ASCO and the Society for Immunotherapy of Cancer (SITC) have released a joint statement with 12 clinical trial reporting recommendations that address the unique efficacy, toxicity, and combination/sequencing aspects of immuno-oncology (IO) treatments. These recommendations, jointly published in the Journal of Clinical Oncology and the Journal for ImmunoTherapy of Cancer, will lead to better IO trial reporting and assessment.
The unique efficacy and toxicity effects of IO therapies compared to traditional cancer therapies call for additional considerations for reporting the design, conduct, analysis, and results of IO clinical trials. As the number of IO clinical trials in cancer has rapidly increased, recommendations for reporting this research in biomedical journals will facilitate understanding and comparison across IO trials.
ASCO and SITC convened a working group of experts in 2016 to address the need for IO-specific clinical trial reporting guidance. The working group included representation from all specialties that contribute to IO trials, including practicing medical oncologists, immunologists, clinical researchers, biostatisticians, members of industry, and government representatives to develop reporting recommendations.
The work of the group of experts resulted in the Trial Reporting in Immuno-Oncology (TRIO) recommendations—12 recommendations developed through expert consensus. These recommendations aim to improve the completeness and consistency of reporting of IO trial efficacy and toxicity endpoints, as well as combination and sequencing studies to better facilitate interpretation and comparison of IO trial data in the medical literature.
The recommendations are assembled into three reporting categories to mirror methods currently used to report efficacy, toxicity, and combining or sequencing treatments across IO clinical trials.
ASCO is dedicated to supporting and improving clinical trials in ways that take full advantage of today’s scientific and technologic opportunities to realize major new advances in cancer prevention, detection, and treatment.
Read the full TRIO statement in the Journal of Clinical Oncology at http://ascopubs.org/doi/full/10.1200/JCO.18.00145. ■
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