Objective To explore the current problems of training on ethics reviews in clinical trials in China.
Methods We designed a quantitative survey to collect participants’ feedbacks on the training workshop on ethics reviews, which included contents, arrangement and structure, relevant to the workshop and their difficulties on ethics review work.
Results A total of 60 questionnaires were sent and the response rate was 56.7% (34/60). A total of 120 participants from 18 provinces of China. Most of them were members of the virtual research center of evidence-base medicine of the Ministry of education. A total of 78.1% (25/32) participants thought they achieved their purpose after training, and 12.5% (4/32) did not meet their needs due to the poor language. The feedbacks of contents and quality of the workshop on ethics were shown in Table 1. The top useful contents (cents in 8-10) were: clinical trial registration, policies of WHO and China (93.8%, 30/32), data management and quality control in clinical trials, the roles of clinical trial registries and ethics committees (93.3%, 28/30), transparency in clinical trials (93.3%, 28/30), informed consent and beyond (91.8%, 31/34), and how to approach ethical review case studies (90.9%, 30/33), etc. Nobody considered workshop of less help.The majority (85.1%, 23/27) thought difficulties on ethic reviews existed and the main difficulties include: short of operational administrative rules (82.6%, 19/23), poor training opportunity (52.1%, 12/23), less supports from administrative (30.4%, 7/23) and financial (21.7%, 5/23), etc. The relevance (8-10 cents) to ethics workshop was: methods of teaching 75.9% (22/29), PPT 75% (21/28) and materials 42.9% (12/28).
Conclusions There is some limitations in the first workshop on ethic reviews due to the lower response rate. However, it still shows the importance of training on ethics reviews. Training strategies should focus on different participants’ needs and the relevance to methods of teaching, and materials, etc. Workshopadopted lectures, cases studies analysis, more discussions and necessary translation will be welcome.
Citation: WEI Maoling,LI Youping,DENG Shaolin,WU Taixiang. Current Status and Strategies of Training on Ethics Reviews on Clinical Trials in China. Chinese Journal of Evidence-Based Medicine, 2010, 10(7): 828-831. doi: 10.7507/1672-2531.20100502 Copy