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Ethical and Regulatory Issues in Pragmatic Clinical Trials: Special Issue of Clinical Trials

NIH Collaboratory Rethinking Clinical Trials
Gina Uhlenbrauck. Tools for Research This page provides background and links to a series of 12 articles on the ethics and regulatory...
110 months ago

Integrating Randomized Comparative Effectiveness Research with Patient Care

The New England Journal of Medicine
Clinical trials of interventions in common practice can be built into the workflow of an electronic medical record. The authors review four...
102 months ago

Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

BioMed Central
New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic...
46 months ago

The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting

The BMJ
The stepped wedge cluster randomised controlled trial is a relatively new study design that is increasing in popularity.
118 months ago

A review of international and UK-based ethical guidelines for researchers conducting nontherapeutic genetic studies in developing countries

Nature
This article summarises international and national UK guidelines for designing and implementing nontherapeutic genetic studies with human subjects in...
230 months ago

Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change

Wiley Online Library
While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials,...
9 months ago

Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system

BMC Medical Ethics
We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-...
110 months ago

Investigators have a duty to minimise waste in pragmatic trials

The BMJ
... to minimise waste in pragmatic trials. BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3531 (Published 20 July 2017) Cite this as: BMJ 2017;358:j3531.
88 months ago

Informed Consent

The New England Journal of Medicine
An investigator obtaining informed consent traditionally asks participants to sign a written consent document — an approach that is becoming...
93 months ago

Improving the relevance of randomised trials to primary care: a qualitative study investigating views towards pragmatic trials and the PRECIS-2 tool

BioMed Central
Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic...
60 months ago