TY - JOUR
T1 - Trial reporting in immuno-oncology (TRIO)
T2 - An American society of clinical oncology-society for immunotherapy of cancer statement
AU - Tsimberidou, Apostolia M.
AU - Levit, Laura A.
AU - Schilsky, Richard L.
AU - Averbuch, Steven D.
AU - Chen, Daniel
AU - Kirkwood, John M.
AU - McShane, Lisa M.
AU - Sharon, Elad
AU - Mileham, Kathryn F.
AU - Postow, Michael A.
N1 - Funding Information:
ASCO and SITC thank the following individuals for participating in the immunotherapy working group: Jeff Allen (Friends of Cancer Research), Donald Berry (MD Anderson Cancer Center), Lajos Pusztai (Yale Cancer Center), Marc Theoret (US Food and Drug Administration), Lauren Wood (National Cancer Institute), Jeffrey S. Weber (Perlmutter Cancer Center), and Cassian Yee (MD Anderson Cancer Center). We also thank the following ASCO staff for their contributions to the project: Caroline Schenkel, Nicole Jenkins, and Suanna S. Bruinooge.
Funding Information:
Apostolia M. Tsimberidou Consulting or Advisory Role: Roche Research Funding: EMD Serono (Inst), Baxter (Inst), Foundation Medicine (Inst), Onyx Pharmaceuticals (Inst), Bayer HealthCare Pharmaceuticals (Inst), Boston Biomedical (Inst), Placon Therapeutics (Inst), Immatics Biotechnologies (Inst), Karus Therapeutics (Inst), Tvardi Therapeutics (Inst), OBI Pharma (Inst)
Publisher Copyright:
Copyright © 2019 American Society of Clinical Oncology. All rights reserved.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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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U2 - 10.1200/JCO.18.00145
DO - 10.1200/JCO.18.00145
M3 - Article
C2 - 30339040
AN - SCOPUS:85059245195
SN - 0732-183X
VL - 37
SP - 72
EP - 80
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 1
ER -