Clinical trials for children: Some concerns

Abstract

Concerns about the safety of clinical trials for children in India are addressed. It would be reasonable to conduct clinical trial in children if sufficient proof of efficacy and safety has already been generated in adults. It would be prudent to recommend that ideally pediatric trial should be deferred till adult testing has reached Phase III of drug development or beyond. [12] However, the above criteria may be relaxed if the research involves disease that affects children exclusively (genetic or metabolic diseases). Risk minimization strategy should be adopted for all clinical trials involving children. Data safety monitoring committee involving pediatricians should be formed in all institutions where these trials are undertaken. As blinding in trials poses risks, special precautions must be taken for such trials. The informed consent process and conduct of the trial should be done in a clear and transparent manner.