CROs Blast New Clinical Trial Rules In India

CROs Blast New Clinical Trial Rules In India

January 10th, 2012 // 1:18 pm @

Overseas clinical trials are a perennially controversial issue, but especially in India, where the population is regularly tapped by overseas drugmakers. At the same time, the Indian government is increasingly concerned about patients. Notably, India’s health ministry last year found that drugmakers running clinical trials had not compensated survivors of most volunteers who died during their studies (see here).

And so the health ministry two months ago issued new rules that give Ethics Committees the latitude to review any injuries or deaths that occur during clinical trials and also establish compensation (read the rules here). The proposal, however, has drawn the ire of the Association of Clinical Research Organizations, the trade group, which recently wrote a scathing letter to Indian officials in which they blast .

“…The rulemaking process has moved away from, rather than toward, reasonable and responsible solutions to what are genuinely difficult issues,” ACRO executive director Doug Peddicord wrote to Arun Panda of the India’s Ministry of Health and Family Welfare. “If implemented as proposed, we fear that high quality, scientifically valid clinical research in India would become impossible.”

Why? ACRO offers a few reasons. One is that an ethics committee could be conflicted, since these may be associated with institutions running trials. The concern is that a committee might agree that a patient was harmed but blame the drug or device, rather than a physician or the institution. Moreover, ACRO believes most committee members would not be qualified to determine compensation.

Instead, the trade group wants an expert panel that includes the clinical trial investigator involved – or his or her representative; someone from the sponsor or CRO; and a member of the ethics committee overseeing the trial, along with at least two medical professionals who have “significant” experience in running trials not previously affiliated with the trial in question. Each panel would be approved by India’s Central Drugs Standard Control Organization.

ACRO also wants some language changed. For instance, the final rule should refer only to injuries related to a clinical trial. For instance, a recent story in The Washington Post noted that some 1,700 people who participated in trials in India died between 2007 and 2010, but no autopsies were performed to determine the causes of the deaths.

The trade group also wants some language removed that, in part, define when medical treatment or financial compensation is warranted. The draft would make this possible when an experimental drug failed to provide an intended therapeutic effect or a placebo failed to provide any benefit. “These two clauses show a fundamental lack of understanding of the scientific model of the clinical trial,” Peddicord writes.

Among other things, ACRO also does not want appeals filed to the same ethics committees, and objects to patient occupation and income included in consent forms. “We fear it could lead to discrimination against certain groups of patients based on their economic status and thus limit their ability to enroll in clinical trials,” Peddicord writes (read the ACRO letter here). Of course, if this approach were adopted, it would open the door to a flat rate for compensation.


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