FDA says will not object to waiver of informed consent for minimal risk studies in new guidance
July 28, 2017: In a new guidance, the FDA explains that it does not intend to object to the conduct of a minimal risk clinical study if the IRB has waived or altered the requirement for informed consent.
New article compares different approaches for notification and authorization in pragmatic clinical research
July 6, 2017:Dr. Kevin Weinfurt and colleagues in the Regulatory/Ethics Core compare how acceptable different approaches to notification and authorization are to potential participants in pragmatic resarch.
New article from the Collaboratory’s PRO Core published in eGEMs
6/12/2017: The NIH Health Care Systems Research Collaboratory’s Patient-Reported Outcomes (PRO) Core publishes an article in eGEMs on the incorporation of PROs for both care and research.
New Foundation Established to Advance the Sustainability of PCORnet
4/18/2017: The People-Centered Research Foundation is a new nonprofit organization that supports the vision and successes of PCORnet, the National
Patient-Centered Clinical Research Network.
Collaboratory Authors Publish a Perspective on Pragmatic Trial Informatics in JAMIA
3/14/2017: The Collaboratory’s Phenotypes, Data Standards, and Data Quality Core group have published a new article describing the informatics challenges of conducting pragmatic clinical trials (PCTs).
New Users' Guide for Integrating PROs in EHRs
3/14/2017: A draft users’ guide that focuses on best practices for integrating (PROs) in electronic health records (EHRs) is available for public comment through April 7, 2017.
Perspective: Clinician Engagement for Continuous Learning
3/7/2017: : The National Academy of Medicine (NAM) has published a new discussion paper that advances the vision of a continuously learning health system, focusing on actions to foster more active engagement of front-line clinicians.
NIH Collaboratory Invites Requests to Query the Distributed Research Network
1/25/2017: Have a question about the rates of medical conditions or the frequency of use of medical and surgical treatments? The NIH Collaboratory invites you to query its Distributed Research Network.
New Online NIH Course on Pragmatic and Group-Randomized Trials
1/24/2017: The National Institutes of Health’s Office of Disease Prevention (ODP) has released a free, self-paced online course on designing and analyzing pragmatic and group-randomized trials.
Changes to the Common Rule Announced
1/18/2017: DHHS and 15 other agencies announce changes to the Common Rule. Document will be published in the Federal Register January 19, 2017.
Use of Data from Electronic Health Records to Customize Medical Treatments
1/10/2017: In a recent segment on NPR’s Morning Edition, commentators discuss the potential of using electronic health records to customize medical treatments.
NIH FOA Technical Assistance Videocast January 24
1/11/2017: The NIH's Office of Strategic Coordination is holding a live information session regarding its funding opportunity announcement (FOA) "NIH Healthcare Systems Research Collaboratory - Demonstration Projects for Pragmatic Clinical Trials (UG3/UH3)."
Understanding the Potential of Real-World Evidence
12/20/2016: In a recent article in the New England Journal of Medicine, authors propose how the term “real-world evidence” should be understood in order for this type of research to fulfill its potential to inform and improve healthcare.
New NIH Funding Opportunity Announcement to Support Health Care Research Collaboratory Demonstration Projects
12/15/2016: This FOA solicits applications to support Demonstration Projects that include an efficient, large-scale pragmatic clinical trial.
NIH Issues RFI for Opportunities in Suicide Research Using Existing Datasets
11/18/2016: NIMH hass issued a request for information to solicit input on opportunities for using existing datasets in suicide prevention research. Responses are due December 2, 2016.
Recent Collaboratory ethics articles among the most downloaded from AJOB Empirical Bioethics
10/27/2016: Five Collaboratory ethics articles were among the most downloaded since 2014 from AJOB: Empirical Bioethics.
Collaboratory Writing Team Presents at American Medical Writers Association
10/7/2016: At the 2016 American Medical Writers Association conference, the NIH Collaboratory’s writing team led a session for scientific communicators engaged in disseminating findings from pragmatic clinical trials.
LIRE Trial Completes Enrollment
10/3/2016: The Lumbar Imaging with Reporting of Epidemiology (LIRE) trial has completed enrollment. Congratulations to the LIRE study team on this important milestone!
HHS Issues Final Rule for Trials Data Reporting
9/19/2016: The Department of Health and Human Services has released the final rule for registering and reporting results from clinical trials as specified under Section 801 of the Food and Drug Administration Amendments Act (FDAAA) Journal.
NIH Collaboratory ABATE Infection Trial Highlighted in Wall Street Journal
9/15/2016: The ABATE Infection trial, an NIH Collaboratory project led by Dr. Susan Huang, is featured in the September 12 Health section of the Wall Street Journal.
New NIH Collaboratory resource for the transparent reporting of PCTs
9/1/2016: The NIH Collaboratory has developed a tool to assist authors in the complete and transparent reporting of their pragmatic clinical trials (PCTs).
Collaboratory phenotypes paper published in eGEMs special issue
8/17/2016: A recently published special issue of eGEMs explores strategic uses of evidence to transform healthcare delivery systems.
New video highlights the importance of stakeholder advisory boards
8/9/2016: The PATIENTS program at the University of Maryland has produced a brief video on the role of Stakeholder Advisory Boards.