Table 1.

Trial reporting in immuno-oncology (TRIO) standards

Reporting Standards
Efficacy reporting standards
1. Report the criteria used to evaluate response to therapy and the rationale for the chosen criteria.
2. Include spider plots or swimmer plots in efficacy descriptions to better report kinetics of response (Figs 1 and 2).
3. Report how disease control rate is defined and how its components are assessed.
4. Report criteria that allow patients to continue treatment beyond disease progression.
5. Report the number (proportion) of patients who are treated beyond progression, treatment beyond progression duration, emergence of new toxicity, and efficacy after initial progression.
6. Report progression-free survival and overall survival using Kaplan-Meier analyses.
Toxicity reporting standards
7. Differentiate between the clinical diagnoses of IO toxicity and the specific symptoms that led to the diagnoses.
8. If the prespecified clinical diagnoses used in data collection belong to categories such as “immune-related adverse events” or “adverse events of special interest,” report how these terms are defined and why these categories were selected for trial reporting
9. Report all toxicity by specific grade.
10. Report clinical interventions used to manage IO toxicity (Table 2).
11. Report time of onset and duration of IO toxicity (Table 2).
Combination or sequencing of immunotherapies reporting standard
12. Report the scientific hypothesis for the combination or sequence on the basis of preclinical and/or clinical data as well as the rationale for the selection of the particular dose(s) and sequence of agents.

Standards 1 to 5 and 7 to 11 are unique to immuno-oncology (IO) therapies