ABSTRACT
Objective To reveal the average pass rate of a general hospital's ethic review and common problems.Methods The records generated by the ethics committee of a hospital in 3 consecutive years were reviewed and analysed with ridit of CMH and Bootstrap statistical methods.Results The pass rate for drug clinical trial is 36.09%,medical instruments 18.42%,and subject evaluation 14.29%.Among the problems,those concerning informed consent take up 63.59%,of protocol 14.56%,of CRF 7.77% and of the others 22.820%.The domestic applicants had more problems than those abroad.Besides,the pass rate of drug trials decreased with year from 45.83% in 2006 to 19.44% in 2008,which was statistically significant (P=0.029).In terms of drug clinical trial,the pass rate of revised projects in foreign countries was significantly higher than the domestic ones (P=0.028).ConclusionEthics Committee in a hospital plays a very important role in clinical researches.And informed consent and research protocol are very important in the ethic review.
ABSTRACT
Objective To evaluate the reasonability and feasibility of evaluation index system for the Capital Research Fund for Medical Development in order to provide some preliminary practical and theo-retical fundamentals for setting up and improving an evaluation index system for the Capital Research Foun-dation for Medical Development. Methods Based on the investigation of thirty three hospital's administra-tors in Beijing,we used statistical methods to evaluate the reliability and validity of the evaluation index sys-tem. Results The first grade and second grade index were approved by more than 87.88% responders;the half-reliability of the evaluation index system was 0.7933 and the Cronbach's alpha coefficient is 0.9103, the factor analysis of the second grade indicators showed that there were four factors extracted, and the accu-mulative variance reached 78.44%. Conclusion The evaluation index system for the Capital Research Fund for Medical Development is reasonable and feasible,and the research result will provide a basis for fur-ther study.