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

Author:

Coskinas Xanthi1,Simes R John1,Martin Andrew J1

Affiliation:

1. NHMRC Clinical Trials Centre the University of Sydney Sydney NSW

Publisher

Wiley

Subject

General Medicine

Reference17 articles.

1. National Health and Medical Research Council; Australian Research Council; Universities Australia. National statement on ethical conduct in human research 2007 (updated 2018). July 2018.https://www.nhmrc.gov.au/about‐us/publications/national‐statement‐ethical‐conduct‐human‐research‐2007‐updated‐2018#block‐views‐block‐file‐attachments‐content‐block‐1(viewed Dec 2021).

2. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

3. International Committee of Medical Journal Editors. Recommendations for the conduct reporting editing and publication of scholarly work in medical journals. Updated May 2022.https://www.icmje.org/icmje‐recommendations.pdf(viewed July 2022).

4. Changes to aspects of ongoing randomised controlled trials with fixed designs

5. Reacting to prognostic covariate imbalance in randomised controlled trials

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