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Unsatisfied Reporting Quality of Clinical Trials Evaluating Immune Checkpoint Inhibitor Therapy in Cancer
Chen Chen1,2, Yixin Zhou2,3, Xuanye Zhang2,4
1Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Background:
More and more immune-oncology trials have been conducted for treating various cancers, yet it is unclear what the reporting quality of immune-oncology trials is,and characteristics associated with higher reporting quality.
Objective:
This study aims to evaluate the reporting quality of immune-oncology trials.
Methods:
The PubMed and Cochrane library were searched to identify all English publications of clinical trials assessing immunotherapy for cancer. Reporting quality of immune-oncology trials was evaluated by a quality score with 11 points derived from the Trial Reporting in Immuno-Oncology (TRIO) statement, which contained two parts: an efficacy score of 6 points and toxicity score of 5 point. Linear regression was used to identify characteristics associated with higher scores.
Results:
Of the 10,169 studies screened, 298 immune-oncology trial reports were enrolled. The mean quality score, efficacy score, and toxicity score were 6.46, 3.61, and 2.85, respectively. The most common well-reported items were response evaluation criteria (96.0%) and toxicity grade (98.7%), followed by Kaplan-Meier survival analyses (80.5%). Treatment details beyond progression (12.8%) and toxicity onset time and duration (7.7%) were poorly reported. Multivariate regression revealed that higher impact factor (IF) (IF >20 vs. IF <5, p < 0.001), specific tumor type (p = 0.018 for lung, p = 0.021 for urinary system, vs. pan cancer), and a certain kind of immune checkpoint blocking agent (p < 0.001 for anti-PD-1 or multiagents, vs. anti-CTLA-4) were independent predictors of higher-quality score. Similar independent predictive characteristics were revealed for high-efficacy score. Only IF >20 had a significant high-toxicity score (p < 0.001).
Conclusion:
Immune-oncology trial reports presented an unsatisfied quality score, especially in the reporting of treatment details beyond progression and toxicity onset time and duration. High IF journals have better reporting quality. Future improvement of trial reporting was warranted to the benefit-risk assessment of immunotherapy.
Insights
Immune-oncology trial reporting quality is unsatisfactory, particularly for treatment details beyond progression and toxicity. Higher impact factor journals show better reporting, emphasizing the need for improved trial reporting to accurately assess immunotherapy benefits and risks.
Area of Science:
- Oncology
- Immunology
- Clinical Trials
Background:
- Growing number of immune-oncology trials for various cancers.
- Unclear reporting quality and associated characteristics of these trials.
Purpose of the Study:
- Evaluate the reporting quality of immune-oncology trials.
- Identify characteristics linked to superior reporting quality.
Main Methods:
- Searched PubMed and Cochrane Library for immunotherapy cancer trials.
- Assessed reporting quality using the 11-point Trial Reporting in Immuno-Oncology (TRIO) statement (efficacy and toxicity).
- Employed linear regression to find predictors of higher scores.
Main Results:
- 298 trial reports analyzed; mean quality score was 6.46 (efficacy 3.61, toxicity 2.85).
- Well-reported items included response criteria and toxicity grades; poorly reported were treatment details beyond progression and toxicity onset/duration.
- Higher impact factor (IF), specific tumor types (lung, urinary), and certain agents (anti-PD-1, multiagents) predicted higher quality scores.
Conclusions:
- Immune-oncology trial reports exhibit suboptimal quality, especially regarding treatment beyond progression and toxicity details.
- Journals with higher impact factors demonstrate superior reporting quality.
- Enhancing trial reporting is crucial for accurate benefit-risk assessments of immunotherapies.
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