title: Lessons learned from radiation oncology clinical trials.
abstract: A workshop entitled "Lessons Learned from Radiation Oncology Trials" was held on December 7-8, 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: (i) opportunities to learn from null-hypothesis trials through tissue and imaging studies; (ii) value of preclinical data supporting the design of combinatorial therapies; (iii) significance of validated biomarkers; (iv) necessity of quality assurance in radiotherapy delivery; (v) conduct of sufficiently powered studies to address the central hypotheses; and (vi) 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, to effectively merge the technologic innovations with the rapidly evolving biology for maximal patient benefit through the design of future clinical trials.
authors.affiliation: Authors' Affiliations: Department of Radiation Oncology, Princess Margaret Cancer Center, Toronto, Ontario, Canada; Department of Radiation Oncology, University of Florida Shands Cancer Center, Gainesville, Florida; Radiation Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda; Molecular Radiation Therapeutics Branch, Division of Cancer Treatment and Diagnosis, and Clinical Radiation Oncology Branch, National Cancer Institute, Rockville, Maryland; Department of Radiation Oncology, Stanford University, Palo Alto, California; Department of Radiation Oncology, University of Iowa Hospitals and Clinics, Iowa City, Iowa; and Department of Radiation Oncology, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York.
authors.forename: Fei-Fei
authors.initials: FF
authors.lastname: Liu
authors.forename: Paul
authors.initials: P
authors.lastname: Okunieff
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Bernhard
authors.forename: Helen B
authors.initials: HB
authors.lastname: Stone
authors.forename: Stephen
authors.initials: S
authors.lastname: Yoo
authors.forename: C Norman
authors.initials: CN
authors.lastname: Coleman
authors.forename: Bhadrasain
authors.initials: B
authors.lastname: Vikram
authors.forename: Martin
authors.initials: M
authors.lastname: Brown
authors.forename: John
authors.initials: J
authors.lastname: Buatti
authors.forename: Chandan
authors.initials: C
authors.lastname: Guha
mesh_terms: D014408:Biomarkers, Tumor; D002986:Clinical Trials as Topic / Q000379:methods*; D003131:Combined Modality Therapy; D006801:Humans; D009369:Neoplasms / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D017211:Treatment Failure
chemical_list: D014408:Biomarkers, Tumor
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