A double edged sword
Opportunity seems to be a double edge sword for Indian clinical research industry. While we have numerous reports on the potential size of the market, the operative word seems to be ‘potential’. For instance, in 2005, only one percent of global trials were conducted in India. Reports project that this figure will grow to 15 percent in 2011. While this points to the tremendous scope for growth, does it also mean that India is still in the (early?) stages of building up a sturdy clinical trial infrastructure? A recent case could be cited as proof of the robust ness of the infrastructure currently in place.
Last September, after getting DCGI approval for the study for 28 sites, Mumbai-based Glenmark Pharma contracted Omnicare Clinical Research, a US based clinical research organisation (CRO) to do the Phase IIb study of Oglemilast, its lead asthma molecule. The study was initiated in mid November in these sites across the country, after Omnicare appointed lead investigators who got the necessary approvals from the ethics committees (ECs) at the respective sites.
The CRO started getting suspicious of the early data coming in from a site in Jamnagar, Gujarat around February and increased monitoring activities in March. The CRO and sponsor jointly conducted a detailed review which confirmed their suspicions regarding EC committee documentation provided by the investigator.
The sponsor and CRO subsequently conducted a for-cause audit on March 23 and once the fraud was confirmed, informed the chairman of the EC, (also the superintendent of the hospital where the trial was conducted) and decided to terminate the study at the site. They also initiated action against the investigator and informed the Drug Controller General (India) (DCGI) of these occurrences.
While the trial continues at the other 27 sites across the country, industry observers point out that the sponsor and CRO need a pat-on-the back for drawing this to the attention of the DCGI. It is testimony to the fact that checks and balances already built into India’s clinical trial regulatory system are working well. While the DCGI is yet to conduct its own audit of the site, observers point out that such cases of whistle blowers should be encouraged and defaulting investigators blacklisted so that the rot does not spread. The US Food and Drug Administration’s (US FDA) website regularly updates its lists of clinical investigators who have been disqualified or “totally restricted” or partially restricted from conducting clinical research. India desperately needs a similar listing of ‘black sheep’.
Sources also point out that there have been cases of sponsors ignoring or delaying action on red flag alerts raised by CRO personnel. In this case, even a slight suspicion should be cause enough to do a site audit, as an audit will not only flush out the defaulters, but also raise general quality standards by putting everybody at the site on ‘best behavior’. After all, it is better to be safe rather than sorry.