A randomized recruitment intervention trial in Parkinson%26apos;s disease to increase participant diversity: early stopping for lack of efficacy

作者：Tilley Barbara C^*; Mainous Arch G III; Elm Jordan J; Pickelsimer Elisabeth; Soderstrom Lea H; Ford Marvella E; Diaz Vanessa A; Siminoff Laura A; Burau Keith; Smith Daniel W

来源：Clinical Trials, 2012, 9(2): 188-197.

DOI：10.1177/1740774512436881

Background Failure to include participants of diverse race and ethnicity (i.e. those other than European Caucasian, non-Hispanic) in clinical trials impedes the safe development of new therapies given the potential for racial/ethnicity-related variations in treatment response. Increasing diversity is problematic for low prevalence diseases, where most community-based approaches do not reach those with the disease. %26lt;br%26gt;Purpose Increase racial/ethnic diversity of participants in a Parkinson%26apos;s disease therapeutic trial. %26lt;br%26gt;Methods We incorporated a randomized Ancillary Trial into the multisite National Institute of Neurologic Disorders and Stroke Exploratory Trials in Parkinson%26apos;s Disease Long-Term Study 1. Movement disorders clinics already participating in long-term trial 1 were eligible and were the unit of randomization and analysis. At least 14% of adult residents over age 55 and living within 30 miles of the eligible site were from a diverse population, or there was a near-by zip code with a highly diverse population. Eligible sites also agreed to be randomized. The intervention was designed to increase community physicians%26apos; trust in long-term trial 1 investigators and address recruitment barriers in diverse populations. Primary outcomes included percentage of participants from diverse racial/ethnic groups enrolled in long-term trial 1, and qualitative findings from key informant interviews of the Ancillary Trial investigators and coordinators at the end of the trial. %26lt;br%26gt;Results The Ancillary Trial stopped early for lack of efficacy, conditional power less than 1%. The 17 intervention sites had 12.6% diverse participants compared to 15.6% in 15 control clinics; odds ratio 0.82 (95% confidence interval = 0.32-2.16). In key informant interviews, high enrollers of diverse participants reported more use of existing physician relationships, untargeted community outreach, and extensive efforts to overcome participants%26apos; barriers. Low enrollers reported more use of patients in their practices and placed more responsibility for low enrollment on prospective participants.

• 出版日期2012-4