Best Practices in Study Feasibility

Successfully navigating the medical, clinical, logistical and regulatory challenges associated with establishing the feasibility of a clinical trial is not easy. Insights from sponsos, contract research organizations (CROs) and sites have been compiled in ISR’s Best Practices in Study Feasibility report. A particular area of interest for readers of the report are the techniques and innovations proffered by sponsors and CROs for conducting feasibility analyses. Both groups identified that the integration of statistical modeling and knowledge of past performance into feasibility analyses is positively impacting the process. 

Sponsors also see value in making direct, personal contact with investigators to build better relationships and a greater use of electronic medical record (EMR) data as positive innovations. CROs point to improved feasibility surveys and better targeting questions as ways to improve study feasibility estimations. ISR also collected insights to improve the accuracy of study feasibility estimates including: the percentage of trials that require a feasibility analysis, and whether the analysis is conducted in-house or outsourced; awareness of feasibility analysis service providers and frequency of use; and the data sources utilized for feasibility analyses and a ranking of which data sources contribute to the accuracy of the estimate.