Strict regulations for clinical trials

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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.”

Ref and Read more: http://articles.timesofindia.indiatimes.com/2011-09-07/hyderabad/30122246_1_cros-clinical-trials-axis-clinicals

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