Purpose The authors sought to assess 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-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 set-up, 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. While 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.

Purpose: Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time.Experimental Design: National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals.Results: Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time.Conclusions: A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. Clin Cancer Res; 16(22); 5557-63. ©2010 AACR.In the United States, it is estimated that 1.4 million individuals will be diagnosed with cancer, and over half a million will die each year. Advances in therapeutic treatments have improved the 5-year survival rates over the past four decades (1), yet cancer continues to be the second leading cause of death in Americans, resulting in more deaths than the next five causes combined (2). New and innovative therapeutic approaches to improve the standard of care for cancer patients must be developed and then confirmed through a series of clinical trial phases to ensure both efficacy and safety. Phase I to III trials require sufficient patient enrollment so that not only can the efficacy of the therapeutic agent(s) under investigation be tested with a proper degree of statistical certainty, but also to maximize the generalizability of the findings to the intended patient population. Unfortunately, with only 2% to 7% of the adult cancer population participating in clinical trials, obtaining sufficient accrual is a known barrier to successful completion of clinical trials (3, 4). Furthermore, it has been shown that the lack of appropriate trials represents a significant barrier to accruing oncology patients (5). Hence...

Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement. Objective: To perform a comprehensive analysis of the national oncology clinical research portfolio. Design: All interventional clinical studies registered on ClinicalTrials.gov between October 2007 and September 2010 were identified using Medical Subject Heading terms and submitted conditions. They were reviewed to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties. Results: Of 40 970 interventional studies registered between October 2007 and September 2010, a total of 8942 (21.8%) focused on oncology. Compared with other specialties, oncology trials were more likely to be single arm (62.3% vs 23.8%; PϽ.001), open label (87.8% vs 47.3%; P Ͻ .001), and nonrandomized (63.9% vs 22.7%; P Ͻ .001). There was moderate but significant correlation between number of trials conducted by cancer type and associated incidence and mortality (Spearman rank correlation coefficient, 0.56 [P=.04] and 0.77 [P=.001], respectively). More than one-third of all oncology trials were conducted solely outside North America.Conclusions and Relevance: There are significant variations between clinical trials in oncology and other diseases, as well as among trials within oncology. The differences must be better understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.