Michael A. Postow, MD
The standards for reporting findings from immunotherapy studies should reflect the unique efficacy and toxicity characteristics of this rapidily emerging modality, with detailed and transparent explanations of definitions, according to a panel of experts.
The recommendations were developed starting in 2016 by a working group of members of ASCO and SITC that included medical oncologists, clinical researchers, biostatisticians, and immunologists, as well as government and industry members. The 12 recommendations are grouped under efficacy data, toxicity information, or details about combination therapies. The recommendations are listed here verbatim as bullet points.
Standards for Efficacy Reporting
• Report the criteria used to evaluate response to therapy and the rationale for the selected criteria
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