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. We discuss the practical strategies employed by the STICH II team to address these factors and optimise patient recruitment. CONCLUSION: Although STICH II attained its final recruitment target, it took longer to complete than anticipated. Publishing and sharing the experiences of the STICH II trial team is an important step towards ensuring that other potential neurosurgical triallists are aware of the issues that can slow patient recruitment and strategies that can help to overcome them.

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.