The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Richard Platt of Harvard Pilgrim Health Care Institute and Dr. Christopher Granger of Duke University. In this episode, Drs. Platt and Granger speak with moderator Dr. Adrian Hernandez about the IMPACT-AFib atrial fibrillation trial and ...

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Greg Simon, principal investigator on the Suicide Prevention Outreach Trial (SPOT), and Dr. Susan Ellenberg of the Regulatory/Ethics Core. In this episode, Drs. Simon and Ellenberg discuss the need for a data and safety monitoring plan in any clinical ...

Publication in journals is an essential part of the scientific process, an important metric for scholarly career advancement, and an integral aspect of grant approval and funding mechanisms. Pressure to publish has engendered a global industry of open access journals, which are driven by author publication fees rather than subscription services. Some of these journals ...

We recently asked Dr. Kevin Weinfurt, Chair of the Patient-Reported Outcomes (PRO) Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. He says the biggest impact of the Core has been working with national initiatives to improve inclusion of PROs in the electronic health record (EHR). Further, Core ...

In a new video in the Living Textbook, Dr. Greg Simon describes the differences between individual, cluster, and stepped-wedge randomization using props, including marbles, Play-Doh, and glassware. “In the end, it’s all about randomly assigning who gets which treatment, or who gets which treatment when, so that we’re able to make some un-biased judgement about which ...

In a new video for the Living Textbook, Dr. Greg Simon uses props—including Play-Doh and toys—to define pragmatic trials and their importance in clinical research. “Pragmatic clinical trials are about helping doctors make better decisions to take care of their patients.” —Greg Simon, MD

The NIH Collaboratory is pleased to announce that the next episode of the Grand Rounds podcast is posted, featuring podcast moderators Dr. Adrian Hernandez and Dr. Kevin Weinfurt. In this episode, Drs. Hernandez and Weinfurt discuss their visions for the future of the NIH Collaboratory, and specifically how past NIH Collaboratory Trials might inform future pragmatic ...

We recently asked Drs. Jeremy Sugarman and Kevin Weinfurt, Co-chairs of the Ethics and Regulatory Core, to reflect on the first 5 years of the Core as well as on the challenges ahead. The regulatory and ethical landscape for pragmatic clinical trials was not well defined when the Core began 5 years ago, and the ...

As part of an article published in Annals of Internal Medicine, Dr. Greg Simon created a short video in which he describes concerns related to data sharing and embedded research, as well as potential solutions for those concerns. We recently added this video to the Living Textbook chapter on Data Sharing and Embedded Research. In ...

In this interview, Dr. Eric Larson, Executive Director of Kaiser Permanente Washington Health Research Institute, and Chair of the NIH Collaboratory Health Care Systems Interactions Core, discusses how working effectively with a health care system can maximize the chances of running a successful pragmatic trial. He also notes that creating a research question that aligns with the ...

In the final segment of their 2-part video interview, Cathy Meyers, MD, and Wendy Weber, PhD, MPH, of the National Center for Complementary and Integrative Health (NCCIH), reflect on challenges experienced during the first 5 years of the NIH Collaboratory program, such as ethical and regulatory issues of pragmatic clinical trials. They also share a ...

In part 1 of a new 2-part video interview, Cathy Meyers, MD, and Wendy Weber, PhD, MPH, of the National Center for Complementary and Integrative Health (NCCIH), discuss the accomplishments of the NIH Collaboratory in its first 5 years and what to expect in the next phase of the program. Dr. Meyers is the NIH ...

The NIH Collaboratory is pleased to announce that the third episode of the Grand Rounds podcast is posted. In this episode, Dr. Greg Simon discusses the Suicide Prevention Outreach Trial (SPOT), and its implications for machine learning  in predicting suicide attempts and deaths. Dr. Simon describes how the use of computer algorithms to identify specific variables can help predict certain ...

In this interview, Dr. Miguel Vazquez gives an update on the first years of the Improving Chronic Disease Management with Pieces (ICD-Pieces) trial. Dr. Vazquez discussed the status of his trial, challenges and surprises, and advice he has for new investigators. “Try to really learn from others who have done this—even if you are the first ...

In the second installment of a 2-part video interview, former NCCIH Director Josephine Briggs, MD, and former FDA Commissioner Robert Califf, MD, reflect on lessons learned from implementing the NIH Collaboratory’s innovative oversight model and discuss how those lessons can be applied in broader contexts. We’ll be releasing more video interviews with NIH Collaboratory leadership in ...

In part 1 of a new 2-part video interview, former NCCIH Director Josephine Briggs, MD, (retired October 2017) and former FDA Commissioner Robert Califf, MD, revisit the NIH Collaboratory’s beginnings and survey the first 5 years of Collaboratory support for pragmatic clinical research. Together, they reflect on progress made and discuss future challenges and opportunities ...

The conduct of pragmatic clinical trials embedded in health systems where individuals typically receive medical care raises ethical questions regarding the most appropriate ways to protect these individual’s rights, welfare, and interests. In a new article, Dr. Kevin Weinfurt and colleagues compare different models for notification and authorization to determine how acceptable these approaches are ...

