Protocol publication rate and comparison between article, registry and protocol in RCTs.

ABSTRACT:

Background

Increasing transparency in clinical research is crucial to avoid misleading conclusions. Registering clinical trials prior to participant enrolment is mandatory, and the publication of trial protocols could further enhance transparency. However, the impact of protocol publication on primary outcomes (PO) and sample sizes (SS) remains unclear. This study aimed to determine the rates of trial protocol publication and registration for a sample of randomized controlled trials (RCTs) and to compare the consistency of published and registered PO and SS.

Methods

A search was conducted in MEDLINE via PubMed^® for RCT reports indexed in May and June 2023 across various medical specialties, focusing on general and high-impact factor journals. Data were extracted r

SUBMITTER: Mathieu S 

PROVIDER: S-EPMC11786558 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature