Clinical studies remain the single most important information source of the scientific
basis on which healthcare decisions are taken. This applies to population-level decisions
taken by drug regulators or healthcare payers as well as individual-level decisions
taken by patients and their physicians. With respect to drug treatments, adequately
designed, executed, and reported randomised controlled trials (RCTs) have often been
described as the “gold standard” for decision making. High expectations and ethical
responsibilities are riding on publications of RCTs in peer reviewed journals.
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References
- Assessment of frequency and reporting of design changes among clinical drug trials published in influential medical journals.Eur J Intern Med. 2019 Aug 19; (pii: S0953-6205(19)30294-8[Epub ahead of print])https://doi.org/10.1016/j.ejim.2019.08.009
- The evolution of clinical trials: can we address the challenges of the future?.Clin Trials. 2018 Feb; 15: 27-32https://doi.org/10.1177/1740774518755058
EMA website “ICH E8 General considerations for clinical studies.”.
EMA website “Scientific advice and protocol assistance”.
EMA website “Clinical data publication”.
- Assessing the gold standard–lessons from the history of RCTs.N Engl J Med. 2016 Jun 2; 374: 2175-2181https://doi.org/10.1056/NEJMms1604593
EMA website “ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials.”.
Article info
Publication history
Published online: January 13, 2020
Accepted:
November 26,
2019
Received:
November 25,
2019
Identification
Copyright
© 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
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- Assessment of frequency and reporting of design changes among clinical drug trials published in influential medical journalsEuropean Journal of Internal MedicineVol. 71
