Privacy and confidentiality in pragmatic clinical trials [PDF]
With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice ...
Deven Mcgraw, Alan Rubel
exaly +3 more sources
Randomized in error in pragmatic clinical trials. [PDF]
Pragmatic 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
The 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
doaj +2 more sources
Empirical research related to the ethics of pragmatic clinical trials: A scoping review [PDF]
Background 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
doaj +2 more sources
Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies [PDF]
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
doaj +2 more sources
Collection of implementation-related data in pragmatic clinical trials: a cross-sectional study from the NIH Pragmatic Trials Collaboratory [PDF]
Background Embedded pragmatic clinical trials (ePCTs) are conducted as part of routine care, which provides researchers and health systems multiple opportunities to study implementation processes and outcomes.
Katy E. Trinkley +9 more
doaj +2 more sources
Pragmatic Clinical Trials: The Ethics of Conducting Research in the Real World. [PDF]
Vaszar LT +3 more
europepmc +2 more sources
Independence estimators for re-randomisation trials in multi-episode settings: a simulation study
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
doaj +1 more source
What Is a Pragmatic Clinical Trial? [PDF]
Pragmatic trials Pragmatic clinical trials seek to determine the effectiveness of an intervention in a real-world setting to inform clinical decision making (Roland and Torgerson, 1998). Researchers designing pragmatic trials take particular care to ensure that the study population is as similar as possible to the population on which the intervention ...
Williams, Hywel C. +2 more
openaire +2 more sources
Gatekeepers for pragmatic clinical trials [PDF]
To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the ...
Danielle M, Whicher +3 more
openaire +2 more sources

