An evidence-based approach to conducting clinical trial feasibility assessments

Author(s): Otis Johnson

Failure to enroll patients is now one of the leading causes of clinical trial delays – and even of trial failures. By using a data-driven approach to determining trial feasibility, drug sponsors can specify with a high degree of confidence exactly how long it will take to fulfill a study’s patient quota. Today, there are rich sources of data that can inform the trial forecast, as well as sophisticated modeling tools to test ‘what if’ scenarios and establish confidence levels for the results. Using these resources, sponsors can accurately forecast enrollment timelines, flag potential risks to the plan and identify variables that can be adjusted to influence the timeline.