Submission of clinical studies to ethics committees or clinical trials registers: the authors’ point of view

Abstract

To evaluate the satisfaction of clinical scientists when submitting study drafts to an ethics committee/clinical trials register (CLINICALTRIALS, EUDRACT, ISRCTN) we conducted an online survey of 240 authors publishing in anesthesia/critical care medicine (A) or in major general medical (M) journals from January to December 2007. No statistical difference between groups A and M was seen with regard to the number of studies submitted to ethics committees or registered in various clinical trials registers. On a visual analogue scale (VAS −10 to +10), the subjective evaluation of the effort required to submit a study draft to an ethics committee or enter it in a clinical trials register produced almost only negative grades in both groups. The mean different perceptions ranged from −3.5 to −0.1 in group A and from −4.4 to −0.2 (except for +0.1 and 1.9 in 2 subgroups) in group M. The authors in both groups gave a positive score to the better transparency in scientific research resulting from introduction of the clinical trials registers (+2.4 in group A, +4.8 in group M). The results of our study indicate widespread author dissatisfaction when submitting a clinical trial to ethics committees or clinical trials registers.

Appendix

See Table 1.

Table 1 PubMed search terms used for retrieval and selection of papers