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 robustness of the infrastructure currently in place.
Last September, after getting approval from the Drug Controller General (India) 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 Phase IIb 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, and decided to terminate the study at the site. They also initiated action against the investigator and informed the DCGI of these occurrences.
While the trial continues at the other 27 sites across the country, 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, such cases of whistle blowers should be encouraged because it is a sign of increasing maturity and transparency of industry players.
The number of trials conducted in India is only going to increase and if we consider that Indian patients will make up even 20 percent of the total number of patients participating in global clinical trials, this translates into a market worth $1.5-2 billion by 2010.
Much of the cost of a clinical trial comes from the cost of recruiting patients and it is well documented that compensation rates in developing countries fall way below those made to volunteers in Western countries. Even at these reduced rates, Indian patients are easy prey, given poverty levels in the hinterland areas. For some patients, being on a clinical trial simply means an assured better standard of clinical care, which otherwise would have been out of reach.
India?s low literacy levels also means that standard Western ?informed consent form? formats could be merely a leap of faith. The faith of a patient/ volunteer in his family doctor, or simply ?the man in a white coat?. Many sponsors and CROs have overcome these problems with enhanced informed consent forms and procedures but can we tap this market, while at the same time safeguarding the interests of these patients/volunteers?
There is also a debate on whether government run hospitals would be better guardians of these interests or private trust hospitals. One camp suggest that the former lack the infrastructure and are therefore more prone to the temptation to make a quick buck; the rival camp points out that private trust hospitals are not transparent in their dealings and are therefore more likely to get away with fraud.
Blacklisting defaulting investigators seems to be one way of successfully checking this rot. The US Food and Drug Administration?s 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?.
viveka.r@expressindia.com