In recent years, the clinical trial landscape in Asia and the Pacific Rim has evolved faster than in most other regions. More than half of the world’s population lives in this rapidly developing area, which includes advanced economies such as Australia, Singapore and South Korea, as well as countries with vast populations like India and China.
The attraction of being able to generate quality clinical data not only from the traditional geographies of North America and Europe but also from large pools of potential trial patients in Asia can be hard to resist, but what of the challenges? I suggest a starting point to be a critical appraisal of what the region may be able to offer any specific program. This will usually require partnering with an expert in the region, but the following brief list can act as an initial guide:
Phase of study: Though the more populous Asian countries may be an obvious choice for larger studies, typically Australia is a favored destination for early phase work. This is driven by a favorable regulatory environment and generous government subsidies, as well as a recently depreciating Australian dollar.
Therapeutic area: For many indications, there is no appreciable difference in disease demographics and incidence around the world. For some conditions, however, the difference can be staggering. For example, for many hepatic conditions (e.g., Hep B), some oncology indications (e.g., gastric cancer, HCC), most of the world’s patients may be in the Asia-Pacific region. Conversely, for certain genetic disorders, there may be hardly any.
Regulatory requirements and timelines: These can vary significantly across individual countries in the region, both in terms of timelines and data requirements. It’s best to engage early in the planning process and typically allow three to six months, depending on the country of interest (and longer for some, such as China).
Written by Guest Writer Alek Safarian. Safarian, B.Pharm, M.B.A., is CEO of Novotech, an Australia-based CRO with operations throughout Asia-Pacific. Trained as a pharmacist, he was previously responsible for Asia-Pacific regulatory affairs operations for a global pharmaceutical company.
This article was reprinted from Volume 22, Issue 12, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
