In a decision that will go a long way in boosting the clinical trial industry in the country, the Union health ministry has removed the restriction on the number of clinical trials an investigator can undertake at a time. At present, no investigator should conduct more than three trials at any given period of time. Removing the restriction, the ministry has now empowered the ethics committee to take a final call on the number of clinical trials an investigator can do at any given time after examining the risk and complexity involved in the trials.
Earlier, there were objections from the stakeholders including the clinical trial organisations in the country against the health ministry’s decision to restrict the number of clinical trials an investigator can do at a time as they felt that the restriction was impeding clinical research in the country as this has led to the under-utilisation of the healthcare infrastructure developed over the last one decade on one hand coupled with high attrition rates in the industry.
Experts were of the opinion that 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.
In the light of widespread resentment against the restriction, the Union health ministry convened several meetings with the industry associations and other stakeholders. To deliberate stakeholders concerns and the way forward relating to some issues on conduct of clinical trials in India, two such meetings were held on 20.8.2015 and 6.10.2015 under the chairmanship of secretary, ministry of health in which other experts in the field were also present.
After detailed discussions and deliberations, the ministry decided to do away with the restriction. “As regards restriction that no investigator shall conduct more than three trials at any given period of time, it has been decided to remove this restriction and it is further decided that ethics committee after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can undertake”, Drugs Controller General of India (DCGI) Dr GN Singh, in his order said.