Troubleshooting an Under-Performing GI Trial

Situation

A global pharmaceutical company was experiencing significant recruitment challenges in a priority Phase III gastroenterology trial, as competitors were running concurrent studies in the same patient population. Site activation was significantly below expectations for this type of trial, and the CRO was proposing to add further sites – despite resources spread thin and with budgets under pressure. The company brought Phesi in to identify viable solutions.

Analysis

Phesi used its real-time, comprehensive database to quantify the level of competition geographically. This confirmed that many of the chosen sites were in highly competitive locations for similar trials and patients. Phesi identified 17 comparable historical trials (mostly Phase III), with similar designs and number of patients. Using these as a benchmark, we agreed with the client on realistic and feasible site activation rates, patient enrollment rates, and enrollment cycle time. Our data guided a targeted action plan to get the trial on track.

imgSolution

Phesi counselled the client to close poor-performing sites and focus on fewer but higher performing sites, and not add new ones recommended by the CRO. Phesi worked with the trial sponsor and the CRO to align on an achievable plan to complete the trial. Enrollment completed on the exact date that Phesi predicted.

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