Adverse Event Reporting Quality in Cancer Clinical Trials Evaluating Immune Checkpoint Inhibitor Therapy: A Systematic Review.

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-to-head 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 Reportin

SUBMITTER: Wang Y 

PROVIDER: S-EPMC9301013 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature