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Pervasive problems related to the recruitment and retention of participants in clinical research threaten our ability to produce timely data necessary to guide practice and policy. For example, the Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction trial took >7 years to recruit, averaging 1 patient per center every 6.25 months.1 The Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study With Tolvaptan (EVEREST) trial involved 436 sites to enroll 4133 patients; 77 sites enrolled no patients; and the median enrollment among active sites was only 6.2,3 Related to this, a major barrier to both Food and Drug Administration approval and acceptance among cardiologists of rivaroxaban in the setting of acute coronary syndrome seems to have been uncertainty related to high rates of loss to follow-up among enrolled subjects in the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects With Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction (ATLAS ACS–TIMI 51) trial.4,5 These problems are not universal. The Acute Study of Clinical Effectiveness of Nesiritidein Decompensated Heart Failure (ASCEND-HF) study, for example, successfully randomized 7141 patients in just >3 years (although it did involve ≈400 sites).6 The precise reasons for the variability in recruitment and retention are poorly understood and likely vary by center, by condition, and by study.7Slow recruitment and inadequate retention delay clinical knowledge, and differences in participant characteristics, withdrawal rates, and outcomes introduce uncertainty and limit generalizability. Despite uniform and extensive inclusion and exclusion criteria, low-enrolling sites in EVEREST enrolled sicker patients, had higher rates of protocol noncompletion for reasons other than adverse events, and had a greater incidence of primary adverse outcomes.3 Low enrollment also depletes resources, escalates costs, and fuels migration of research away from the United States, further limiting generalizability …

Incentivizing Recruitment and Retention to Address Enrollment Challenges in Clinical Research