In this interview, Dr. Doug Zatzick gives an update on the first years of the Trauma Survivors Outcomes and Support (TSOS) trial. Dr. Zatzick discussed the status of his trial, challenges and surprises, and advice he has for new investigators. Dr. Zatzick’s advice: “Embed implementation teams within embedded trials. The bottom line is, go to the ...

In a new video interview, NIH Collaboratory Coordinating Center co-Principal Investigator Adrian Hernandez, MD, MHS, discusses current challenges and future priorities for pragmatic trials with former FDA Commissioner Robert Califf, MD. Dr. Califf, who also served as the original Collaboratory Coordinating Center Principal Investigator, offers his perspectives on the key roles that data science, analytics, ...

In a new video interview, NIH Collaboratory Coordinating Center co-principal investigators, Kevin Weinfurt, PhD, Lesley Curtis, PhD, and Adrian Hernandez, MD, MHS, discuss the next phase of the NIH Collaboratory program, including what they are most excited about and what success would look like over the next 5 years. We’ll be releasing more video interviews with ...

In this interview, Dr. Vincent Mor gives an update on the first years of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) project. Dr. Mor discussed the status of his trial, challenges and surprises, and advice he has for new investigators. Dr. Mor’s advice: “The health care system must agree that the outcome your ...

We recently asked Dr. Liz DeLong, Chair of the Biostatistics and Study Design Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. She says the biggest impact of the Core has been working with the individual NIH Collaboratory Trials to provide a sounding board to discuss statistical challenges. ...

At the NIH Collaboratory Steering Committee meeting in May 2017, we asked Ellen Tambor, a member of the Stakeholder Engagement Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. She says it’s key for stakeholder engagement to take place throughout the entire healthcare system, from leadership to the ...

Congratulations to Dr. Jeffrey Jarvik and his colleagues at the University of Washington for their recent grant award to establish the Core Center for Clinical Research (CCCR). The initiative will promote pragmatic, multi-institutional clinical research on musculoskeletal conditions, such as the diagnosis and treatment of back pain. The new center—the UW Center for Clinical Learning, ...

At the NIH Collaboratory Steering Committee meeting in May 2017, we asked Drs. Rachel Richesson and W. Ed Hammond, Co-chairs of the Phenotypes, Data Standards, and Data Quality Core, to reflect on the first 5 years of their Core’s work and the challenges ahead. Both were pleased with how the Core was able to provide guidelines ...

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 ...

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 ...

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 ...

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 ...

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 NIH Collaboratory Trials.  The authors highlight some of the challenges encountered and solutions developed and discuss remaining barriers and opportunities for large-scale evidence generation ...

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 NIH Collaboratory Trials that embed innovative pragmatic clinical research within the “real-world” ...

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 ...

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.

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.

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.

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.

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).

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.

​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.

Do you have a question about the rates of medical conditions or the frequency of use of medical and surgical treatments?

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.

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.

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).

In a recent segment on NPR’s Morning Edition, commentators discuss the potential of using electronic health records to customize medical treatments.

Research on medical practices (ROMP) includes medical record reviews, comparative effectiveness research, quality improvement interventions, and point-of-care randomization, and may improve the efficiency, quality, and cost-effectiveness of medical care. In a study by Maureen Kelly and colleagues recently published in The American Journal of Bioethics, researchers found that patients may not fully understand the rationale for ...

On June 19, 2014, the NIH Common Fund is celebrating 10 years of achievement with a symposium, A Decade of Discovery, featuring its far-reaching research. Dr. Robert Califf, principal investigator of the NIH Collaboratory Coordinating Center, will speak during the 2:15-3:15 pm session “Reengineering the Clinical Research Enterprise.” Proceedings will be streamed live throughout the ...

A series aired on American Public Media’s Marketplace program profiled real-world examples of using healthcare data to improve care and reduce costs in Camden, NJ. 1. Using data to treat the sickest and most expensive patients 2. Data: The secret ingredient in hospital cooperation 3. Data opens doors in healthcare, but then what? The first segment follows Dr. Jeffrey ...

Today, May 20th, is International Clinical Trials Day, which  marks the anniversary of what is generally believed to be one of the world’s first controlled clinical trials. In 1747, Scottish naval surgeon James Lind had undertaken what at the time constituted a daring experiment to find a treatment for scurvy, a disease caused by vitamin ...

In a commentary published this week in the journal Nature and featured in the New York Times, NIH Director Dr. Francis Collins unveiled new NIH policies that will require balanced inclusion of male and female cells and animals in NIH-funded preclinical research (with few defined exceptions). Though inclusion of women in NIH-funded clinical trials has ...

As part of its 10-year commemoration activities, the NIH Common Fund is holding a video and song competition to showcase Common Fund–supported activities in a fun and creative way. Grantees and program staff were encouraged to submit brief, original works that would be accessible and engaging to the public. The video entries have been posted, and ...