Abstract 3192: A Descriptive Study of Interventional Management of Stroke III Trial Investigator Recruitment Enhancement Strategies

Abstract

Purpose: Randomized control trials (RCT) are the gold standard of clinical research, yet most RCTs do not finish on time or on budget of the original proposal. The literature lacks research relevant to enhancing investigator recruitment strategies. Therefore, we sought to explore the role of these strategies in the ongoing NIH-funded, Interventional Management of Stroke (IMS) Phase III Trial. Method: We limited this analysis to November 1, 2007 - July 31, 2011 to exclude the start-up period for the trial. We compiled the dates of all potential recruitment enhancing strategies used in the trial, including investigator meetings, contests to reward recruitment, amendments to broaden eligibility criteria, and the addition of more sites in the US and internationally. We compared mean enrollment in the two months immediately before and after the month of intervention, and prespecified that an enrollment change of ≥ 25% would be considered a potentially effective recruitment strategy. Given the limited variability, only descriptive analyses were performed. Results: From November 2007 through July 2011, the mean monthly recruitment in the IMS III Trial was 9.77, ( SD = 3.2) subjects and the range was 4-20. There was no significant change in recruitment rates over time ( p = 0.56). We identified a change of ≥ 25% after each investigators’ meeting at the International Stroke Conference in 2008, 2009, 2010, and 2011. Other interventions that exceeded the 25% change were the submission of Amendment 3 (Jan 2009), conduct of an investigators’ conference call (Aug 2010), and initiation of screening at European sites (Mar 2011). See Table 1. Discussion: Investigators’ meetings and/or the International Stroke Conference appeared to increase enrollment significantly in the IMS III Trial. We speculate that these investigators’ meetings convey the commitment of the PI and administrative staff and increase the enthusiasm of investigators to complete the study. Additional efforts may have been beneficial, but our analysis was limited by multiple confounding factors, including the imprecision of the timing for implementation of some strategies as with IRB-approval of new amendments at each institution, and individual site factors such as the probation of underachieving sites. Review of the literature identified online education pertaining to consent methodology as a new avenue for the IMS III Trial to explore to maintain recruitment. Further evidence-based study of methods to improve investigator-initiated recruitment is needed. Table 1: Recruitment Efforts and Corresponding Monthly Enrollment Rates