Case Study: Pediatric Migraine
Objectives
PAREXEL was contracted by a major pharmaceutical company to conduct a clinical trial in the area of central nervous system with a pediatric population between the ages of 6-17. 172 sites were initiated in North America. The enrollment period was 10 months in duration, beginning during the 2009 holiday season.
Challenges
The decision to participate in a clinical trial or not can be a difficult decision for any individual, but when a person is making the decision on behalf of their child, concerns over the potential risks of participating are amplified. Also confounding the difficult recruitment scenario was that enrollment targets were fixed as the drug patent was due to expire.
Solutions
A three-pronged strategy was developed to undertake the challenges presented:
- Implementation of PAREXEL Predict, specifically Part B, where sites are asked to build a subject cohort from the clinic’s existing patient database prior to initiation, and subsequently contact for interest and screening, upon initiation.
- A centralized, direct to patient outreach campaign utilizing TV advertising, online promotion and targeted email outreach to supplement gaps in sites’ databases or unforeseen circumstances.
- Professionally developed recruitment tools, produced and distributed to patients/caregivers and staff such as; posters, brochures, DVDs and visit by visit guides, to increase study awareness, facilitate study-related conversation and aid in study conduct.
Outcome
PAREXEL exceeded last patient in enrollment goals by seven weeks and came in under budget. Predict Results: Over half of the sites (61%) completed the Predict process while nearly a quarter (22%) completed a Site Exception Form (See figure 1). This form is used for sites that are dedicated research sites who do not treat patients outside of a clinical research study. The site must document a specific plan for obtaining patients for the study.
Seventy-three percent of sites who completed Predict met or exceeded their planned enrollment goals based on their patient cohort build. In other words, a reasonably accurate projection of a site’s actual enrollment could be made from the initial patient cohort they presented at initiation(See figure 2).
Non-Predict sites demonstrated the common industry average of non-enrolling sites (31%) while only 12% of sites that completed the Predict exercise were non-enrollers. Additionally, 28% of Predict sites contributed 6+ patients versus 10% and 19% of non-Predict and Site Exception Form sites, respectively (See figure 3).
By employing Predict we were able to better manage enrollment by knowing early which sites had ample patients to screen and which were going to need supplemental assistance.
Outreach Results: The outreach campaign yielded favorable results with 1,064 referrals to sites and 167 enrolled subjects, exceeding that industry average conversion rate and meeting the budget parameters for cost per enrolled subject.
The implementation of thoughtful site selection incorporating the demonstration of access to patients combined with professionally developed tools and targeted outreach to account for spontaneous deficits, to enabled
this study to enroll seven weeks ahead of schedule.
What is Predict?
PAREXEL Predict is a methodology to assist in selecting the best sites for a protocol, capitalize on potential cost savings, Predict potential randomization, and meet or exceed enrolment timelines.
If you are interested in learning more about PAREXEL Predict, and how Predict can positively impact your project, please contact: info@PAREXEL.com