Updated on 16 July 2012
CRO industry experts sought better regulations and balanced media coverage for clinical trials
New Delhi: At a media workshop on the clinical research industry (CRO) held at Delhi on July 13, 2012, industry experts urged the media to report in a balanced way. The workshop attended by the journalists from mainstream media, were briefed by the industry on its functioning and related issues. Organized by the Indian Society for Clinical Research (ISCR), an association of clinical research professionals, and Quintiles India, it included the sessions focused on patient safety, patient rights and the importance and need for clinical research for drug development in India.
Putting forth their views on behalf of the industry were Dr Krathish Bopanna, president, Indian Society for Clinical Research; Dr Arun D Bhatt, executive committee member, Indian Society for Clinical Research, Dr Shoibal Mukherjee, chief medical officer, Quintiles and Dr Shamsher Divedi, VIMHANS.
Dr Shoibal Mukherjee highlighted various misconceptions about the overall trial deaths. Dr Mukherjee explained, "The negative event monitoring includes the non-serious event as well. That is apart from serious events where data is sent to Drug Controller General of India (DGCI) in 14 days.
Parliamentary committee has confirmed that the drug related death cannot be necessarily confirmed at the end of the trials." He also pointed towards the fact that there are five times more recruitment by the non-pharma sponsors as compared to pharmaceutical companies. These include NGOs and global funding agencies involved in huge trials.
Dr Mukherjee found the use of term "illegal trials" as misleading. He said, "It is not right to call a trial illegal technically. The reason is that most of the times only a site or two in one particular location might have issues, but that in no way can be that clinical trial conducted a global scale can be termed illegal."