Applied Clinical Trials
Conducting clinical research in the East brings a new group of challenges to sponsors
With every aspect of drug development moving east, there are only two kinds of clinical trial sponsors: those running sites in Asia, and those thinking about running sites in Asia.
For the latter, Asia appears from afar an impenetrable black box. While that box is rumored to hold significant cost savings and access to the fastest-growing healthcare market in the world, tapping into it means navigating regulatory and operational challenges compounded by language barriers.
Even for drug and device developers with established clinical trial sites in Asia, expanding from one country to the next can pose challenges. Each country has its own distinct cost structure, population base, medical practice standards, infrastructure, government policies, and cultural differences.
Most drug developers are aware that conducting preclinical research in Asia is far more cost-efficient than conducting the same research in America or Western Europe. Many drug developers are rapidly discovering the same is true with clinical trials. Running trial sites in China, Thailand, the Philippines, or Malaysia can save a sponsor 60 percent. Most countries in Asia are at least 20 percent to 30 percent more cost-efficient than their western counterparts, but there are exceptions to every rule.
With more than 4 billion people, Asia offers sponsors a deep pool from which to draw trial participants. In particular, sponsors may want to consider enrolling patients in highly populous countries like India, China, Indonesia, Japan, the Philippines, Thailand, and Malaysia. However, sponsors must be aware that competition for participants in countries like China is increasing. A country like South Korea may be less populous than China, but it still boasts roughly 50 million people and, as an emerging region for clinical research, may offer less competition for enrollment.
The incidence of the target disease in each country's population may also play a role in trial site planning. Asia offers relatively more patients for first-line and second-line cancer drug evaluation than the West, where such patient stores have been largely exhausted. Highly developed Asian countries have a higher incidence of diseases common in the West, like obesity and diabetes, while diseases like tuberculosis are more common in Southeast Asia. Some countries, like India, have diverse patient populations afflicted with diseases of both the developing and developed world.
There are certain diseases for which the standard-of-care in Asia is similar to that in the western world, including breast cancer, lung cancer, and diabetes. Sponsors of clinical trials in these indications can feel relatively comfortable establishing trial sites in any Asian country. But for many indications, medical practice standards differ both from East to West and between the different Asian regions.
Principal investigators in the United States and Western Europe have been running clinical trials for 40-plus years—their counterparts in Asia are lucky to have half as much experience. Sponsors should be prepared that Asian trial sites—even those that have adapted Western-style medical practices—may need more assistance when it comes to following protocol and differentiating between medical practice and clinical research. Sponsors should not assume that all potential Asian trial sites will have the infrastructure—even fax machines or freezers—needed for a clinical trial. Fortunately, vendors of clinical trial services from data storage to cold-chain supply are following the Eastern migration of research and making everyone's job easier.
Each Asian country's policies on protocol approvals, insurance regulations, import licenses, and myriad other factors can affect a sponsor's ability to establish and run a site. Ironically, countries like China and Thailand, which have historically been considered "easy" targets for clinical trials, are now increasing their regulations and making the trial review and approval process more formal, demanding, and time-consuming. China in particular is associated with a relatively long lead time for getting protocols approved and trials operational. Meanwhile South Korea and Taiwan are starting to realize that participation in global clinical trials is critical to advancing their medical practice standards, and are working to ease regulations and facilitate protocol reviews.
The regulatory bodies in South Korea and Taiwan, as well as in Singapore, have adopted an FDA flavor to their practices, so sponsors may not feel as much culture shock when dealing with them. Yet each Asian country has its own regulatory idiosyncrasies. No matter how harmonized Asia may appear, the cookie-cutter approach simply doesn't work. Clinical trial sponsors must consider their regulatory strategy in Asia as part of their overall business strategy, not as an afterthought. It's a process that needs to be started early, yet it is dynamic and should be revisited often.
Language barriers can be easily overcome by CRO partners with offices across Asia, and sponsors are often pleased to learn that investigators in most Asian countries are eager to participate in clinical research. It is viewed as a way to advance their quality of care and position themselves on the cutting edge of scientific innovation. Regulatory reviewers, too, are often eager to help, if a sponsor knows what questions to ask and how to ask them.
Yet there are certain cultural considerations that sponsors need to address upfront. For example, some Asian researchers may believe that their participation in a trial gives them the right to publish data on their findings, while sponsors require at least some degree of control over the publication of trial data.
As the fastest-growing pharmaceutical market in the world, China is a major consideration in the marketing plans of most drug developers. Biotechnology and pharmaceutical companies are often interested in establishing trial sites in China as part of a plan to support eventual approval in Chinese markets, and the same is true of Japan. In addition, there are certain diseases that present a serious unmet medical need specifically within Asian populations, such as foot-and-mouth disease. Such indications obviously lend themselves to Asian clinical trials. Yet if a sponsor has no plans to launch a drug in certain Asian countries, then conducting clinical research in those countries may present ethical challenges.
Jessica Liu, MD, Senior Director of Clinical Operations, Head of Asia-Pacific, Global Operations, INC Research.