Decentralized clinical trials in China are growing due to a variety of reasons. First, China is a large geographic area (the same geographic size as the US) where most advanced medical research is concentrated in its big cities. However, many patients find it difficult to travel. Second, more privacy requirements and enforcement, supported by the Personal Information Protection Law, also make DCT more viable. Finally, with almost 75% of the Chinese population on the Internet, China has a very robust digital environment.
Despite these advantages, challenges for DCT exist in China today. A major concern involves risk management and compliance concerns for trial sponsors, investigators, and DCT service providers. In addition, the following factors are still evolving including – training for DCTs, information sharing between local hospitals and secure databases, electronic data capture, eConsent, etc.
Written by: Ames Gross – President and Founder
Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://globalforum.diaglobal.org/issue/december-2022/decentralized-and-digitalized-patient-centric-dcts-in-china/