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Additional clinical benefit independent of study result or trial arm allocation to participants in multi-center randomized controlled trials

  • Shaul Atar
    Correspondence
    Galilee Medical Center, 1 Ben Tzvi Blvd., Nahariya 2210001, Israel.
    Affiliations
    Department of Cardiology, Galilee Medical Center, Nahariya, affiliated with the Faculty of Medicine in the Galilee, Bar Ilan University, Safed, Israel
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Published:September 03, 2016DOI:https://doi.org/10.1016/j.ejim.2016.08.031
      Randomized controlled trials (RCT) are the definitive method for determining primary treatment efficacy and a crucial step in the development of novel therapies. Patients may participate in such trials for altruistic reasons [
      • Jenkins V.
      • Farewell V.
      • Farewell D.
      • Darmanin J.
      • Wagstaff J.
      • Langridge C.
      • et al.
      Drivers and barriers to patient participation in RCTs.
      ,
      • Welton A.J.
      • Vickers M.R.
      • Cooper J.A.
      • Meade T.W.
      • Marteau T.M.
      Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study.
      ], but probably also in hope for additional benefit [
      • Welton A.J.
      • Vickers M.R.
      • Cooper J.A.
      • Meade T.W.
      • Marteau T.M.
      Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study.
      ]. An enhanced sense of care beyond the classic physician — patient relationship and more rigorous adherence to ‘best practice’ standards and international guidelines may be a major incentive for these patients. Yet, when being consulted as to whether to participate in such a trial or not, many primary care physicians recommend to refrain from participating. It is most likely that patients and clinicians alike, in the process of making the decision, do not take into consideration the possible benefit from participation alone, independent of the actual study outcome or the trial arm allocation.

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