The Agency for Healthcare Research and Quality (AHRQ) is requesting information to help inform a competition in the fall to develop and implement user-friendly technical tools for the collection of patient-reported outcome (PRO) data. The AHRQ is interested in learning about experiences with physical function PRO measures that are currently in use in ambulatory care ...

The FDA is conducting a public workshop on Monday, March 19, to obtain input from stakeholders—including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons—to inform the drafting of a patient-focused drug development guidance as required by the 21st Century Cures Act. Workshop attendees will discuss considerations for development ...

A recently released summary from the ADAPTABLE Roundtable Meeting explores ways to better understand the sets of circumstances and considerations that could guide when and how to gather and integrate patient-reported health data with other data sources in pragmatic trials. For outcomes that represent subjective experiences, such as pain, symptoms, and physical functioning, the patient is ...

On February 20-21, 2018, a group of 27 clinical investigators met in Durham to learn from the NIH Collaboratory about the design and conduct of embedded pragmatic clinical trials (ePCTs). Through the experiences of the NIH Collaboratory, much has been learned about how to launch and implement successful ePCTs. The workshop’s goal was to help ...

The National Academies of Sciences, Engineering, and Medicine released a summary of the first workshop in a 3-part series on the development and use of real-world evidence in medical product development. The report, Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives, focuses on the role of incentives in supporting the collection ...

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Andrew Faucett of Geisinger. In this episode, Dr. Faucett speaks with moderator Dr. Lesley Curtis about the scalability of returning genomic research to clinicians and patients, considering issues like technical validity and sample identity in genetic variants. He also ...

The NIH Collaboratory will soon welcome a new group of NIH Collaboratory Trials and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)­—to share tips and advice for investigators ...

The NIH Collaboratory is pleased to announce that Grand Rounds podcasts are now available on iTunes. These podcasts aim to give listeners a deeper understanding of topics discussed during Grand Rounds presentations through interviews with the speakers. Topics covered in past episodes include the IMPACT-Afib trial and the role of Sentinel, data and safety monitoring ...

In the spring of 2018, the NIH Collaboratory will be welcoming a new set of NIH Collaboratory Trials and will help shepherd the new pragmatic trials through the piloting and implementation phases of their studies. In a new video in the Living Textbook, two of our seasoned principal investigators—Drs. Susan Huang and Gloria Coronado—give advice ...

One of the Clinical Effectiveness Research Innovation Collaborative (CERIC) group’s priority actions is to create a supportive regulatory environment for learning activities that aim to provide evidence for healthcare improvement. In support of this goal, the National Academy of Medicine hosted a day-long meeting on January 25, 2018, to propose and communicate streamlined approaches for ...

Want to know more about the goals and challenges of the NIH Collaboratory’s NIH Collaboratory Trials? New downloadable handouts summarize the study aims, implementation lessons, and recent publications and presentations from these innovative pragmatic clinical trials. Study Snapshots are accessible from each NIH Collaboratory Trial page and the links below: Active Bathing to Eliminate (ABATE) Infection Collaborative Care ...

The NIH Collaboratory is pleased to announce the launch of its new monthly email newsletter. The newsletter offers a convenient monthly wrap-up of NIH Collaboratory news, along with featured stories and a look at what’s coming in the month ahead. Every newsletter will contain useful tips for investigators and links to resources for pragmatic clinical ...

Patient-reported outcome (PRO) data are critical for informing patient-centered care and patient-centered outcomes research, although they are not commonly collected in routine care, and are often not available for use in clinical care or research. To counter this problem, the Agency for Healthcare Research and Quality (AHRQ) announced an upcoming competition to develop tools to ...

The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As ...

On January 17, 2018, the Department of Health and Human Services and 15 other federal departments and agencies announced a delay to both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). Most provisions in the revised Common Rule were ...

The groundbreaking “All of Us” research program, which aims to enroll and track more than a million people, is asking prospective researchers, community organizations, and citizen scientists for suggestions regarding potential research questions. Ideas can be submitted through a special research page and are due by February 23, 2018. At a Research Priorities Workshop in ...

The National Cancer Institute’s Division of Cancer Control & Population Sciences is accepting applications for a Training Institute in Dissemination and Implementation Research in Cancer (TIDIRC). Designed for investigators at all levels who conduct dissemination and implementation research in cancer control, the training institute will consist of a 4-month online course and a 2-day in-person ...

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.