P. Sree Sudha | India Law Journal | 2007
Clinical trials form an integral part of the drug discovery process worldwide. Clinical trials are the set of practices required to certify a new drug molecule as safe and efficacious for the market. Medical research, in general, is a good thing and absolutely necessary to cure number of chronic diseases. At present in India we have 40 million asthmatic patients, about 34 million diabetic patients, 8-10 million people with HIV, 8 million epileptic patients, 3 million cancer patients, more than 2 million cardiac-related deaths, 1.5 million people with Alzheimer’s disease; 15% of the population is hypertensive, and 1% suffers from schizophrenia In order to give best treatment to above diseases research on humans is both necessary and desirable.
A clinical trial is defined as “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.” Interventions include not only drugs but also cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. A set of guidelines are already in place in India for the ethical conduct of studies to safeguard the interests of patients or volunteers participating in the study.
Research subjects’ have long been controversial, even after decades of debate, experience, and Regulation. In this review, this paper aims at discuss the International and National Laws on Clinical Trials, ethics in clinical research, next it reviewed some current controversies on clinical trials and concludes with a discussion we need more standards and Legislations for future medical research on human subjects.