Illiterate persons not to be used for clinical trials
HYDERABAD, Andhra Pradesh, INDIA: Five of the state’s 12 registered CROs have come together to create a forum called the “AP CRO” after being staggered in a pool of allegations of luring poor and illiterate people as guinea pigs for clinical trials. The forum comprising the 5 CROs claims that it will now document the consent process of recruiting participants by means of an audio-visual recording, while few CROs in particular have even decided against the use of illiterate participants in trials.
Earlier on Tuesday, forum representatives revealed that the motive behind this endeavor was to increase awareness about clinical research and encourage ethical practices among CROs during the conduct of a trial. In order to ensure better adherence and address transparency issues, the forum is said to work in close cohesion with the Drug Controller General of India (DCGI).
CRO officials said that although clinical trials were imperative to determine the safety and efficacy of generic medicines, only those patients who have no other treatment option are recruited for the study. In view of cancer drugs, director and CEO of R A Chem Pharma Ltd. R Sirish Kumar 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.”
One of the CROs on the forum is also Axis Clinicals that was in recent news after the DCGI revoked its license for involving poor uninformed women in anti-cancer drug trials, which went wrong. Towards the end of August, the DCGI lifted the suspension off Axis Clinicals.
In an effort to implement a common database, volunteers of the APCRO forum are in discussions with several registered CROs in the state. To maintain more transparency, audio-visual recordings will be sent to the DCGI annually rather than 2 years as practiced formerly. CRO representatives have been consistent in their statements that allegations against them over the past few months were not uncalled-for. Sunil Reddy, director of QPS Bioserve said, “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,” He further stated that the CRO and sponsor take up the complete cost of medication and recovery, in view of an unforeseen health condition in the subject. He added, “To put an end to this controversy, many CROs have decided not to take illiterate subjects.”
Andhra Pradesh houses 12 of the 40 CROs contained in India.