Persistence Leads To High Enrollment: PRA Convinces Client To Stick With Recruitment Strategies

PRA was contracted by a large biotech client to evaluate the immunogenicity of a flu vaccine in adult subjects with rheumatoid arthritis. Early on, PRA realized the potentials for study delays and so began discussing recruitment planning strategies with the client.

From the start, the PRA study team faced a shortened enrollment period and other timeline challenges, including the protocol’s late delivery as well as problems with the vaccine’s availability. The study team realized that the shortened enrollment period would limit the number of patients eligible for recruitment, because many would have had already received their seasonal flu and/or H1N1 vaccinations. In addition, the client resisted PRA’s initial attempts to discuss and implement recruitment planning strategies.

The project team utilized PRA’s Project Management Methodology, which supports project teams in every project-related objective, and our Service Delivery Model, with its focus on delivery and service, to ensure the successful execution of this project. PRA held weekly recruitment planning discussions with the client, presenting graphs that demonstrated how October and November could produce solid screening results. At the end of October, PRA implemented a weekly e-mail blast to sites providing updates on enrollment and other hot topics. By November, PRA convinced the client to allow us to request sites to forecast their screening activity for the next four weeks. This effort proved that the sites were not hitting their goals. Therefore, we used that information to get the client to approve additional strategies to help sustain recruitment.