Since the public clinical trial registration system was launched twelve years ago in China, as the primary register of the WHO International Clinical Trial Registry, the Chinese Clinical Trial Registry (ChiCTR) has largely promoted the development of clinical trial registration in China, particularly in recent three years. The quantity of registered trials has increased rapidly and 3939 studies were registered in ChiCTR in 2017. An increasing number of investigators, Institutional Review Boarders and funding agencies were taking the trial registration into account in the medical research ethics issues these years. Considering the large number of workforce in public health, limited researchers knew clinical trial registration very well, even with misunderstandings. For instance most of them do not know the purpose of trial registration and the principle of local registration. A lot of Chinese medical journals editors have been working together with us to promote the development of clinical trial transparency in last ten years, and they have made outstanding contributions. We would like to appeal more medical journals to join the great revolution of medical research.
Objectives To explore potential important factors that impacts the quality of Chinese trials. Methods We randomly selected clinical studies registered in the Chinese Clinical Trial Registry during March 15th, 2016 to December 31st, 2016. The randomized controlled trials protocols were retrieved to assess the quality based on the SPIRIT guideline, their data management plan and statement of sharing individual participant data were also investigated. Results 457 studies were randomly selected from 2 205 studies by a rate of 1∶4. Among them, 393 were randomized controlled trials. Pre-market trials of new medicines conducted by the State Clinical Study Bases had better quality of protocols. In total, 4 protocols were rated as high quality (1.02%) and 21 as higher quality (5.34%). 129 studies in 457 (28.23%) described a correct data management system including a paper case record form and an electronic data capture. 392 studies (85.77%) stated that public sharing IPD will be available. Conclusions Poorly developed protocol and lack of professional data management system are common issues in some Chinese clinical studies. We feel confident that most Chinese investigators are good in learning considering that they are willing to share the IPD of their studies. Providing education and technical support focus on three technical aspects are crucial: introducing SPIRIT for developing protocol, providing standardized data management system, and introducing the concept of transparency include sharing IPD which is an essential requirement of clinical study ethics.