Head of the Department of Paediatrics Dr V K Paul said all 49 kids were mortally sick and died naturally, not due to any drugs used in the trials. “The trials would have been stopped in between if the children had died due to the drug intervention. The data safety management board, which comprises experts, keeps a regular check on the trials,” he added.

In reply to an RTI application filed by Udyog Foundation, an NGO, the AIIMS administration said as many as 49 children had died during clinical trials of new medicines in the premier institute during the past two-and-a-half years.

A total of 4,142 children, of whom 2,728 were aged below a year, had been enrolled for clinical trials of new drugs and therapies by the Department of Paediatrics since January 1, 2006. However, the total number of deaths includes both the kids who were on standard drug management and those who were given new intervention along with the standard medication. “This doesn’t mean that all those children who were tested for new drugs have died,” added a doctor.

Before conducting any human trial, a comprehensive exercise is done. A research questionnaire is formed, defining the criteria of the study. The proposal is then sent to the sponsoring agency, which could be World Health Organisation (WHO), Indian Council of Medical Research (ICMR), or UNICEF. The funding agency then gets it reviewed independently and gives the go-ahead.

ICMR guidelines, however, say children should not be included in the studies if these can be conducted on adults. “There are certain diseases like jaundice in children, neonatology highline membrane disease, sepsis where inclusion of children becomes mandatory as the diseases involve children,” added Dr Paul.

Once the inclusion criteria of the subjects is reviewed by the ethics committee, the funding agency gets it reviewed by their set of experts which is then followed by funds provided by them. The parents are also brought into the loop for including their children in the trials. “Parents are given a consent form by the ethics committee. A patient information sheet is developed in which study risks are also mentioned. The children are included only when the parents give their written consent,” said Dr Shinjini Bhatnagar of AIIMS.

Dr M K Bhan, head of Department of Biotechnology, said the trials were done in the best possible way. “As many as 1-3 per cent patients always die when the trials are conducted as these are severely ill patients. These are the best trials as 30 per cent reduction in death rate has been seen,” he added.

Said Dr Nikhil Tandon, endocrinologist, AIIMS, a former member secretary of the ethics committee: “Multiple checks and balances are maintained before conducting such trials. All trails are taken up only after having multiple discussions with the ethics committee. The committee checks if the project is ethically correct or not, whether it is to be done. The committee may then suggest some modifications. If a new agent is to be used in the trial, consent by the Drug Controller General of India (DCGI) becomes mandatory. The ethics committee then has an advisory role.”

Doctors say ICMR guidelines are followed by the trial-conducting agencies.

To keep a further check on the trials, a Central Data Safety Management Board (DSMB), which comprises independent experts, is formed. “Their work is data safety. The DSMB can stop the trials anytime if they see any problems,” added Dr Paul.

The 42 clinical trials were conducted for different drugs like zinc tablets for treating zinc deficiency, rituximab, olmesartan and valsartan for treating blood pressure-related problems and gene-activated human glucocerbrosidase for liver-related ailments.

However, the doctors conducting the trials claimed the intervention of some of these drugs had turned out to be effective. “The study using rituximab has been conducted amongst children between 3-16 years of age for kidney diseases. Results have been very good. The study was conducted on 22 children, and no death has occurred so far,” said Dr Arvind Bagga, Department of Paediatrics, AIIMS.