Even as the dust is yet to settle down over the HPV vaccine trial and death of three tribal girls in Andhra Pradesh, records showed that the total number of deaths among the clinical trial subjects, though not officially termed as part of the trials, are on the increase in India.
The data available with the authorities showed that 132 people died during the trials in 2007 while the number went up to 288 in 2008. As per the information collected so far, as many as 308 persons died in 2009 upto August. However, none of the deaths occurred because of the lapse in the clinical trials as per the official claims, though the public interest groups think otherwise.
“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. Such deaths are investigated for causal relationship by investigator and by medical experts of sponsor,” according to official explanation.
Recently, Andhra Pradesh witnessed a controversy over the death of three tribal girls. Denying the blame against the clinical trials, which supposedly caused the deaths in Khammam district, health minister D Nagender said that the two girls committed suicide whereas the third passed away due to viral fever.
The deaths of 49 children during their clinical trial at the AIIMS over the past three years also had created controversy in August 2008. However, the inquiry by the expert panel claimed that the drugs used for the trials were safe and not known for fatal complications. The premier health institute declared that the children were victim of serous and high risk diseases.
According to the official sources, the number of clinical trials actually conducted in government/private hospitals are not available with the CDSCO as prior to November 17, 2008, as registration of clinical trial was voluntary. The number of clinical trial permissions granted by CDSCO to firms/sponsors/government hospitals/private hospitals between January, 2004 and December, 2009 is approximately 2000, sources said.
From June 15, 2009, it has been made mandatory to register all clinical trials permitted on or after the said date at Indian Council of Medical Research (ICMR) registry at www.ctri.in before enrolling first patient in the study. Such registration will improve transparency and accountability of all stake holders involved in clinical trials, sources added.
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