Phase III trial

-D.SAIKRISHNA

Defination
Usually the third and final stage of testing a new drug in human beings Primary assessment of efficacy and safety Randomized or controlled trials

Introduction
Multicentric usually multinational The benefits of multicenter trials include Larger number of participants Different geographic locations Possibility if inclusion of a wider range of population groups Ability to compare results among center Increases the generalizability of the study

Multicenter studies
In many cases, efficacy will vary significantly between population groups with different genetics, environment and ethenic or cultural backgrounds(demographic factor); normally only geographic dispersed trials can properly evaluate this

Objective
Demonstration or confirmation of therapeutic benefits Studies in Phase III are designed to confirm the preliminary evidence accumulated in Phase II that a drug is safe and effective for the use of intended population Intended to provide an adequate basis for marketing approval

Objective
Further explore the dose response relationship (relationship among dose, drug concentration in blood and clinical response) Se of drug in wider populations in different stages of disease Safety and efficacy of the drug in combination with other drugs

Objectives
For drugs intended to be administered for longer periods, trials involving extended exposure to the drugs are ordinarily conducted in Phase III, although they may be initiated in Phase II. Theses studies carried out in Phase III complete the information needed to support adequate instructions for use of drugs

Objectives
For new drugs outside India, Phase III studies needs to be carried out primarily to generate evidence of efficacy and safety of the drug in Indian patients when used as recommended in the prescribing information

 Prior to conduct of Phase III studies in Indian subjects, Licensing authorities may require pharmacokinetic studies to be undertaken to verify that the data generated in Indian population is in conformity with the data already generated abroad.

 If the application is for the conduct of clinical trials as a part of multinational clinical development of the drug, the number of sites and patients as well as the justification for undertaking such trials in India should be provided to the Licensing Authorities along with the application

 Randomized controlled trials Multinational center Larger sample size (300-3000) Aim: Assessment of how effective the drug is in comparison with current gold standard treatment

 Because of their size and comapratively longer duration, Phase III trials are the most expensive, time consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.

 It is a common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency: This allows patients to continue to receive possibly life saving drugs until the drug can be obtained by purchase

 lable expansion Additional safety data Support marketing claims for the drugs

 Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into larger document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details and shelf life

Challenges
Qualified investigators and centers Multinational multi-center trial Cost Regulatory audits Sample size Protocols with aims and objectives Post marketing challenges

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