Regulatory delays in a multinational clinical stroke trial.
Jeroen C de JongeHendrik ReininkBridget ColamIris AlpersAlfonso CicconeLaszlo CsibaJanika KõrvIwona Kurkowska-JastrzebskaMalcolm R MacleodGeorge NtaiosGötz ThomallaPhilip M BathH Bart van der WorpPublished in: European stroke journal (2021)
In this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials.