China DCT Regulation and Implementation 

August, 2023 - Yang (Aaron) Gu, Pengfei YOU, Duzhiyun ZHENG, Fengqi YU

The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients. Decentralized Clinical Trials ("DCT") are a new type of clinical trial that embodies the "patient-centered" concept, providing new solutions and motivation for drug R&D activities for marketing registration purposes. According to the latest Technical Guidelines for the Implementation of Patient-Centered Drug Clinical Trials (for Trial Implementation) ("Technical Guidelines for Implementation") released by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") on July 27, 2023, DCT refers to a new patient-centered clinical trial model, the implementation of which is not limited to the traditional on-site clinical trials. In simple terms, usually, DCT would be conducted using telemedicine as well as mobile or local medical care, allowing clinical trials to take place remotely while the subjects can remain at home.


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