The clinical research industry has witnessed a steep fall in the number of clinical trials over the past one year, due to lack of available centralised data and the impact of global recession. The number of trials fell by a whopping 31% in the year 2009 as compared to a 29% growth in 2008, according to the Indian Society for Clinical Research (ISCR).
Speaking to FE, ISCR president Arun Bhatt said, ?According to the globally collated data by clinicaltrials.gov?the trial registry site for all products subjected to Food and Drug Authority (FDA) approvals?the number of trials registered in India was down to 158 in 2009 compared to 229 in 2008, while the decline in the global average was about 11% to 7,023 from 7,941 last year.?
Trial registry in China and Korea, regarded as close competitors for India in this space, also saw a lower rate of decline at 4% and 6% respectively.
According to Bhatt, while the fall in numbers could be attributed to the global drop, a recession which affected small clinical research organisations (CRO) that drive the domestic market, and mergers of big pharmaceutical companies delaying decision making, factors such as unavailability of organised data on diseases and patient population, factual information about CROs and trial costs, restricted expertise, and poor international image, have also been keeping business away.
?Increasingly, projects are getting more and more complex, like projects on unusual cancers, or Alzheimer?s, which we have to turn down because we do not have adequate skills and experience,? said Bhatt.
He further added, ?There is no reliable data on Indian CROs and all data floating around is extrapolation at best. Even calling Indian CROs 40% cheaper than western CROs is an extrapolation and not an established fact. Also, negativity about Indian CROs is widespread due to the way it is portrayed and smaller companies abroad who don?t have adequate sources of information about Indian practices are afraid to bring their business here.?
While issues arising from lack of information about CROs are likely to be tackled through a mandatory CRO registration process to be put in place by the pharma industry watchdog Drug Controller General of India (DCGI), Bhatt said that a new committee comprising of members from organisations such as DCGI, Ficci, Assochem, as well ISCR and some non-governmental organisations was slated to meet next month to begin drafting a proposal for similar registrations for investigators and ethics committees for trials conducted in the country.