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Качественная клиническая практика, 2020 Pragmatic clinical trials (PCTs) allow combining the advantages of observational trials in real-world evidence with the scientific rigor of randomized clinical trials (RCTs), and thereby provide more effective answers to questions of real-world evidence ...
O. R. Shevchenko, A. S. Kolbin
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Implementing pragmatic clinical trials in hepatology. [PDF]
Hepatology, 2023 Patients with chronic liver disease would benefit from pragmatic trial designs. A pragmatic trial seeks to inform clinical decision-making by providing evidence for the adoption of an intervention into real-world clinical practice. A trial’s pragmatism is based on the efficiency by which it identifies, recruits, and follows patients, the degree to ...
Tapper EB, Serper M, Goldberg DS.
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Randomized in error in pragmatic clinical trials. [PDF]
Contemp Clin TrialsPragmatic trials that combine electronic health record data and patient-reported data may be subject to selection bias due to the differential post-randomization exclusion of participants who are randomized in error. Such situations are often caused by inevitable reasons, such as incomplete patient medical records at the pre-randomization stage.
Tong G, Coronado GD, Li C, Li F.
europepmc +3 more sources
International Journal of Population Data ScienceThe randomized clinical trial framework has proven to be a robust way of evaluating and comparing medications and procedures for many years. The promise of measured and unmeasured balance and equipoise through randomization remains very appealing ...
Jeff Bakal +2 more
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Empirical research related to the ethics of pragmatic clinical trials: A scoping review [PDF]
Learning Health SystemsBackground Pragmatic clinical trials (PCTs) offer insights into real‐world intervention effectiveness, but they may involve challenging ethical issues. Empirical ethics research may inform deliberations about them.
Kayla R. Mehl +2 more
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Data monitoring committees for pragmatic clinical trials [PDF]
Clinical Trials, 2015 In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the ...
Susan Ellenberg +2 more
exaly +5 more sources
Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies [PDF]
Trials, 2023 Background With recent growth in the conduct of pragmatic clinical trials, the reliance on frontline staff to contribute to trial-related activities has grown as well.
Lisa A. Juckett +2 more
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Pragmatic Clinical Trials: The Ethics of Conducting Research in the Real World. [PDF]
Mayo Clin ProcVaszar LT +3 more
europepmc +3 more sources
Independence estimators for re-randomisation trials in multi-episode settings: a simulation study
BMC Medical Research Methodology, 2021 Background Re-randomisation trials involve re-enrolling and re-randomising patients for each new treatment episode they experience. They are often used when interest lies in the average effect of an intervention across all the episodes for which it would
Brennan C. Kahan +3 more
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Ethical considerations for sharing aggregate results from pragmatic clinical trials [PDF]
Clinical TrialsStephanie Morain +2 more
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