Medisch-ethische toetsing van multicentrisch onderzoek kan sneller

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.

Conflict of interest: none declared. Financial support: none declared.