Changes to design and analysis elements of research plans during randomised controlled trials in Australia.

ABSTRACT:

Objectives

To investigate the frequency and legitimacy of substantive changes to the research plans of published randomised controlled trials (RCTs) undertaken in Australia.

Design

Comparison of methodology and analysis plans for RCTs specified in protocol documents (full protocols, published protocol articles, statistical analysis plans, Australian New Zealand Clinical Trials Registry [ANZCTR] registration entries) and described in publications of primary results.

Setting, participants

181 RCTs registered with the ANZCTR, 1 September 2007 - 31 December 2013, for which primary results had been published.

Main outcome measure

Changes made to research plan, both overall and by specific item (primary outcome, analysis set, eligibility criteria, sample size, primar

SUBMITTER: Coskinas X 

PROVIDER: S-EPMC9826265 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature