Background
Patients rushed to enroll almost as soon as word of the study got out. We were dealing with a significant unmet need: Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists. But there was no approved, effective pharmacologic treatment. And patients desperately wanted one.
Objective
With unanticipated interest in these pivotal Phase 3 studies, Premier Research needed to line up and train the right resources while collaborating effectively with the central laboratory, data manager, and other participants.
Dealing with the unexpected: Surprisingly fast enrollment
Our Strategy
We quickly saw what was happening and geared up to deal with it. With enrollment moving so fast in the U.S., we immediately downsized the European arm of the study. That was the easy part. We had to line up and train the right resources, well beyond our original staffing plan.
We doubled the number of CRAs to 45. We assigned 10 clinical managers. We arranged for strong team members at all levels, so we could divide the tasks and confidently delegate responsibilities.
Equally important, the team collaborated effectively with the central laboratory, data manager, and other participants the sponsor had assigned to the project. Everyone contributed and supported good ideas. It was collaboration all the way. Together, we delivered conclusive, positive results eight months ahead of time, in a study that was originally scheduled to last 19 months.
Takeaway
The results were proof that a CRO of our size – if it’s the right one – can deliver the resources to support even large, parallel global studies like these. In fact, our size likely contributed to our flexibility to keep pace with the unexpected.