Andhra Pradesh CROs establish transparency forum
The new group, named AP CRO, includes Axis Clinicals, QPS BioServe India, Sipra Labs, Aizant Drug Research Solutions and CRBio and is intended as a self-regulating body designed to ensure the research is carried out in an ethical manner, according to the Times of India.
One of AP CRO’s first activities will be to develop a programme whereby video and audio recordings are taken as patients enrol in trials to address concerns that participants, particularly in rural areas, are sometimes not made properly aware they are taking part in research.
AP CRO member Axis Clinicals, part of Aurobindo Pharma, was the focus of such concerns in June after the DCGI banned it from conducting bioequivalency and bioavailability studies after allegations the CRO had failed to obtain consent from women enrolled in a cancer study it carried out in Pidugualla.
The DCGI gave Axis the go ahead to resume conducting clinical trials last month after inspecting the firm’s facility in Miyapur in the city and the CRO revised some of its recruitment protocols.
Nevertheless, this and a number of other incidents have started to tarnish the reputation of clinical research conducted in India and those in Andhra Pradesh in particular – hence the decision to establish the new self-regulatory body.
Axis MD Sarath Reddy told the Hindu Business Line that: “We have decided to maintain video and audio recording of the consent process at the time of enrolling volunteers to rule out any deficiencies and complaints of inadequate briefing of volunteers.”
Sunil Reddy from QPS Bioserve went further, telling the Times of India that: "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.”
"To put an end to this controversy, many CROs have decided not to take illiterate subjects," he added.
