Quality of Drug Clinical Trials in China: A Mixed Methods Research.

ABSTRACT:

Aim

The quality of drug clinical trials is crucial for authorizing new drugs and fostering innovations in clinical practice. This study aimed to report the status, trends, and factors of the quality of drug clinical trials in China.

Methods

This mixed methods study assessed trial quality using quantitative data from public sources and qualitative data from focus groups and interviews with key stakeholders.

Results

The No Action Indicated findings issued by the Food and Drug Administration increased from 43% from 2009-2015 to 88% from 2016-2022, whereas the Official Action Indicated findings decreased from 9% to 0% (p = 0.001). The Center for Food and Drug Inspection revealed that 12% of new drug applications in 2015-2017 were suspected of data fabrication, compared to

SUBMITTER: Chen X 

PROVIDER: S-EPMC12750488 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature