Clin Cancer Res. 2013 Sep 16. [Epub ahead of print]
Lessons Learned from Radiation Oncology Clinical Trials.
Source
Departments of Radiation Oncology, Medical Biophysics, Medical Oncology, Laboratory Medicine and Pathology and Biostatistics/Radiation Medicine Program, University of Toronto/Princess Margaret Hospital, University Health Network.
Abstract
A Workshop entitled "Lessons Learned from Radiation Oncology Trials" was held on December 7-8th, 2011 in Bethesda, MD, to present and discuss some of the recently conducted Radiation Oncology clinical trials with a focus on those that failed to refute the null hypothesis. The objectives of this Workshop were to summarize and examine the questions that these trials provoked, to assess the quality and limitations of the preclinical data that supported the hypotheses underlying these trials, and to consider possible solutions to these challenges for the design of future clinical trials. Several themes emerged from the discussions, including: a) opportunities to learn from null-hypothesis trials through tissue and imaging studies; b) value of preclinical data supporting the design of combinatorial therapies; c) significance of validated biomarkers; d) necessity of quality assurance in radiotherapy delivery; e) conduct of sufficiently-powered studies to address the central hypotheses; and f) importance of publishing results of the trials regardless of the outcome. The fact that well-designed hypothesis-driven clinical trials produce null or negative results is expected given the limitations of trial design, and complexities of cancer biology. It is important to understand the reasons underlying such null results however, in order to effectively merge the technological innovations with the rapidly evolving biology for maximal patient benefit, through the design of future clinical trials.
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