[Medical-ethical review of multicenter studies can be obtained faster: new directive leaves room for improvement]. / Medisch-ethische toetsing van multicentrisch onderzoek kan sneller: nieuwe richtlijn biedt ruimte voor verbetering.

ABSTRACT

OBJECTIVE: To evaluate whether the speed at which multicenter studies can be launched in the Netherlands has been improved by the new External Review Directive. DESIGN: Cohort study. METHOD: We studied the time between requesting and granting a declaration of local feasibility of 7 multicenter studies under the new External Review Directive, which came into effect on 1 March 2012. We distinguished between centres that complied with the new directive and those that did not. We also compared the time to approval of local feasibility of these 7 studies with those of 13 studies that were launched under the old directive. RESULTS: Under the new procedure, the median time between issue of the approval letter by the primary evaluative centre and approval by the Board of Directors of the participating centre was 93 days 50 days for centres that performed the procedure in accordance with the directive (31 applications) and 118 days for centres that did not perform the review in accordance with the new directive (79 applications). This difference was significant (log rank test; p = 0.003). Under the old procedure, the median time to approval was 103 days (336 applications). CONCLUSION: The new External Review Directive for multicenter studies provides a significant improvement in time to approval of local feasibility for multicenter trials in centres that commit to the new directive. However, the majority of hospitals have not yet complied with this directive, which still delays studies unnecessarily.