Martin Lachs PhD
VP, Project Management, Oncology and Hematology, Clinical Research Services, ICON plc
Although Asia Pacific (APAC) is sometimes referred to as a homogenous unit, it is a heterogeneous region, with divergent countries, languages, populations and cultures.
Clinical research in APAC is well established with many multinational pharmaceutical companies and CROs having been in the region for more than 2 decades, so there is a great depth of experience to draw on. The main pharmaceutical markets – Japan, China, South Korea, Taiwan and Australia – have different business, labour and regulatory environments, therefore the characteristics of clinical development differ.
The size and significance of the APAC market and the needs of its populations make clinical trials, on the cutting edge of oncology development, an attractive investment. Oncology and immuno-oncology are important areas of research in the region, with China in particular being a key country for adoptive cell transfer (ACT) studies, and this trend is likely to continue. Until fairly recently, most of the target indications for ACT have been haematological cancers but this is now expanding to sarcomas and solid tumours.
In oncology, the pharmacogenomic profile of the Asian population is an important factor that necessitates the requirement for Phase I data in local populations. One example is the genetic polymorphism for P450 enzymes that can lead to substantial variation in drug pharmacokinetics in different populations.
Access to resources to operationalise clinical trials varies significantly between countries in APAC and therefore bespoke strategies are often required in the different constituent nations. Compared with Europe and the US, there is much greater spectrum in APAC in the ease of site access, particularly for oncology trials. For site access across the region, potential bottlenecks are not due to patient access but rather the time investigators and study coordinators have available to conduct clinical studies, and oncology study sites are especially busy.
APAC undoubtedly has a strong medical oncology community but it requires a level of attention to navigate it successfully. The region will continue to be a major focus for multinational pharmaceutical companies in the future.
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This blog is an edited version of “Oncology Clinical Trials in APAC” which appeared in SCRIP Asia 100 in November 2018.Read the full article here
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