At a Glance
To ensure one of our longtime clients’ IBD studies stood out in an increasingly competitive landscape, we drew on our database of more than 4,000 GI sites in 50+ countries to find the geo-mix that worked for them. We created a three-step early engagement campaign, including investigator letters, one-to-one calls, and webinars. Within four weeks, we’d collected 170 CDAs and 150 completed e-questionnaires from 20 countries. This early engagement paid off, helping complete enrollment two months ahead of schedule.
Phase 2 IBD Study
Sponsor Challenges
Over the last decade, the number of ongoing IBD trials has gone up considerably due to a rise in the number of trials initiated per year and an increase in trial duration. Heavy competition carries inherent risks in site and patient motivation. As a result, average enrollment rates have plummeted, and many IBD studies have experienced delays.
Steps for Engaging Sites Early
PSI worked with the sponsor to put together a 3-step early engagement campaign:
1) “Dear Investigator…” letter
We developed an engaging “Dear Investigator” letter for potential sites sent with the CDA. This letter introduced:
- The sponsor, including the specific team members managing this study
- The investigational product
- The study design with clear charts and other visual aids
- Highlights of the study’s key differentiators, such as a long-term extension
2) Reaching out to KOLs
PSI organized one-to-one calls between the sponsor’s representatives and select IBD investigators and key opinion leaders in each of the countries considered for the study. These calls served to further promote the protocol and get specific local insight on the study design and logistics.
3) Webinar Campaign
PSI and the sponsor hosted a series of webinars to offer any interested sites a detailed early look at this study. Thanks to our efforts in Steps 1 and 2, 70% of the invited investigators decided to attend at least one of the sessions.
Results
- 170 CDAs and 150 completed e-questionnaires from 20 countries received in 4 weeks
- Enrollment rate 90% higher than industry average
- 240 patients randomized two months ahead of schedule
Learn how PSI can support your GI study at the resources below or contact us today.
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Putting the Focus Back on Site Relationships in Clinical Trials
Solid site relationships are the backbone of successful clinical trials. Learn how PSI overcomes the challenges of successful site relationship management.
