of India, New
Delhi.
 Melmon, K.L. and Morrelli, H.F.(1978) Clinical
Pharmacology: Basic Principles in Therapeutics, 2nd
Edition, Macmillan Publishing Company Inc. N.Y.