Analysis of patient-reported outcomes in the approval of novel oncology drugs in the United States, 2017-2022.

ABSTRACT:

Background

With the growing notion of patient-focused drug development, the quality of life and other patient-reported outcomes (PROs) of cancer patients are gaining considerable attention. Several drug regulatory agencies, including the U.S. Food and Drug Administration (FDA), are calling attention to PROs. This review aims to comprehensively characterise the application of PROs and regulatory considerations for PROs in the FDA-approved novel oncology drugs.

Methods

The FDA review documents and labels for novel oncology drugs approved from July 2017 to July 2022 were retrieved. We collected and analysed drug approval information, types of endpoints for PROs, PRO measures, designs of trials including PROs, and regulatory comments on PRO-related contents.

Findings

Resu

SUBMITTER: Ge C 

PROVIDER: S-EPMC10113764 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature