abandoned—a costly outcome that can harm the credibility of individual investigators and their institutions. The public and private organizations that fund trials look to a researcher’s and an institution’s prior history when making grant awards, and they take notice when investigators fail to meet their anticipated enrollment goals. From the investigator’s perspective, then, patient recruitment is a significant responsibility and not doing it effectively may lead to frustration, institutional concern, and even embarrassment.
Three major clinical trials in which Robert Michler, Surgeon-in-Chief, Professor and Chairman, and Director, Center for Heart and Vascular Care at the Montefiore Medical Center/Albert Einstein College of Medicine, actively participated all involved patients with serious heart disease for which surgery was a treatment alternative: Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial, Surgical Treatment for Ischemic Heart Failure (STICH) trial, and NHLBI–funded Cardiothoracic Surgical Trials Network (CTSN).
REMATCH evaluated whether a left ventricular assist device (LVAD)2 would reduce mortality compared to optimal medical management.3 Trial participants, who were primarily Medicare patients, needed but were ineligible for heart transplants. REMATCH investigators hoped to show that an LVAD could reduce 2-year mortality by one-third to one-half, compared to optimal medical management. The investigators planned to enroll 140 patients over eight calendar quarters. After eight quarters, no more than 80 patients had been enrolled. Michler noted that enrolling centers could not meet the expense of this complex trial and the federal government would not provide additional funding to complete the study. Additional funding from the trial’s industry sponsor helped the trial investigators complete the enrollment of 128 patients over 13 calendar quarters—suggesting the high cost and length of time it can take to achieve enrollment goals.
STICH, the largest surgical trial ever conducted, involving 2,135 patients enrolled in 127 sites across 26 countries, compared coronary bypass surgery with and without ventricular reconstruction of the left ventricle to optimal medical therapy in patients with significant heart
2 An LVAD is a surgically implanted pump that helps pump blood from the heart’s lower left chamber (the left ventricle) to the rest of the body.
3 Optimal medical management included adherence to guidelines developed by a medical committee with the goals of optimizing organ performance and minimizing symptoms of congestive heart failure. The medical committee provided specific guidance on the appropriate drug therapies for this severely ill patient population. Patients also received monthly follow-up when they were out of the hospital (Rose et al., 2001).