Better monitoring of clinical research an imperative

Todd Clark, president, Value of Insight Consulting Inc, recently came up with an outstanding report on behalf of the Association of Clinical Research Organisations titled “The Case for Globalisation: Ethical and Business Considerations for Clinical Research.”

The report, prepared for the Pharmaceutical Research and Manufacturers of America (PhRMA) members, brings out a number of perspectives about the need of global clinical trials, the progress made in enriching pipelines due to multi-centric trials and the further need to involve emerging markets for quicker patient enrolments and cutting time-to-market products.

One of the important reference points in the report is about India.

Diversity of population, talent pool and the quality of standard procedures are among the factors that have led to an unprecedented growth in the Indian clinical research industry.

By unofficial estimates, the industry has neared a billion dollars in total revenues from a few million in the early part of the decade. But the most glaring point that comes out of Clark’s investigation is probably that the cost arbitrage India had a few years ago has been fading rapidly.

Though there is no direct reference to the actual cost of trials in India, the author says, “Lower cost is the usual reason cited for conducting clinical trials in emerging markets and this is an important factor. The cost per patient in India and China has been estimated at one-third of that in the United States. Although per patient costs are lower, when logistical and other factors are considered, the fully loaded cost of conducting studies in developing countries often approaches levels that would be found in more established areas.”

This statement could be a wake-up call for the clinical research industry in India as the uneasy feeling may have been around vaguely but never documented. Around two years ago, Pfizer wound up its Chennai-based clinical research support functions and shifted it to China. Cost may not have been the only determinant for that move but multinational companies evaluate every single factor before taking a decision as serious as shifting functions and locations. Every dollar saved is critical to a company and the ambition of strengthening presence in emerging markets is now coming with a lot of rationality.

With the number of cancer patients willing to go for clinical trials in the US dwindling to a minuscule level, research firms are finding it easier to enroll patients in India. But many in the Indian industry say the principal investigators have turned extremely greedy and medical teams are trying desperately to balance the need for involving the investigators and keeping the costs within control to keep the headquarters convinced about India.

According to people in the know, some of the investigators charge no less than $4,000-5000 per cancer patient and that amount has doubled in the last two or three years.
Clark’s report, however, plays up the importance of doing trials in the emerging markets.

“In truth, the largest benefit of globalised trials comes from faster time to market - reducing development time by half results in nearly two-thirds reduction in overall development cost and provides a longer post-approval patent term in which to recoup the investment. Faster trials also mean that patients are able to access safe and effective medicines more quickly,” the report states.

Therefore, while there is a telling need to bag projects and see that multinationals continue to prefer India over other emerging markets, the Indian clinical research industry will have
to check the spiralling costs and absorb the mounting demand. The requirement for enrolling patients is pushing companies to see if other countries like Singapore, Taiwan, Indonesia, Korea and Brazil could be better destinations.

Professionals in the clinical research industry also believe that because of the increasing number of trials in the last few years, the relevance of emerging markets will be more from patient recruitment angle and generating data but that may not be the right method to retain competitiveness.

Clark’s findings suggest that in February 2009, there were approximately 2,900 new drug compounds in clinical trials or undergoing FDA review, a 52.6% increase over 1999 levels. Further, the average number of days to complete a trial grew 70% between 1999 and 2005, while enrolment rates declined 21% and retention rates fell 30%.

Though patient enrolment costs are comparatively lower in India, that advantage is gradually getting blunted as the time taken to complete the trials have increased significantly.

Our clinical research industry has been able to make a marked difference in terms of quality of data but the concerns of too many people battling for the same pie may result in a disastrous fall. Any wrong trial data can tarnish the entire industry’s reputation and that is the reason the drug regulator needs to act fast to harmonise its functions with the global regulators at the earliest, for better monitoring.

Pillman is an executive closely linked to the global pharma industry.