Source : Pharmabiz News – September 09, 2011, 0800 IST
To bring transparency and promote good practices among the Clinical Research Organizations (CROs), some clinical research organizations have formed a forum in Andhra Pradesh. This forum has decided to maintain video and audio recordings of volunteers of trials, but loopholes and contradictions still exist in the process.
“We have formed a forum called the AP Clinical Research Organization (APCRO); initially it is a group of five out of 12 CROs in the state. Our main focus is to build awareness about clinical research industry and promote good practices amongst our members. It will also work closely with the Drug Controller General of India (DCGI) for better adherence of rules and address transparency issues and will maintain video and audio recordings of volunteers,” said R. Sirish Kumar, CEO, CRBio.
The five organizations that have come together to the form the forum are QPS Bioserve India, Sipra Labs, Azis Clinicals, Aizant Drug Research solutions and CRBio. Video and audio recordings of the consent process at the time of enrolling volunteers will be made to rule out any deficiencies and complaints of inadequate briefing of volunteers.
“In the case of illiterate volunteers from rural and tribal areas, the bioequivalence process will be explained to a legal heir or a blood relative, who is literate enough to understand it,” said Sirish.
Clinical trials are undertaken by pharma companies, and CROs are concerned with the bioequivalence (BE) studies, which is administering a single dose of the existing generic drug to healthy people and is safer than clinical trials, which is done on patients. Today the BE study is a $100 million industry in India. However, trials need to be conducted in the local, ethnic population to evaluate the efficacy of drugs.
Dr V Satyanarayana, managing director of Sipra Labs, said, “A common volunteer data base will be compiled to prevent cross participation. The DCGI will conduct annual inspections and monitor it at regular intervals.”