Discrepancies in endpoints between clinical trial protocols and clinical trial registration in randomized trials in oncology.

ABSTRACT:

Background

Clinical trials are an essential part of evidence-based medicine. Hence, to ensure transparency and accountability in these clinical trials, policies for registration have been framed with emphasis on mandatory submission of trial elements, specifically outcome measures. As these efforts evolve further, we sought to evaluate the current status of endpoint reporting in clinical trial registries.

Methods

We reviewed 71 oncology related randomized controlled trials published in three high impact journals. We compared primary (PEP) and non-primary endpoints (NPEP) between the clinical trial protocols of these trials and their corresponding registration in one of the 14 primary global clinical trial registries. A discrepancy was defined as the non-reporting or absence

SUBMITTER: Serpas VJ 

PROVIDER: S-EPMC6292048 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature