Over 2000 lost life during clinical trials in 4 years

New Delhi: Over 2000 patients, who were part of clinical trials of various drugs in the country, lost their life during 2008-11, office of the Drug Controller General has said. According to data provided by DGCI, Serious Adverse Events of deaths in clinical trials reported during 2008-11 were 2031.

During last four years, 2008-12 (till March 30) the total number of clinical trials registered was 2376, according to Health Ministry data. Most of these trials were spread across number of centres and involved number of patients. The DGCI in response to Indore-based RTI applicant Dr Anand Rai said the Serious Adverse Events of death may occur during clinical trials due to various reasons.

"These could be disease related deaths like cancer etc or administration to critical or terminally-ill patients or side effects or unrelated causes. As per available data, the number of Serious Adverse Events of deaths in clinical trials reported during the last four year viz. 2008, 2009, 2010 and 2011 were 288, 637, 668 and 438 respectively," DGCI said in its RTI response which was pointed out by Information Commissioner Shailesh Gandhi during the hearing of a case at the Central Information Commission.

The DGCI provided details of Serious Adverse Events of deaths in clinical trials but did not give location of these trials which was contested by Rai in his appeal. Gandhi directed the DGCI to provide complete information to Rai and also said collation of data for clinical trials should be done on monthly basis. Acccording to a Lok Sabha reply, the number of clinical trials registered with the Clinical Trials Registry India (CTRI) at Indian Council of Medical Research (ICMR) site during the last three years viz. 2009, 2010 and 2011 and the current year so far is 548, 806, 815 and 207 respectively.