TY - JOUR
T1 - The prevalence and economic impact of low-enrolling clinical studies at an academic medical center
AU - Kitterman, Darlene R.
AU - Cheng, Steven K.
AU - Dilts, David
AU - Orwoll, Eric S.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2011/11
Y1 - 2011/11
N2 - 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.
AB - 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.
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U2 - 10.1097/ACM.0b013e3182306440
DO - 10.1097/ACM.0b013e3182306440
M3 - Article
C2 - 21952064
AN - SCOPUS:80255123795
SN - 1040-2446
VL - 86
SP - 1360
EP - 1366
JO - Academic Medicine
JF - Academic Medicine
IS - 11
ER -