CA SE STUDY NO. 4
STEADY-PD III
Background
STEADY-PD III is an ongoing 36-month, double-blind,
randomized, placebo-controlled study of isradipine in people
with early Parkinson's disease (PD) who, at baseline, were not
receiving symptomatic therapy or expected to require it for at
least three months. The projected recruitment period was 18
months at 57 Parkinson Study Group sites across North America.
Methods
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 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:
+ + STEADY-PD III principal investigators
+ + Site representatives (investigator and/or coordinator)
+ + A representative from The Michael J. Fox Foundation (MJFF)
+ + A representative from the National Institute of Neurological
Disorders and Stroke (NINDS)
+ + Patient advocates
The recruitment committee consulted with national Parkinson’s
disease 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
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Accelerating Clinical Trials: Best Practices for Recruitment and Retention
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 “Health Care Provider Outreach Letter” and a “Patient-
Facing Slide Deck,” facilitated outreach efforts, as did grassroots
peer engagement via MJFF’s Fox Trial Finder Ambassadors, PDF’s
Parkinson’s Advocates in Research (PAIR) and the Muhammad
Ali Foundation’s community leaders. A greater online presence
was cultivated through: 1) creation of a study-specific website
(steadypd3.com); 2) press releases (templates were provided
in the Recruitment and Retention Toolkit) posted to websites
such as NINDS; 3) use of Fox Trial Finder — MJFF’s online trial
matching service that enables volunteers to connect with trial
teams (foxtrialfinder.org); and 4) webinars and podcasts hosted
by the STEADY-PD III study principal investigators and broadcast
to MJFF and NPF networks. 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.
Results
A study enrollment report (Figure 1, opposite page), 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 percent 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 followed by an uptick in traffic
to the STEADY-PD III website (steadypd3.com) that began in
May 2014 and peaked in July 2014 (Figure 2, pg. 22). One of
the steepest peaks occurred in January 2015, after a December