Inclusion, characteristics, and reporting of older adults in FDA registration studies of immunotherapy, 2018-2022.

ABSTRACT: Immune checkpoint inhibitors (ICI) have transformed the management of cancer, particularly for older adults, who constitute a majority of the global cancer patient population. This study aimed to assess the inclusion, characteristics, and reporting of older adults enrolled in Food and Drug Administration (FDA) registration clinical trials of ICI between 2018 and 2022. Clinical trials of ICI leading to an FDA approval in solid tumor oncology between 2018 and 2022 were included. Primary study reports and all available secondary publications were assessed. The availability and completeness of older subgroup data for protocol-defined clinical efficacy endpoints, health-related quality of life (HRQOL) and toxicity outcomes, and baseline characteristics were assessed according to predefined crit

SUBMITTER: Mac Eochagain C 

PROVIDER: S-EPMC11367347 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature