At a Glance
Competition for inflammatory bowel disease (IBD) studies is extremely fierce, with multiple approved standard-of-care options and therapies. For the sponsor of one of the largest-ever global IBD trials, that meant the patient recruitment and retention strategy was key. PSI leveraged our in-house patient recruitment expertise, team continuity, meaningful patient-and-site-facing materials, and an effective digital patient recruitment campaign to meet a challenging enrollment goal of 600 patients three months ahead of schedule.
Sponsor Challenges
With PSI responsible for recruitment in over 40 countries, navigating the different healthcare systems of individual countries was essential to avoid delays in referrals to sites and pre-screening appointments of potentially eligible patients. Busy sites faced a multitude of challenges at the local level, including staffing constraints, lack of training in patient recruitment initiatives, little insight into online digital patient recruitment campaigns, and lack of awareness among patients of a clinical trial in IBD as a possible option.
1. In-House Patient Recruitment Expertise
PSI used a variety of recruitment initiatives to provide broader education among patients, helping them make enrollment decisions, and among healthcare providers and site teams, communicating key information about complex inclusion-exclusion criteria and other protocol details to increase the number of patients screened.
Our teams worked closely with sites managing the online recruitment campaigns. We more easily leveraged detailed information about patient journeys and how different these are by individual countries. We could understand more clearly how patients face challenges, depending on the country, such as accessing electronic medical records. Patients also have different accessibility to diagnostics, treatments, and clinical trials.
2. Collaboration with PAGs
Patient advocacy groups play an influential role in driving awareness of the needs of patients with IBD. We worked with these groups to develop online eligibility questionnaires, site locator maps, and answers to frequently asked questions. We also supported other initiatives, including:
- Developing magazine articles with links to the study website
- Conducting interviews with Key Opinion Leaders
- Providing information flyers and study brochures at charity walks
- Working with GI referral networks to create newsletters and medical press publications and promote the study at GI meetings.
3. Effective Digital Recruitment
PSI worked closely with our preferred vendors and those of the sponsor to develop study websites using search engine optimization and keyword analytics for each of the key enrollment regions. Patients could complete an online pre-screening questionnaire and, if prequalified, be directed to an independent referral specialist for further qualification before being referred to a site. The study websites were optimized using digital advertising and social media.
Constant communication with local CRAs was key to knowing the status of patients and answering questions at sites. Monitoring the site management plan closely, we ensured the online digital patient recruitment service provided more patients for screening and enrollment than the site would have access to otherwise.
Program Successes and Outcomes
- 25% randomization rate for all screenings from digital referrals.
- 1.25 months of global recruitment time saved due to digital campaigns.
- Majority of sites said they would use the digital service again in a follow-up survey.
Learn how PSI can support your pivotal IBD study at the resources below or contact us today
About Us
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