China’s clinical talent gap
How Chinese companies are finding the clinical experts they need to run local trials
While regulatory changes in China have helped clear the way for rapid growth of its clinical trial infrastructure, the country’s dearth of clinical experts could hold back the expansion until new talent is up to speed. The shortfall could to take up to five years to resolve.
Last year, China’s National Medical Products Administration (NMPA) made it easier to qualify hospitals to run clinical trials and shortened the time it takes to start Phase I testing. But stakeholders contacted by BioCentury think there aren’t enough clinical trial experts in the country to take advantage of the changes.
The shortage includes industry personnel with experience managing clinical trials and strategy, and physicians to conduct the studies.
Onboarding clinical expertise will be important as companies aim to create a cohesive strategy across trial designs and analyses, regulatory interactions and international development plans.
“Temporarily, it is a bottleneck in China to have a shortage of talent who really understand a global drug development scheme and are able to interpret data and communicate effectively with the Chinese regulatory agency,” said Dan Zhang, executive chairman of Chinese CRO Fountain Medical Development Ltd.
“Temporarily, it is a bottleneck in China to have a shortage of talent who really understand a global drug development scheme.”
Hua Medicine Ltd. EVP and CFO George Lin told BioCentury the issue is arguably most pronounced in oncology, where there’s a big need for doctors with experience running clinical trials of