Application of Patient-Reported Outcome Measurements in Clinical Trials in China.

ABSTRACT:

Importance

Regulatory authorities, industry peers, and international health policies have emphasized the value of assessing patient-reported outcomes (PROs) in clinical studies. Despite the increase in the number of clinical studies in the last decade in China, little is known about the extent of the use of PROs.

Objective

To evaluate the application and characteristics of PRO instruments as primary and secondary outcomes in randomized clinical trials in China.

Design, setting, and participants

A cross-sectional study of interventional clinical trials conducted in China from January 1, 2010, to December 31, 2020, was performed. Data obtained from the Chinese Clinical Trial Registry and ClinicalTrials.gov databases were evaluated.

Main outcomes and measures

Tria

SUBMITTER: Zhou H 

PROVIDER: S-EPMC9096600 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature