Evaluation of clinical trials following an approval from a research ethics committee

摘要

BACKGROUND AND OBJECTIVE: According to the Medical Association's professional code of conduct a consultation of the responsible ethics committee has to be undertaken prior to biomedical research. Up to date there has been no systematic analysis of published results after an approval from the research ethics committee of the Medical Association Westfalen-Lippe. A measure for the importance are publications of concluded trials. This work presents a comprehensive collection and evaluation of clinical trials that were approved in 1996. METHODS: Clinical trials that were approved by the ethics committee in the year 1996 were analysed concerning their publication parameters, if results have been reported to the ethics committee, the design of the study and their funding. Publications were found by database mining in the Internet sources "Pubmed" and "ISI Web of Knowledge". RESULTS: 70 % out of the 99 approved clinical trials were published as specified in the initial proposal, whereas in 2 % only aspects of the proposal were published. In 21 % of the cases only publications in closely related subjects could be identified. 7 % however remained unpublished. Of these studies 63 % were designed as mono centre study and 37 % as multi centre studies. The time from approval of the study until publication was 46 months (median value). Furthermore the analysis revealed, that 45 % of the studies were funded by industry. CONCLUSION: This work represents an unprecedented and detailed analysis of the clinical studies approved by a German ethics committee. In the course of this work a comprehensive catalogue with criteria to facilitate a collection and tracking mechanism was established. This should enable the ethics committee to comply with their new duties. A great amount of the clinical trials were presented in publications to the scientific community.