Situation: Phase 3 dental trial

The Success: Our project team was able to overcome enrollment obstacles and exceed sponsor expectations. We started the study using all sponsor selected sites. Many of these sites had no previous experience with clinical research, and early on we saw some issues with patient recruitment. Our project team took the following actions to make sure that quality data was collected and enrollment goals and timelines were still met:

• We conducted in-depth GCP training for all sites during the site initiation visits.
• Monitors were on-site during the first study visit where subjects were randomized to answer questions and to make sure study procedures were being followed.
• Based on our recommendation, the sponsor added several high performing sites we had used in the past. These sites exceeded enrollment expectations and routinely outperformed the original sites.
• We surveyed the sites to identify recruitment hurdles and ensure efforts to bolster recruitment were effective and tailored to the sites’ specific issues.
• We held regularly scheduled calls with site study coordinators to share best practices as well as identify and fix issues. We routinely saw spikes in enrollment following the calls.