News
- October 5, 2017: NIH Collaboratory Launches Grand Rounds Podcast The NIH Collaboratory is excited to announce the launch of a new podcast that is based on the popular Grand Rounds webinar series. At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts. The first two podcasts ...
- October 3, 2017: New Collaboratory Article Explores Data Sharing and Embedded Research In an article published in Annals of Internal Medicine, authors from the NIH Collaboratory describe concerns and solutions regarding data sharing and embedded research. Pragmatic research embedded in health systems uses data from the electronic health record and comes from a fundamentally different context than explanatory trials, which collect research-specific data. Data from embedded research ...
- October 2, 2017: New multi-agency initiative modeled on NIH Collaboratory to focus on non-drug approaches to managing chronic pain in U.S. service members and veterans. A new research project modeled on the NIH Health Care Systems Research Collaboratory has been created to investigate non-drug approaches to helping U.S. service members and veterans manage chronic pain. The U.S. Department of Health and Human Services, the U.S. Department of Defense (DoD), and the U.S. Department of Veterans Affairs (VA) jointly announced the ...
- September 27, 2017: Charter Template for Data Monitoring Committees for Pragmatic Clinical Trials Now Available The NIH Collaboratory Regulatory/Ethics Core has published a charter template that can be used to help establish a data monitoring committee (DMC) and associated procedures appropriate for oversight of pragmatic clinical trials. DMCs play an important role in protecting the welfare of trial participants and ensuring the integrity of a trial so that it can ...
- September 21, 2017: New Article Highlights Generalizable Lessons Learned from the NIH Collaboratory In a new article in BMC Medical Research Methodology, Dr. Kevin Weinfurt and colleagues share generalizable lessons learned from the first four years of the Collaboratory and their experiences with the Demonstration Projects. The authors highlight some of the challenges encountered and solutions developed and discuss remaining barriers and opportunities for large-scale evidence generation using ...
- September 19, 2017: The NIH Health Care Systems Research Collaboratory Turns Five! Five years ago this September marks the birth of the NIH Health Care Systems Collaboratory, an NIH Common Fund project designed to build national infrastructure for conducting pragmatic clinical trials (PCTs). At the heart of the NIH Collaboratory is an ongoing series of Demonstration Projects that embed innovative pragmatic clinical research within the “real-world” conditions ...
- August 25, 2017: NIH Collaboratory Launches New Website With Expert Insight on Pragmatic Trials Today, the NIH Collaboratory launched its new website, Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. The updated website serves as the new home for comprehensive information about the NIH Collaboratory program, as well as a rich source of knowledge about special considerations for pragmatic clinical trials at each step of the research ...
- July 28, 2017: FDA says will not object to waiver of informed consent for minimal risk studies in new guidance In a new guidance, the US Food and Drug Administration (FDA) explains that it does not intend to object to the conduct of a minimal risk clinical study if the institutional review board has waived or altered the requirement for informed consent.
- July 6, 2017: New article compares different approaches for notification and authorization in pragmatic clinical research Dr. Kevin Weinfurt and colleagues in the Regulatory/Ethics Core of the NIH Collaboratory recently published an article in the American Journal of Bioethics regarding how acceptable different approaches to notification and authorization are to potential participants in pragmatic research.
- June 12, 2017: New article from the Collaboratory’s PRO Core published in eGEMs In a new article in eGEMs, the NIH Health Care Systems Research Collaboratory’s Patient-Reported Outcomes (PRO) Core gathered first-hand experiences on the incorporation of PROs for both care and research.
- April 18, 2017: New Foundation Established to Advance the Sustainability of PCORnet In March 2017, a new nonprofit organization was set up to support the vision and successes of PCORnet, the National Patient-Centered Clinical Research Network.
- March 14, 2017: New Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records A multidisciplinary team at Johns Hopkins University has produced a draft users’ guide that focuses on best practices for integrating (PROs) in electronic health records (EHRs).
- March 14, 2017: Collaboratory Authors Publish a Perspective on Pragmatic Trial Informatics in JAMIA Members of 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) and proposing policy and research actions to facilitate the future conduct of PCTs.
- March 7, 2017: Perspective: Clinician Engagement for Continuous Learning The National Academy of Medicine (NAM) has published a new discussion paper that advances the vision of a continuously learning health system, which the Institute of Medicine laid out in the 2013 report Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.
- January 25, 2017: NIH Collaboratory Invites Requests to Query the Distributed Research Network Do you have a question about the rates of medical conditions or the frequency of use of medical and surgical treatments?
- January 24, 2017: New Online NIH Course on Pragmatic and Group-Randomized Trials 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.
- January 18, 2017: DHHS and 15 other agencies announce changes to Common Rule The Department of Health and Human Services and 15 other agencies have announced revisions to the Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule.
- January 11, 2017: NIH Technical Assistance Videocast for Researchers January 24 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).
- January 10, 2017: Use of Data from Electronic Health Records to Customize Medical Treatments In a recent segment on NPR’s Morning Edition, commentators discuss the potential of using electronic health records to customize medical treatments.