Data source
To strengthen the supervision and management of clinical trials of drugs, promote the openness and transparency of clinical trial information of drugs, protect the rights, interests and safety of subjects, the Medical Products Administration (NMPA) in China has established a web-based database for clinical trials. This is named as the Drug Trial Registration and Information Publication Platform, and was officially released in 2013. It is a national authoritative database of clinical trials in China, and all drug clinical trials being done including phase I to IV trials should be registered and the bioequivalence studies must be registered on the platform before enrolling the first patient. The NMPA then routinely cross-checks the information on the platform with the related data and summary report submitted with a given trial to ensure that the information is accurate and up to date. Retrospective registration is required for trials that started before 2013, but is not completed for the related new drug applications.
Information about the registered drug clinical trial includes sponsor’s information, such as the applicant name, contact information, etc.; trial’s information, such as the name of the drug studying, indications, drug types, study purposes, trial design, subject information, inclusion and exclusion criteria; researcher’s information, ethics committee approval information, trial status, etc. After retrieval, there are 9797 drug clinical trials registered on the platform as of January 9, 2020.