Recruitment and Retention in Clinical Trials of Deep Brain Stimulation in Early-Stage Parkinson's Disease: Past Experiences and Future Considerations

K. Grace Cannard, Mallory L. Hacker, Anna Molinari, Lauren E. Heusinkveld, Amanda D. Currie, David Charles
2018 Journal of Parkinson's Disease  
U n c o r r e c t e d A u t h o r P r o o f Journal of Parkinson's Disease xx (20xx) x-xx Abstract. 12 Background: Clinical trials are often hindered by inadequate patient recruitment. Overly optimistic investigator predictions of participation can lead to unmet recruitment goals and costly trial extensions. A patient-focused approach estimating recruitment in clinical trials may provide higher accuracy. 13 14 15 Objective: To predict the feasibility of recruitment in a future deep brain
more » ... e deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) multicenter trial by understanding motivations and concerns to participation of past and potential future DBS in early-stage PD clinical trial subjects. 16 17 18 Methods: To identify motivating factors and barriers influencing trial participation, an end-of-trial survey was administered to subjects enrolled in a DBS in early-stage PD pilot trial with subjects randomized to receive DBS plus optimal drug therapy (DBS+ODT) or ODT alone (NCT#00282152, IDE#G050016). Pilot trial survey results were analyzed in conjunction with results of a previously-reported survey querying patients with early-stage PD about potential participation in a trial for DBS in early-stage PD with similar inclusion/exclusion criteria. 19 20 21 22 23 Results: Pilot trial subjects reported high levels of satisfaction with their participation in the trial. Similar motivations and barriers to participation were expressed in comparable proportions by subjects who successfully completed the pilot trial and patients with PD considering enrollment in a comparable study. 24 25 26 Conclusions: The FDA has approved a prospective, randomized, double-blind, phase III, multicenter, pivotal clinical trial evaluating DBS in early-stage PD (IDE#G050016). These results suggest that the successful recruitment and retention of early-stage PD subjects, as observed in the pilot trial, is attainable in a future pivotal trial. 27 28 29
doi:10.3233/jpd-181381 pmid:30010145 fatcat:xvj2xt3g5nh2bgfl7n3olkzlly