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Original Investigation | Health Care Reform

Characteristics of Oncology Clinical Trials:  Insights From a Systematic Analysis of ClinicalTrials.gov

Bradford R. Hirsch, MD, MBA; Robert M. Califf, MD; Steven K. Cheng, PhD; Asba Tasneem, PhD; John Horton, MS; Karen Chiswell, PhD; Kevin A. Schulman, MD, MBA; David M. Dilts, PhD; Amy P. Abernethy, MD
JAMA Intern Med. 2013;173(11):972-979. doi:10.1001/jamainternmed.2013.627.
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Importance 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%; P < .001), open label (87.8% vs 47.3%; P < .001), and nonrandomized (63.9% vs 22.7%; P < .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.

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Figure 1. Methods used to derive oncology data set.

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Figure 2. Comparison of incidence (estimated new cases) (A) and death (B) in 2010 with number of trials on ClinicalTrials.gov for common cancer types. AML indicates acute myelogenous leukemia; CNS, central nervous system.

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Figure 3. Comparison of 5-year survival by cancer subtype across stages with proportions of single-arm, randomized, and phase 3 treatment trials (survival data from Ozols et al27).

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