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'Illiterate Persons Not to Be Used for Clinical Trials'

'Illiterate persons not to be used for clinical trials' [Hyderabad] [Times of India]

From Times of India (September 7, 2011)


HYDERABAD: Reeling under allegations of using poor and illiterate people as guinea pigs for clinical trials, five of the 12 registered clinical research organisations in the state have formed a forum 'AP CRO' and claims that they would now take video and audio recordings of the consent process at the time of enrolling volunteers. Some claimed to have even decided against using illiterate volunteers for trials.

Representatives of these CROs said on Tuesday that the forum has been formed to build awareness about clinical research industry and promote ethical practices among all CROs. The forum will work closely with Drug Controller General of India (DCGI) for better adherence and to address transparency issues.

Officials of CROs said that although clinical trials were necessary for any generic medicine to determine their safety and efficacy, they are only used on patients who have no other treatment option. Referring to cancer medicines, R Sirish Kumar, director and CEO, R A Chem Pharma Ltd. said, "The medicine is given as per necessity. If the medicine has been designed for cervical cancer, only cervical cancer patients will be given the dose, if need be."

Axis Clinicals, that was in the news recently after DCGI cancelled its license following its anti-cancer drug trials on poor uninformed women going wrong, is also part of the forum. The DCGI had in August-end lifted the suspension on Axis to conduct clinical trials.

The APCRO forum volunteers have also initiated a discussion with various registered CROs in the state to implement a common database. The audio visual recordings will be sent to DCGI every year, instead of two years as being the practice earlier, to maintain more transparency. Officials of CROs maintained that the allegations leveled against them over the last few months were not unwarranted. "We do not lure illiterate people. In fact, when these illiterate people sign the consent form it is mandatory that one literate guardian has to accompany the person," said Sunil Reddy, director, QPS Bioserve adding that in case of any unwanted condition the CRO and the sponsor for the medicine bears the complete cost of recovery for the subject. "To put an end to this controversy, many CROs have decided not to take illiterate subjects," he added.

There are approximately 40 CROs in India of which 12 are in Andhra Pradesh.

Posted: September 2011