New Delhi: An audit of a clinical trial conducted at the Bhopal Memorial Hospital and Research Centre (BMHRC) for Quintiles Transnational Corp. shows people who had enrolled for the trial were not compensated for the expenses incurred to participate in it.
“Our report shows that compensation wasn’t given to subjects. We haven’t found any other major violation except that reporting timeline was not followed by the investigator,” said an official at the health ministry’s Central Drugs Standard Control Organisation (CDSCO) on condition of anonymity, as he is not authorized to speak to the media. “Now we have asked them to explain their position before we take any further steps.”
Quintiles did not respond immediately to an email query by Mint.
A member of the BMHRC ethics committee declined to comment. The hospital’s spokesperson could not be contacted.
Drugs controller general of India (DCGI) Surinder Singh has written to Quintiles and to the clinical trial investigator at BMHRC asking for an explanation.
Mint reported in August that the regulator had ordered an audit of a clinical trial conducted by Quintiles at BMHRC on behalf of US-based innovator firm Theravance Inc. The trial was for its pneumonia drug Vibativ (whose generic name is telavancin).
A person enrolling for a clinical trial is considered a part of a study and is paid a compensation for expenses incurred in related travel and other costs. This is mandatory.
“The subject has to be paid for the inconvenience as per law. They don’t have to be paid a hefty amount because that encourages people to enroll for multiple, sometimes concurrent trials. But they have to be compensated nonetheless,” said the CDSCO official.
The Drugs and Cosmetics Act of India doesn’t lay down a compensation amount for trial subjects. It doesn’t lay down any penalties for violations of clinical trial rules either.
“Compensation is the biggest thing, most important aspect. Everything else is an academic exercise,” said C.M. Gulhati, editor of the medical journal Monthly Index of Medical Specialities.
“If the subject didn’t receive compensation, then that in itself is an admission that there has been a violation. How can you test a drug on a subject and then not give them any compensation for it?” he said.
BMHRC reportedly conducted clinical trials on victims of the Bhopal gas tragedy between 2004 and 2008. Seven such trials have come under the regulator’s lens.
The trials were stopped after reports of the deaths of 49 babies at the All India Institute of Medical Sciences, New Delhi, in clinical trials between January 2006 and June 2008.
Following this, DCGI ordered an audit of the clinical trial at BMHRC, especially as the hospital was entrusted with treating victims of the gas tragedy and conducting research into preparations for such emergencies.
The Theravance-sponsored trial received DCGI’s approval in April 2006 for testing the drug for hospital-acquired pneumonia (HAP).
Currently, the drug is approved for marketing in the US only for one indication—skin infections.
This approval was received in September 2009.
In November, the US Food and Drug Administration (FDA) asked for additional data to approve the drug for HAP. In January, the additional data supplied was deemed “incomplete” by FDA.
Theravance and its contract clinical research organization (CRO) Quintiles completed the telavancin trial in India in June 2007 after having screened eight people, while only four completed the trial.
During the one-year period of the trial, three deaths occurred.