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.

Clinical Trials Legislation - Preparing for the Revision of the European Directive Scheduled for 2011

“…A recent study [1] illustrates the point of view of European investigators who have authored clinical trials published in major medical journals with regard to the European EC who had given opinions on these studies (table I). Investigators were mostly dissatisfied with both the content (the Committees' expertise and competence) and the form (submission procedures and the quality of the contact).…”

Législation des essais cliniques : préparer la révision de la Directive Européenne prévue en 2011

“…Une étude [1] a montré le ressenti d'investigateurs européens ayant publié des essais cliniques dont ils étaient auteurs dans de grands journaux médicaux vis-à-vis des Comités d'Éthique (CE) européens qui avaient émis un avis sur ces études (tableau I). Tant sur le fond (expertise et compétence des Comités) que sur la forme (procédures de soumission et qualité des contacts) les investigateurs étaient plutôt insatisfaits.…”

Should European Independent Ethics Committees be dismantled?

“…This issue of Intensive Care Medicine presents two aspects of the difficulties that face Independent Ethics Committees (IEC) regarding their role and responsibilities, and not resolved either by the European Directive or by its translation in national laws: a negative point of view on the utility of European IECs through a survey among authors of clinical trials published in some major journals in 2007 [1], and a constructive initiative of the Vienna university IEC, on reviewing interventional studies at minimal risk through an expedited process [2].…”

“…The paper of Pehboeck et al [1] reports the dissatisfaction of 193 authors regarding IECs and clinical trials registers and who have published results of clinical trials in selected major journals in 2007. The negative perception of authors (on a scale from -10 to ?10) is consistent across all five items in terms of support provided by IEC, effort needed to obtain approval, and friendliness of the approval procedure.…”

“…The paper of Pehboeck et al [1] has the merit to raise the crucial question whether IECs are competent for giving ethical and scientific opinions. Indeed, the role of IECs is not to refine continuously the major ethical principles that rule the clinical research.…”