Regulatory Open Forum

 View Only
  • 1.  China Embraces Decentralized Clinical Trials (DCT)

    Posted 13-Sep-2023 16:23

    China's Center for Drug Evaluation (CDE) issued new guidelines in late July supporting the use of DCT via telemedicine to allow clinical trials to be done remotely. The DCT guidelines may be implemented as long as investigators and sponsors agree and the guidelines are clearly outlined in trial protocols and follow Chinese Good Clinical Practice (GCP) and ICH standards. Unlike typical clinical trials where informed consent is disclosed and discussed with patients in person, and a hand copy consent form is signed, with DCT an electronic informed consent is acceptable.

    The Guidelines also highlight other key points. First, telemedicine services must be performed in a quality manner by Chinese doctors. Online Rx drugs can only be written by doctors with confirmation by pharmacists. Second, during DCT, patient information including the management of data, adverse events, etc. must be kept confidential. Third, the Guidelines present specific conditions for the training of patients and ongoing transmission of information between all parties.

    Ames Gross
    Pacific Bridge Medical
    Bethesda, MD

  • 2.  RE: China Embraces Decentralized Clinical Trials (DCT)

    Posted 14-Sep-2023 09:26

    Thank you for sharing this information, it is very interesting to hear about more countries who are publishing decentralized trial guidance.  Would you happen to have a link to the China guidelines that you would be willing to share?

    Frances Smith
    Regulatory Compliance Manager
    Souderton PA
    United States