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A person undergoing clinical trial wouldn’t become eligible for financial compensation just because a new investigational potential drug fails to deliver the desired results, the Drug Technical Advisory Board, the apex decision-making body on drugs safety has recommended in a recent meeting.

It has also suggested, that if the subject is put under a placebo in a clinical trial, but is not taken off his standard medical regimen, he cannot claim financial compensation for an adverse event.

For instance, if a hypertensive patient is on a cholesterol-lowering drug, but is undergoing a clinical trial for a new skincare molecule, during which the doctor asks him to continue taking his prescribed medication but administers placebo for the trial, he would not be eligible for compensation for an adverse effect.

But the patient must be explained in detail about the lack of therapeutic effect, at the time when informed consent is taken from him, before the trial starts.

However, if the patient has been directed to stop his regular medication during the placebo trials, and he or she suffers an adverse event, the volunteer can claim compensation for the same.

The technical board has also clarified that the pharma companies or other sponsor of the clinical trial would have to pay for the free medical management of a subject, only if the injury in question is related or caused by the trial.

“Medical management should be provided in case the injury is due to clinical trial related activities only, as the free medical management may create undue influence for patient to enroll in a clinical trial,” the board said. The contract research organisations and clinical research industry has welcomed the changes.

“This clarification was important as a clinical trial sponsor should not have to provide for medical management of a non-related injury suffered by a subject, for instance, a road accident. Also, free medical management itself shouldn’t become an inducement for any person to be part of any trial,” said Saurendra Das, utive director, Excel Life Sciences, a US-headquartered clinical trial management service provider.

The recommendation on compensation rule which removes compulsion on sponsor to pay up even if product doesn’t give benefits is a step in the right direction and would spur innovation, he added.

The government had put in place a set of rules early this year to streamline compensation and other processes for governing clinical trial in the country.

Before that, the country had guidelines but no law in the clinical trial space, which could make it mandatory for pharma companies to pay, if a clinical trial subject suffered an adverse impact.

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