Apostolia M Tsimberidou1, Laura A Levit2, Richard L Schilsky2, Steven D Averbuch3, Daniel Chen4, John M Kirkwood5, Lisa M McShane6, Elad Sharon6, Kathryn F Mileham7, Michael A Postow8. 1. 1 University of Texas MD Anderson Cancer Center, Houston, TX. 2. 2 American Society of Clinical Oncology, Alexandria, VA. 3. 3 Bristol-Myers Squibb, Princeton, NJ. 4. 4 Genentech, South San Francisco, CA. 5. 5 University of Pittsburgh Cancer Institute, Pittsburgh, PA. 6. 6 National Cancer Institute, Bethesda, MD. 7. 7 Atrium Health, Charlotte, NC. 8. 8 Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.
Abstract
PURPOSE: To develop recommendations for clinical trial reporting that address the unique efficacy, toxicity, and combination and sequencing aspects of immuno-oncology (IO) treatments. METHODS: ASCO and the Society for Immunotherapy of Cancer (SITC) convened a working group that consisted of practicing medical oncologists, immunologists, clinical researchers, biostatisticians, and representatives from industry and government to develop Trial Reporting in Immuno-Oncology (TRIO) recommendations. These recommendations are based on expert consensus, given that existing data to support evidence-based recommendations are limited. CONCLUSION: The TRIO recommendations are intended to improve the reporting of IO clinical trials and thus provide more complete evidence on the relative benefits and risks of an IO therapeutic approach. Given the rapid expansion of the number of IO clinical trials and ongoing improvements to the evidence base supporting the use of IO treatments in clinical care, these recommendations will likely need regular revision as the IO field develops.
PURPOSE: To develop recommendations for clinical trial reporting that address the unique efficacy, toxicity, and combination and sequencing aspects of immuno-oncology (IO) treatments. METHODS: ASCO and the Society for Immunotherapy of Cancer (SITC) convened a working group that consisted of practicing medical oncologists, immunologists, clinical researchers, biostatisticians, and representatives from industry and government to develop Trial Reporting in Immuno-Oncology (TRIO) recommendations. These recommendations are based on expert consensus, given that existing data to support evidence-based recommendations are limited. CONCLUSION: The TRIO recommendations are intended to improve the reporting of IO clinical trials and thus provide more complete evidence on the relative benefits and risks of an IO therapeutic approach. Given the rapid expansion of the number of IO clinical trials and ongoing improvements to the evidence base supporting the use of IO treatments in clinical care, these recommendations will likely need regular revision as the IO field develops.
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