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Motzer RJ, Escudier B, Oudard S, et al: Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase III trial. Lancet 372:449-456, 2008 35. Hudes G, Carducci M, Tomczak P, et al: Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 356:2271-2281, 2007 DOI: 10.1200/JCO.2010.31.5044; published online ahead of print at www.jco.org on October 25, 2010 ■■■ Clinical Trials Data Collection: When Less Is More Daniel J. Sargent, Mayo Clinic, Rochester, MN Stephen L. George, Duke University, Durham, NC See accompanying article on page 5046 The oncology clinical trials enterprise is clearly under duress. Despite the many documented successes in introducing new therapies to patients over the last 50 years, reform in virtually every area of the system is needed. 1 Harold Varmus, MD, in his introductory address as director of the US National Cancer Institute (NCI), indicated one of his first priorities is to fix the “dysfunctional” clinical trials system. 2 Many aspects of the process have appropriately come under close examination, including the substantial time and effort required to Editorials www.jco.org © 2010 by American Society of Clinical Oncology 5019 Downloaded from jco.ascopubs.org on February 19, 2013. For personal use only. No other uses without permission. Copyright © 2010 American Society of Clinical Oncology. All rights reserved.