Clinical trial publications: A sufficient basis for healthcare decisions?

Published:January 13, 2020DOI:
      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.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Shepshelovich D.
        • Yahav D.
        • Tibau A.
        • Amir E.
        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])
        • Eichler H.G.
        • Sweeney F.
        The evolution of clinical trials: can we address the challenges of the future?.
        Clin Trials. 2018 Feb; 15: 27-32
      1. EMA website “ICH E8 General considerations for clinical studies.”.

      2. EMA website “Scientific advice and protocol assistance”.

      3. EMA website “Clinical data publication”.

        • Bothwell L.E.
        • Greene J.A.
        • Podolsky S.H.
        • Jones D.S.
        Assessing the gold standard–lessons from the history of RCTs.
        N Engl J Med. 2016 Jun 2; 374: 2175-2181
      4. EMA website “ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials.”.

      Linked Article