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Pretrial Questionnaires May Not be Predictors of Site Performance
Contributed by Sherry Reuter, B.S.N., M.S., Senior Clinical Project Leader, Alexion Pharmaceuticals Inc.

While it is standard procedure to send pretrial questionnaires to choose potential sites, more than 94% of clinical trials in the United States fail to complete on time because of enrollment difficulties. It is evident that the current system is not working. A relatively low-cost way to address this issue is to select the sites most capable of recruiting patients. Companies use the information from pretrial questionnaires, quantify the data, weigh the most important criteria, and rank the different sites to determine the best sites for a particular trial. Unfortunately, the questionnaires currently used may not provide useful data to accurately predict a site’s performance in a specific trial. This could help explain why sites do not meet enrollment timeline goals…