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.