Purpose: The authors assessed the prevalence and associated economic impact of low-enrolling clinical studies at a single academic medical center.
Method: The authors examined all clinical studies receiving institutional review board (IRB) review between FY2006 and FY2009 at Oregon Health & Science University (OHSU) for recruitment performance and analyzed them by type of IRB review (full-board, exempt, expedited), funding mechanism, and academic unit. A low-enrolling study included those with zero or one participant at the time of study termination. The authors calculated the costs associated with IRB review, financial setup, contract negotiation, and department study start-up activities and the total economic impact on OHSU of low-enrolling studies for FY2009.
Results: A total of 837 clinical studies were terminated during the study period, 260 (31.1%) of which were low-enrolling. A greater proportion of low-enrolling studies were government funded than industry funded (P = .006). The authors found significant differences among the various academic units with respect to percentages of low-enrolling studies (from 10% to 67%). The uncompensated economic impact of low-enrolling studies was conservatively estimated to be nearly $1 million for FY2009.
Conclusions: A substantial proportion of clinical studies incurred high institutional and departmental expense but resulted in little scientific benefit. Although a certain percentage of low-enrolling studies can be expected in any research organization, the overall number of such studies must be managed to reduce the aggregate costs of conducting research and to maximize research opportunities. Effective, proactive interventions are needed to address the prevalence and impact of low enrollment.
Ms. Kitterman is director, Investigator Support and Integration Services, Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, Oregon.
Dr. Cheng is senior research associate, Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon.
Dr. Dilts is director of clinical research, Knight Cancer Institute, and professor of management, Division of Management, Oregon Health & Science University, Portland, Oregon.
Dr. Orwoll is director, Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, Oregon.
Correspondence should be addressed to Ms. Kitterman, 3181 S.W. Sam Jackson Park Rd., Portland, OR 97239; telephone: (503) 494-6263; fax: (503) 494-0165; e-mail: firstname.lastname@example.org.
Editor's Note: A commentary on this article appears on page 1334.
First published online September 26, 2011