Positive future for Clinical Research in India
Public interest litigations filed against many clinical trials conducted in India tarnished the image of this research to a large extent. Many trials were stopped and principal investigators grounded. Supreme Court directive to reframe the rules to provide improved protection to trial participants brought another twist in this realm. The new regulations had profound influence on the number of trials being conducted in India. Many global trials were terminated, while many global sponsors pulled out of the India. The number of trials being conducted in India plummeted. The industry became less attractive, unpredictable, and ambiguous, and lost many new contracts and jobs.
Efforts are on to improve the conditions and to avoid mistakes occurred earlier. To start with, training of the ground staff on different aspects of trial that help to avert mishaps and to improve the quality of a study is already under way. Good clinical practice (GCP) training of investigators and certification of Ethics Committee (EC) are significant efforts in the right direction. Compensation issues, a major dilemma for many investigators, particularly those studying incurable or terminally ill diseases, are solved by Institutional Review Board and the investigator. Insurance cover for the participant is also a favorable solution for this issue. Increased awareness about the need of clinical trials to control diseases and to improve health of the citizens are also positive signs, as more and more people will volunteer for the trial. Stakeholders are watchful of the mistakes of past. Sponsors, on the other hand, are now more sensitive to the needs, including training and education for the professionals. Together, the conditions are becoming more conducive for the conduct of clinical trials in the country. It goes without saying that human protection is one of the most important aspect of the trial and once we achieve this, the country will soon be a leading center for conduct of clinical trials.