Journal article
Lessons Learned from Radiation Oncology Clinical Trials
Clinical cancer research, Vol.19(22), pp.6089-6100
11/15/2013
DOI: 10.1158/1078-0432.CCR-13-1116
PMCID: PMC3965328
PMID: 24043463
Abstract
A Workshop entitled “Lessons Learned from Radiation Oncology Trials” was held on December 7–8
th
, 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 pre-clinical 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 the: a) opportunities to learn from null-hypothesis trials through tissue and imaging studies; b) value of pre-clinical 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 hypothesis; 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.
Details
- Title: Subtitle
- Lessons Learned from Radiation Oncology Clinical Trials
- Creators
- Fei-Fei Liu - Department of Radiation Oncology, Princess Margaret Cancer Center, Toronto, CanadaPaul Okunieff - Department of Radiation Oncology, University of Florida, GainesvilleEric J Bernhard - Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, BethesdaHelen B Stone - Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, BethesdaStephen Yoo - Molecular Radiation Therapeutics Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, RockvilleC. Norman Coleman - Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, BethesdaBhadrasain Vikram - Clinical Radiation Oncology Branch, National Cancer Institute, RockvilleMartin Brown - Department of Radiation Oncology, Stanford University, StanfordJohn Buatti - Department of Radiation Oncology, University of Iowa Hospitals and Clinics, Iowa CityChandan Guha - Department of Radiation Oncology, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx
- Resource Type
- Journal article
- Publication Details
- Clinical cancer research, Vol.19(22), pp.6089-6100
- DOI
- 10.1158/1078-0432.CCR-13-1116
- PMID
- 24043463
- PMCID
- PMC3965328
- ISSN
- 1078-0432
- eISSN
- 1557-3265
- Language
- English
- Date published
- 11/15/2013
- Academic Unit
- Radiation Oncology; Neurosurgery; Otolaryngology
- Record Identifier
- 9984040457602771
Metrics
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