A recent article in Outsourcing Pharma examined the state of clinical trials in China, India and Japan, and whether the recent boom in clinical trials in Asia was likely to turn into a bust. While we agree with most points in the article, my colleague, Barb Geiger, and I felt it was important to note that the challenges and strengths facing clinical trials in Asia vary from country to country.
In our experience, one of the biggest frustrations for US and European sponsors conducting clinical trials in China is the slow trial approval time. Presently, it can take a year to get a study up and running. However, the Chinese government and regulators have demonstrated commitment to building a domestic pharmaceutical industry of which clinical research is an integral component. Historically, they have shown the ability to move decisively in terms of regulatory changes, and so we don’t doubt that the regulatory challenges to clinical research in China are surmountable.
It’s also necessary to point out that the regulatory challenges in China are somewhat separate from the capacity issues in the region. Specifically, while there are large hospitals and many, many patients, the number of investigators is limited and the government has approved only a limited number of hospitals for participation in clinical trials. So there wasn’t much excess capacity for a lot of new clinical trials prior to the crackdown. We don’t expect the country to approve large increases in sites or investigators until after their current anti-corruption crackdown ends.
Historically, these anti-corruption crackdowns happen every few years, so it is safe to view the current activity as part of that pattern. However, it is noteworthy that multinational firms were targeted this time and that differentiates it from the previous crackdown in 2006-2007.
We perceive the situation in India to be quite different. There is much more political pressure on the government to rein in clinical research. This comes on top of the longstanding hostility towards drug patents and the lassitude of regulators in the review of clinical trial applications.
India certainly can support a lot of clinical research and has both a domestic pharmaceutical and a domestic CRO industry. While both industries have seen a great deal of success, the problem is that they still remain reliant on generics and related bioequivalency trials. Until that changes, and they begin to view new drug development as more of a national priority, we predict the road will continue to be rocky.
The issues in India also seem to recur with some regularity. Although conditions for clinical trials have improved over time, there has been a lot of discussion around these particular challenges for more than ten years. We expect that India will remain important for non-clinical aspects of clinical research, such as data management and eClinical software development, but it will more than likely be some time before things improve on the clinical research side.
As we mentioned earlier, while China and India face their own challenges, all of Asia shouldn’t be painted with the same brush. While China and India both have large populations, which are necessary for studies with large enrollment goals, more and more clinical trials continue to move towards Southeast Asia—especially to countries including Korea, Singapore and Taiwan. Smaller studies, such as a phase 2 oncology study, may have more success in one of these smaller countries where investigator enthusiasm is high, approval time is fast, enrollment goals are met and there is a high quality of data.