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.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------