Successful Operational Strategy Met Aggressive Enrollment Timelines

Case Study

Upon receiving an unexpected approval for an anti-hypertensive investigational drug, the sponsor contacted PPD to conduct a study to collect additional safety data. Compounding the need to get up and running quickly was the high volume of participants—more than 25,000 patients at 3,000 sites across 12 countries. The project had aggressive timelines; most notably was a six-month enrollment period. With a focused media campaign, dedicated study start-up teams and centralized management of recruitment and monitoring, PPD had sites activated within three months (compared to a typical timeline of six to nine months for global studies).

PPD’s operational strategy included the following elements:

Study start-up teams: Four dedicated teams provided valuable efficiencies by focusing on specific tasks of the study start-up process (specific team tasks included collecting regulatory documents, contract negotiations and site agreements as well as coordinating drug shipment eligibility and site training). Within three months, PPD’s efforts resulted in 3,539 qualified sites, 2,448 IRB approvals and 2,070 received drugs.

Targeted monitoring: Using a simplified case report form, reduced source document verification and centralized targeted monitoring,* PPD significantly reduced the logistical burden of site visits and data processing, while providing a cost-effective site management solution.

Media: In North America, a broad-reaching media campaign included television, radio, newspaper, direct response and physician outreach materials. PPD’s call center received 70,000+ inquiries, yielding 34,500 referred subjects to sites resulting in the enrollment of 5,000 subjects.

As a result of these approaches, the enrollment period was completed in a record-breaking four months. The entire study was completed in less than 15 months, providing the client with the right supplemental safety data for re-submission.

* A monitoring model that features fewer on-site visits when compared to a traditional Phase II/III monitoring schedule. Using an algorithm to determine which sites to visit and when they should occur, approximately 10-20 % receive on-site visits. The remainder receive visits via remote telephone-based monitoring from in-house CRAs.