In order to enhance investigator led clinical research for diseases that immensely impact Indian population, the Indian Society of Clinical Research (ISCR) has urged the Union health ministry to empower the institutional ethics committee (IEC) based in hospitals to take the onus of deciding the number of studies/trials an investigator can undertake.

Currently, the Indian regulator has restricted the number of studies/trials to be undertaken by an investigator to only three with another contentious clause stating the size of the hospital to be a 50-bed hospital.

This, according to the recommendation of the ISCR, should be based on the competency/capability of the investigator, requirement of the trial/study and infrastructure of the hospital. There is an urgent need, according to clinical research experts, to amend contentious clauses like putting a cap on trials per investigator and that clinical research is mandated only to be performed in a 50-bed hospital.

Says Suneela Thatte, president, ISCR, "Studies conducted for vaccines may require 10,000 trial subjects whereas studies on cancer may require 60 to 70 trial subjects. Therefore, restricting the number of studies for an investigator is not justified in the interest of clinical research. Institutional ethics committee should be given the power to govern the number of studies an investigator can undertake based on requirement of a particular study because in each therapeutic area the study requirement varies immensely."

According to clinical research experts, this is also in line with the Prof. Ranjit Roy Chaudhury Committee recommendations to ensure better clinical outcomes. Experts also argue that in order to ensure that better clinical research prevails in the country as per the ethical guidelines as laid down in Good Clinical Practices (GCP), investigators who are well versed in clinical practice should also acquire skills of documentation, presentation, management and forecasting of the study to usher in clinical research to address unmet medical needs of the Indian population.

Clinical research is essential not just for developing medicines for emerging health concerns like antibiotic resistant pathogens, H1N1 and dengue but also to find safer medicines for endemic diseases such as malaria, tuberculosis and lifestyle diseases such as diabetes and cardiac disorders.