A Retrospective Time and Cost Comparison Analysis of Patient Enrollment Options for a Long-term CV Outcomes Trial



The sponsor’s original goal for this six-year trial was to enroll 18,000 patients. However, like most long-term studies, it turned out to be a very difficult and costly trial to enroll. After three and a half years, patient enrollment rates were far below commitments, and 750 U.S. sites had randomized only 2,200 subjects.

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