Clinical Trials

Clinical Trials

Subject – Science and Tech

Context – India’s indigenously-developed mRNA vaccine has received regulatory nod for Phase II and III clinical trials.

Concept –

• A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.
• It is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.

Phases of Clinical Trials

• Clinical trials are carried out in four phases. Clinical trials of drugs developed in India have to undergo all four phases of trials in India.
• Phase I or clinical pharmacology trials or “first in man” study: This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
• Phase II or exploratory trials: During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centers to determine its effect and also to check for any unacceptable side effects.
• Phase III or confirmatory trials: Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. In this phase, the group is between 1000-3000 subjects. If the results are favorable, the data is presented to the licensing authorities for a commercial license to market the drug for use by the patient population for the specified and approved indication.
• Phase IV trials or post-marketing phase: Phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Regulatory Mechanism in India

• Clinical trials in India are governed by the acts:
  • Drugs and Cosmetics Act, 1940,
  • Medical Council of India Act, 1956 and
  • Central Council for Indian Medicine Act, 1970.
• Prerequisites of conducting a clinical trial in India are:
  • Permission from the Drugs Controller General, India (DCGI)
  • Approval from respective Ethics Committee where the study is planned
  • Mandatory registration on the ICMR maintained website.