Patient-Reported Outcomes in Clinical Trials Leading to Cancer Immunotherapy Drug Approvals From 2011 to 2018: A Systematic Review.

ABSTRACT:

Background

Patient-reported outcomes (PROs) promote patient centeredness in clinical trials; however, in the field of rapidly emerging and clinically impressive immunotherapy, data on PROs are limited.

Methods

We systematically identified all immunotherapy approvals from 2011 through 2018 and assessed the analytic tools and reporting quality of associated PRO reports. For randomized clinical trials (RCTs), we developed a novel 24-point scoring scale: the PRO Endpoints Analysis Score based on 24 criteria derived from the recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium.

Results

We assessed 44 trial publications supporting 42 immunotherapy approvals. PROs were published for 21 of

SUBMITTER: Safa H 

PROVIDER: S-EPMC8096374 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature