Monday, February 3, 2014

Video-recording of consent for clinical trials driving away subjects, SC told



Dhananjay Mahapatra,TNN | Jan 31, 2014, 03.27 AM IST

NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects           of the drug, which is under clinical trial. 

This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.
 The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. 

Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits. It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said. Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs     were    completed. 

From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.
 The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population.
Posted by:
Gauri Shah(Faculty)

1 comment:

  1. The new guidelines for the Clinical Trial Management may safeguard few lives and also helps those who suffered due to the clinical trials.

    ReplyDelete