We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Adverse Event Reporting Quality in Cancer Clinical Trials Evaluating Immune Checkpoint Inhibitor Therapy: A Systematic Review.
- Authors
Yuhong Wang; Chen Chen; Wei Du; Yixin Zhou; Lina He; Shaodong Hong; Li Zhang
- Abstract
Background: Immunotherapy has become one of the most important breakthroughs in cancer treatment. Consequently, there have been more immuno-oncology (IO) clinical trials for various cancers in recent decades. However, the quality of such trials in reporting adverse events (AE), especially immune-related AE (irAE), has not been comprehensively evaluated. Methods: We evaluated the harm reporting quality of IO trials. The PubMed, Embase, Cochrane Library, and Web of Science databases were searched to identify all head-tohead phase II and III clinical trials assessing cancer immunotherapy published between January 1, 2010, and December 31, 2021. Publications were assessed using a 16-point harm reporting quality score (HRQS) derived from the 2004 Consolidated Standards of Reporting Trials (CONSORT) extension. The characteristics associated with improved reporting quality were identified with linear regression. Results: A total of 123 publications were included. The mean HRQS was 11.1 (range, 5-14). The most common poorly reported items were harms addressed in the title (2%), AE collection methodology (3%), the statistical approach for analyzing harms (11%), and the irAE onset patterns and management (adequately reported in 14% and 33% of publications, respectively). The harm information was well described in the publications' Results and Discussion sections (89-99%). The multivariable regression model revealed that higher impact factor (IF) (30<IF<60 vs. IF<30, P=0.021) and phase III clinical trial (phase III vs. phase II, P=0.023) were independent predictors of higher quality score. Conclusion: Our findings show that AE reporting in IO randomized trials is suboptimal. Efforts should be made to improve harm reporting and to standardize reporting practices. Improvements in AE reporting would permit more balanced assessment of interventions and would enhance evidence-based IO practice.
- Subjects
IMMUNE checkpoint inhibitors; CLINICAL trials; IPILIMUMAB; WEB databases; SCIENCE databases; CRIME &; the press
- Publication
Frontiers in Immunology, 2022, Vol 13, p1
- ISSN
1664-3224
- Publication type
Article
- DOI
10.3389/fimmu.2022.874829