In a systematic review published this week in Trials, Simpson and colleagues investigate techniques and interventions to reduce inappropriate enrollment of patients into clinical trials. Key
eligibility criteria ensure the exclusion of patients likely to be harmed by treatments,
and enrollment of patients in violation of these criteria can result in
avoidable harm including serious adverse events and death.
systematic review of techniques and interventions for improving
adherence to inclusion and exclusion criteria during enrolment into
randomised controlled trials
Fiona Simpson, Elizabeth A Sweetman, Gordon S Doig
Trials 2010, 11:17 (23 February 2010)
[Abstract] [Provisional PDF]
A search of the literature uncovered only one abstract describing an intervention designed to reduce enrollment error – a dummy enrollment run-in phase that was found to be effective in reducing inappropriate enrollment during the actual clinical trial. As a first step to addressing the paucity of literature on this topic, Simpson et al recommend that authors report all protocol violations, including non-adherence to inclusion and exclusion criteria, within the primary results paper. However, given the serious potential implications, it is hard to ignore the authors’ call for more research to identify and validate new techniques to reduce enrollment error.