As many as 211 people died in Indian clinical trials from January to June this year, The Times of India reports, and authorities are investigating how many were tied to the trials themselves or the result of disease.
The 6-month total is tracking a bit below 2011's 438 clinical trial deaths, which in turn fell from 2010's 668. Of more interest to India's Ministry of Health and Family Welfare, though, is how many of those fatalities are attributable to the trials and the drugs administered therein. In 2011, 16 deaths were caused by trials, preceded by 22 in 2010, according to the Times.
In the case of study-related death, the ministry requires study conductors to pay for medical care and disburse compensation to the patient's family. The amount of that compensation, though, is decided by the company holding the trial, something India's Central Drugs Standard Control Organization (CDSCO) is looking to change, according to the Times.
In 2010, most grieving families received between Rs 1.5 lakh and Rs 2.5 lakh (about $2,700 and $4,500) in one-time settlements, and only after CROs and pharma companies initially balked at paying anything, the Times reports. To better standardize the system, the CDSCO is proposing a compensation chart, dictating disbursements according to a patient's age: the younger the patient, the more a trial conductor would have to pay in the event of his or her death.
"When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug," a CDSCO official told the paper. "At present, both could get the same amount, and it could be abysmally low if decided by the pharmaceutical company."
However, addressing the issue of compensation skirts what many critics say is the problem with Indian trials: lax regulations that make it difficult to ensure safety and accountability. In India, there are no minimum clinical standards for trials, and the only requirement is medical supervision, meaning any doctor can administer a legal trial in a private clinic. This lack of oversight makes it impossible for regulators to make sure trials are safe, experts say.
- read the Times report