What does it take to deliver an international neurosurgical trial? Experiences from STICH II.

Background And Purpose: When undertaking multicentre randomised controlled trials some obstacles cause a slower than required recruitment rate. This article discusses factors that affected the completion of the international neurosurgical trial STICH II, which took almost 6 years.

Methods: We reviewed the following factors: recruitment of participating sites, patient recruitment, patient screening, trial fatigue and maintenance of profile and maintenance of quality and standards.

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.