Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials.

ABSTRACT:

Background

This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV clinical trials.

Methods

Two reviewers independently assessed CTRs of the International Committee of Medical Journal Editors (ICJME) and of World Health Organization (WHO) platforms. Each CTR was checked by two reviewers on availability of fields on brand name, manufacturer's name, approval status, approving authority, compliance with Good Manufacturing Practices, and quality testing. In case of discrepancy, consensus was sought between the two reviewers.

Results

Of 19 identified CTRs, 8 and 6 belonged to WHO and ICMJE, respectively, while 5 were equall

SUBMITTER: Doua YJ 

PROVIDER: S-EPMC6460528 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature