Cardiovascular Study Protocol Feasibility

Situation

Phesi’s client was designing and planning a Phase II study for a unique cardiovascular (CV) indication. Its compound was first in class, and the first to target a particular CV dysfunction. The client requested insights from similar historical studies to consider what may impact trial operational performance.

Analysis

Phesi selected 37 trials from its comprehensive clinical trial database, with comparable design and targeting similar patient populations (excluding observational, surgical, ancillary trials and prematurely terminated trials). Phesi experts found that screen-failure rates would be significant, and predicted how many patients should be screened to achieve target recruitment numbers. Phesi also assessed the inclusion and exclusion criteria to ensure the protocol was feasible, and to quantify the impact on enrollment.

Solution

Phesi identified a predictable relationship between the number of sites and the rate of enrollment, showing that 60 patients could be recruited from five sites over 28 months. Based on the homogeneity of the patient population, availability of patients and experienced investigators, competing trials, and quality medical records[, Phesi recommended conducting the trial in a single European country.

In just a few days, Phesi’s client received a clear and feasible trial design appraisal as well as operational guidance based on known issues from previous similar trials.

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