Examining the clinical trial feasibility process and its implications for a trial site

mining the clinical trial feasibility process and its implications for a trial site Original Research (3567) Total Article Views Authors: Burgess LJ, Sulzer NU Published Date September 2011 Volume 2011:3 Pages 51 - 54 DOI: http://dx.doi.org/10.2147/OAJCT.S23631 LJ Burgess, NU Sulzer TREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South Africa Objectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved. Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data. Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months). Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.