Clinical trial data disclosure set to be more transparent

Drug clinical trials conducted in the country would soon be more transparent, as apex medicine regulator, Drugs Controller General of India (DCGI), is planning to make public disclosure of more trial details mandatory.

Currently, pharmaceutical companies and contract research organisations engaged in clinical research are required to just register their approved trials on a dedicated website maintained by the Indian Council of Medical Research. If the DCGI plans materialise, the companies would have to provide the details of the status of the clinical trials, which include the number of human volunteers that are participating, the locations, details of adverse drug reactions happened during the trials and compensations paid, if any.

The decision to make exhaustive clinical trial information available to the general public through online disclosure is expected to curb the rising complaints against the opaque nature of several such trials that are taking place in India.

According to health ministry officials, over 1,800 clinical trials have so far been registered on the clinical trial registry website.

“When we made registration of all new clinical trials mandatory few months ago, the companies were required to just provide the basic details. Now, we are seeking information that can help us understand the status of each trial, state wise, investigator wise and study the reports of all serious adverse events”, a senior official said.

According to the official, it would also expose investigators (medical doctors) who are undertaking unreasonably high number of clinical trials at the same time.

The office of the DCGI is also examining a proposal to make a similar reporting structure mandatory for bioavailability and bioequivalence studies that are conducted by pharmaceutical companies to prove that the low cost generic version they manufacture is as good as the original molecule. According to officials over 600 bioequivalence and bioavailability studies are taking place in the country every year.