Why Outdated Perceptions of APAC Clinical Trial Sites Persist Among Smaller Biotechs

Full interview summary

In a recent video interview with Applied Clinical Trials, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, discussed why outdated perceptions of APAC clinical trial sites persist among smaller biotechs and what those sponsors need to understand to run Phase III trials in the region successfully. He opened by explaining that APAC joined the global clinical trial space later than the US and Europe, but has since made significant regulatory improvements. China is the clearest example: approval timelines that once took a year have fallen to roughly six and a half months, and under certain risk-sharing conditions, review can take as little as 30 days. Sponsors whose experience dates back five or ten years, he argued, need to update their assumptions.

On quality, Cheong pointed to FDA inspection data showing that findings at APAC sites fall into the same categories, and at similar rates, as those in the US and Europe. Based on his own experience, the findings are also similar in nature, most often informed consent versioning and incomplete source data, with nothing unique to the region.

He attributed China’s improvement to deliberate policy choices by the NMPA, which wants to eliminate drug lag and be on par with leading agencies. The 2015 reforms signaled zero tolerance for poor quality, which caused poorly managed trials to withdraw, while expanded reviewer capacity and parallel ethics and regulatory review further compressed timelines. With translation requirements factored in, startup can be as short as three to four months.

Cheong closed by explaining what large pharma has already figured out: APAC offers faster recruitment, in some oncology indications two to three times higher than in the US or Europe, local data requirements for registration in countries such as China and Japan, and lower costs. For smaller biotechs running a first APAC Phase III, he stressed three priorities: aligning country selection with future marketing authorization plans, choosing the right sites, and partnering with a CRO that has real regional experience and KOL networks.