American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes.

See accompanying editorial on page 1186 Lee M. Ellis, University of Texas MD Anderson Cancer Center, Houston, TX; David S. Bernstein and Richard L. Schilsky, American Society of Clinical Oncology, Alexandria, VA; Emile E. Voest, University Medical Center Utrecht, Utrecht, the Netherlands; Jordan D. Berlin, Vanderbilt-Ingram Cancer Center, Nashville, TN; Daniel Sargent, Mayo Clinic, Rochester, MN; Patricia Cortazar, US Food and Drug Administration, Silver Spring, MD; Elizabeth Garrett-Mayer, Medical University of South Carolina, Charleston, SC; Roy S. Herbst and Rogerio C. Lilenbaum, Yale Cancer Center, New Haven, CT; Camelia Sima and Mithat Gonen, Memorial Sloan-Kettering Cancer Center, New York, NY; Alan P. Venook, Helen Diller Family Comprehensive Cancer Center at University of California San Francisco, San Francisco, CA; Neal J. Meropol, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH; Lowell E. Schnipper, Beth Israel Deaconess Medical Center, Boston, MA.