Applied Clinical Trials
A case study of a Parkinson’s disease trial demonstrates how one study team met its enrollment goals.
The Michael J. Fox Foundation for Parkinson’s Research (MJFF) aims to speed clinical research by removing obstacles that stand in the way of drug development. In pursuit of this mission, the Foundation gathers insights from a wide range of stakeholders and uses these perspectives to enhance clinical trial processes from start to finish. In Applied Clinical Trials’ Eye on Patient Advocacy series, we will share best practices and lessons learned from the field of Parkinson’s research that can be applied to clinical trials across disease states. In our second column in the series, we explore how one study team implemented a multimodal recruitment strategy to meet their target enrollment six months ahead of schedule.
STEADY-PD III was a 36-month, double-blind, randomized, placebo-controlled study of isradipine, a repurposed antihypertensive drug, in people with early Parkinson’s disease (PD). The projected recruitment period was 18 months at 57 academic research sites across North America.
Participants and procedures
STEADY-PD III aimed to enroll 336 men and women with early-stage idiopathic PD. Participants had to be older than 30 at the time of diagnosis, diagnosed less than three years prior, and not receiving PD symptomatic therapy (e.g., levodopa, dopamine agonist or MAO-B inhibitor) or projected to require symptomatic therapy for at least three months from baseline visit. To participate in the study, eligible participants agreed to be followed for up to 36 months and complete 12 in-person visits and four telephone visits. The projected recruitment period of 18 months was based on previously completed studies that targeted a similar PD population.
Forming a recruitment committee
Early in the planning process, the STEADY-PD III team identified and engaged key stakeholders from across the recruitment landscape to provide input on constituent motivations, knowledge gaps, and outreach methods. This group, the recruitment committee, consisted of:
The recruitment committee consulted with other national PD organizations, including the National Parkinson Foundation (NPF) and the Parkinson Disease Foundation (PDF), which have since merged to form the Parkinson’s Foundation.
With this guidance, the committee developed a multi-modal recruitment strategy aimed at educating individuals in the PD community about STEADY-PD III and increasing awareness of resources related to the trial. This strategy was implemented through 1) in-person meetings and events with community groups, physician networks, and support groups; and 2) development of a heightened online presence using mixed media outlets. MJFF’s Recruitment and Retention Toolkit materials, such as a “Physician Referral Letter” and a “Patient-Facing Slide Deck,” facilitated outreach efforts, as did grassroots patient engagement through patient organizations.
A greater online presence was cultivated through 1) creation of a study-specific website (steadypd3.com); 2) press releases (templates were provided to sites) posted to websites such as NINDS; 3) use of Fox Trial Finder-MJFF’s online trial matching service that enables the Parkinson’s community to connect with trial teams (foxtrialfinder.org); and 4) webinars and podcasts hosted by the STEADY-PD III study principal investigators and broadcast to the networks of patient organizations. Throughout the enrollment period, the recruitment committee met monthly to review recruitment strategies, monitor enrollment at the study and site level, and identify challenges and solutions to any recruitment issues.
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A study enrollment report (see Figure 1 above), generated after all participants had been recruited, shows a steeper slope of actual vs. anticipated enrollment, reflecting a recruitment period accelerated by six months. In addition, the pre-specified goal of 10% minority recruitment was met. Analysis of MJFF communications that took place prior to and throughout the recruitment period provides insight into the role of mixed media in generating awareness of the trial and directing individuals to resources for learning more about participation. In March 2014, MJFF, with study leadership, released a podcast that reported isradipine was moving to Phase III testing, and recruitment would begin later that same year. The podcast was downloaded by 2,043 iTunes listeners. This was
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followed by an uptick in traffic to the STEADY-PD III website that began in May 2014 and peaked in July 2014 (see Figure 2; click to enlarge). One of the steepest peaks occurred in January 2015, after a December 2014 MJFF webinar that focused on therapies with the potential to slow or stop Parkinson’s progression and highlighted the STEADY-PD III trial. A third peak took place in November 2015, after an October 2015 MJFF webinar and podcast on studies to slow or stop PD.
A multitude of subject referral sources bolstered STEADY-PD III recruitment success (see Figure 3; click to enlarge).
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Referral sources were recorded at the time of screening and logged into case report forms. These data indicate the top four referral sources were site personnel (53%); neurologists (24%); Fox Trial Finder (10.2%); and MJFF communications (3.9%).
By having a comprehensive recruitment plan and involving key stakeholders early in the planning phase of the clinical trial, STEADY-PD III was able to successfully recruit its full target population six months ahead of schedule. They identified study- and site-level barriers that had the potential to negatively impact recruitment, and were able to develop a strategy to mitigate them. One important component of that strategy was implementation of a comprehensive outreach and awareness campaign. Patient engagement via advocacy organizations; local events including the Brain and Health Fair and the annual Parkinson’s Unity Walk; the power of digital media through webinars and press releases; technology such as Fox Trial Finder to connect volunteers to trial teams; and increased participation of historically underrepresented minority populations with community engagement, translation of materials, and outreach through local publications such as the “Southwestern Parkinson’s Newsletter.” The use of local grassroots events and digital media activities, combined with a proactive approach to recruitment, helped to engage and make aware a broader population than would have been possible for clinical trial sites alone. This approach also enabled study teams to connect with a more diverse population of patients who obtained their information from a variety of media and news sources. While the impact of these efforts is somewhat challenged by self-reported referral source data (see Figure 3), we posit that this is less about the efficacy of these efforts and more about challenges stemming from memory recall bias in referral source attribution. Greater efforts such as interviewer training, better referral source definition, and alternative means of data collection should be considered for future recruitment campaigns to improve the accuracy of attribution.¹
1. E Hassan. “Recall Bias can be a Threat to Retrospective and Prospective Research Designs.” The Internet Journal of Epidemiology. 2005 3(2)
Bernadette Siddiqi, MA, is an Associate Director on the Recruitment and Retention team at The Michael J. Fox Foundation for Parkinson’s Research. To contact the MJFF Recruitment and Retention Team, email: email@example.com.
MJFF would like to acknowledge the following individuals for their contribution to the research presented in this case study: Sarah Berk, MPH; Kevin Biglan, MD, MPH; Brittany L. Greco; Robert G. Holloway, MD, MPH; Catherine M. Kopil, PhD; Claire Meunier, MBA; and Tanya Simuni, MD