Obtaining regulatory approval for multicentre randomised controlled trials: experiences in the STICH II trial.

BACKGROUND AND PURPOSE

Centres wishing to participate in international multicentre randomised controlled surgical trials such as STICH II (Surgical Trial in Lobar Intracerebral Haemorrhage) have to go through a number of regulatory hurdles. These depend on the nature of the study. In surgical studies, there is a need to obtain ethical approval and individual hospital approval including fully executing contracts between the host organisation and each institution. Firsthand experience has been gained in STICH II by guiding over 80 hospitals through this process in over 20 different countries worldwide.

METHODS

This article examines the administrative challenges of setting up the STICH II trial which include the time that it has taken for each hospital to obtain ethical approval, sign the study agreement and become a fully registered site. The aim of this article is to inform potential triallists planning multinational surgical trials about the potential delays and difficulties that may be encountered in the hope that it will encourage the medical research community to simplify administrative systems. We also hope to influence trial funders to build in 'start up periods' for new studies so that they can get up and running in a realistic time frame. The difficulties which were faced will be highlighted so that the organisers of other randomised controlled surgical trials can be aware of these delays.

CONCLUSION

From the experiences in this trial, it can be concluded that delays will be experienced in obtaining ethical approval and in agreeing on site contracts.