Traditional informed consent procedures are believed to make pragmatic trials impracticable if they lead to low enrollment and a study sample that is not ...
Practical steps to identifying the research risk of pragmatic trials
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Mar 29, 2022 · 22. Dal-Ré R, Avendaño-Solà C, Bloechl-Daum B, et al. Low risk pragmatic trials do not always require participants' informed ...
Low risk pragmatic trials do not always require participants' informed consent ... Authors: Rafael Dal-Ré; Cristina Avendaño-Solà; Brigitte Bloechl-Daum ...
Dec 21, 2018 · Across scenarios, weighted data showed that 75.4% of the participants would recommend approval of the postrandomization consent pragmatic trial, ...
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The results demonstrate that most participants felt that it was important for eligible individuals to be informed about these types of trials. However, most ...
May 16, 2017 · We conclude that that there are salient differences between pragmatic trials, especially between premarket EPTs and pragmatic trials with ...
Apr 8, 2019 · The demand for written informed consent is an obstacle to pragmatic trials. By creating, once again, artificial selection of patients, results ...
Sep 18, 2017 · The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve ...
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Request PDF | Participants' written informed consent in low-risk pragmatic clinical trials with medicines | Introduction: An important gap within modern ...
Aug 5, 2024 · ... participants; it prioritizes ... They argued that specific written informed consent should not be mandatory for all randomized trials ...