AIIMS forms panel to probe infants’ deaths in clinical trialsAugust 19th, 2008 - 10:26 pm ICT by IANS
New Delhi, Aug 19 (IANS) The All India Institute of Medical Sciences (AIIMS) Tuesday formed a five-member committee to probe the deaths of 49 infants during clinical trials at the institute.“A five-member committee, headed by neurology department head Madhuri Behari, has been formed. The report will be submitted within a week,” AIIMS spokesperson Y.K. Gupta said here.
The AIIMS set up the committee following a direction by the health ministry Monday.
In reply to a Right to Information (RTI) query, the AIIMS said 49 babies had died during clinical trials over the past two-and-a-half years.
The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.
However, AIIMS authorities said the deaths were not due to medicines used in the clinical trials but because of the diseases that the children were suffering from.
“We want to clarify that none of the deaths was due to the medication or interventions used in clinical trials,” V.K. Paul, head of the paediatrics department, had said.
“Clinical research is the mandate of the AIIMS clinicians. Novel therapies are examined keeping in mind the utmost safety for all patients,” he added.
“The research protocol undergoes intense scrutiny by the internationally recognised Institute Ethics Committee. Written informed consent is taken (from parents and guardians),” Paul said.
“Most of the 42 clinical trials have reported no deaths. The deaths are mainly due to inherent disease and not due to medicines used,” said Paul, who had answered the RTI query.
Tags: all india institute of medical sciences, india institute, intense scrutiny, k gupta, neurology department, novel therapies, paediatrics department, research protocol, two and a half years, utmost safety