Results 11 to 20 of about 1,577,570 (335)

The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory

Trials, 2022
Background The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at ...
Emily C. O’Brien, Jeremy Sugarman, Kevin P. Weinfurt, Eric B. Larson, Patrick J. Heagerty, Adrian F. Hernandez, Lesley H. Curtis   +6 more
doaj   +2 more sources

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

BMC Medical Research Methodology, 2017
Background The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care ...
Kevin P. Weinfurt, Adrian F. Hernandez, Gloria D. Coronado, Lynn L. DeBar, Laura M. Dember, Beverly B. Green, Patrick J. Heagerty, Susan S. Huang, Kathryn T. James, Jeffrey G. Jarvik, Eric B. Larson, Vincent Mor, Richard Platt, Gary E. Rosenthal, Edward J. Septimus, Gregory E. Simon, Karen L. Staman, Jeremy Sugarman, Miguel Vazquez, Douglas Zatzick, Lesley H. Curtis   +20 more
doaj   +2 more sources

The time is now: role of pragmatic clinical trials in guiding response to global pandemics

Trials, 2021
Along with its heavy toll of morbidity and mortality, the coronavirus disease 2019 (COVID-19) pandemic exposed several limitations of the current global research response.
Aws Almufleh, Jacob Joseph
doaj   +2 more sources

Principles and procedures for data and safety monitoring in pragmatic clinical trials

Trials, 2019
Background All clinical trial investigators have ethical and regulatory obligations to monitor participant safety and trial integrity. Specific procedures for meeting these obligations, however, may differ substantially between pragmatic trials and ...
Gregory E. Simon, Susan M. Shortreed, Rebecca C. Rossom, Robert B. Penfold, Jo Ann M. Sperl-Hillen, Patrick O’Connor   +5 more
doaj   +2 more sources

Pragmatic Clinical Trials

Journal of Korean Academy of Nursing, 2022
Ardith Z. Doorenbos, Duckhee Chae
openaire   +3 more sources

Pragmatic clinical trials and the consent process

Research Ethics Review, 2018
Pragmatic clinical trials (PCTs) are a relatively new methodological approach to the execution of clinical research that can increase research efficiency and provide access to unique data.
Blake Murdoch, Timothy Caulfield
doaj   +2 more sources

Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity. [PDF]

Contemp Clin Trials, 2023
BACKGROUND Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the ...
Staman KL, Check DK, Zatzick D, Mor V, Fritz JM, Sluka K, DeBar LL, Jarvik JG, Volandes A, Coronado GD, Chambers DA, Weinfurt KP, George SZ.   +12 more
europepmc   +2 more sources

Ethical considerations for sharing aggregate results from pragmatic clinical trials. [PDF]

Clin Trials
A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials.
Morain SR, Brickler A, Ali J, O'Rourke PP, Spector-Bagdady K, Wilfond B, Rahimzadeh V, Propes C, Mehl K, Wendler D.   +9 more
europepmc   +2 more sources

Ethics challenges in sharing data from pragmatic clinical trials. [PDF]

Clin Trials, 2022
Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges
Morain SR, Bollinger J, Weinfurt K, Sugarman J.   +3 more
europepmc   +2 more sources

Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials? [PDF]

Am J Bioeth, 2023
Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve ...
Garland A, Morain S, Sugarman J.
europepmc   +2 more sources