[Review of multicentre clinical trials is simplified; more trial centres are approved in the first assessment round]. / Toetsing multicentrisch onderzoek is vereenvoudigd.

ABSTRACT

The CCMO (the Dutch Central Committee on Research Involving Human Subjects) has evaluated the External Review Directive. This new directive for multicentre clinical trials reduces the administrative burden in approving medical research involving human subjects. The number of trial centres approved in the primary decision has increased. However, it still takes quite some time before a study actually starts. The boards of directors of the participating trial centres play an important role in further streamlining the process.