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Research Letter
September 2016

An Appraisal of Clinically Meaningful Outcomes Guidelines for Oncology Clinical Trials

Author Affiliations
  • 1Department of Medical Oncology, Kasturba Medical College, Manglaore, India
  • 2Division of Hematology and Oncology, Columbia University Medical Center, New York, New York
  • 3Myeloma Service, Division of Hematologic Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
JAMA Oncol. 2016;2(9):1238-1240. doi:10.1001/jamaoncol.2016.0931

In the past decade, several new therapies have been approved for patients with cancer, with incremental improvements in outcomes.1 Although any advance in the treatment of cancer is welcome, for many of these therapies, the effect on survival has been marginal; consequently, the high costs associated with their administration has caused concern among patients and physicians.1,2 Recognizing the need to raise standards for cancer clinical trials and define clinically meaningful outcomes, the American Society of Clinical Oncology (ASCO) Cancer Research Committee convened 4 disease-specific working groups to provide meaningful goals for future clinical trials.3 The goals chosen were deliberately modest, in recognition that more ambitious goals would be seen as unrealistic and unachievable. More important, these goals were not intended for regulatory approvals or insurance coverage; rather, they were proposed so that patients and physicians could demand better outcomes from cancer clinical trials.

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