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 group- or cluster-randomization designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.
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 19, 2018. At a Research Priorities Workshop in March 2018, meeting attendees will use the input to set research priorities that will drive the development of the All of Us research platform and associated tools.
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 are not credible and are considered predatory; they may have misleading pricing, fraudulent editorial boards, and inadequate (or nonexistent) peer-review processes.
“In support of public access to National Institutes of Health (NIH) funded research, authors are encouraged to publish their results in reputable journals. The NIH has noted an increase in the numbers of papers reported as products of NIH funding which are published in journals or by publishers that do not follow best practices promoted by professional scholarly publishing organizations.”
There are a number of resources available to authors to help identify reputable journals:
- Directory of Open Access Journals lists high quality, peer-reviewed, open-access journals.
- The Principles of Transparency and Best Practices in Scholarly Publishing—developed by The World Association of Medical Editors (WAME) in collaboration with other professional associations—provides recommendations and best practices for medical journal editors.
- Think Check Submit provides guidance for authors on choosing the best journal.
- Statement on Article Publication Resulting from NIH Funded Research
For more information on disseminating results from pragmatic clinical trials see the Living Textbook Chapters:
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 members have contributed to new knowledge through white papers and chapters in the Living Textbook. In the coming years, he’s hoping the Core will be able to identify the value proposition of PROs.
“Because there are costs associated with collecting PROs, we need to determine when PROS are essential, supporting, or not at all informative for the clinical questions. This gets at the value proposition: When are they of value and to whom?” —Dr. Kevin Weinfurt.
Read more from Dr. Weinfurt in the full interview (pdf).
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 treatment is really better.” —Greg Simon, MD
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
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 the chapter, the authors expand on the ideas presented in the Annals article and fame them using lessons learned from the Collaboratory’s Demonstration Projects. Data collected as part of research embedded in a health system comes from a fundamentally different context than stand-alone explanatory trials. When they are taken out of context or used for comparisons, they have the potential to do harm—something that can potentially discourage health systems from volunteering to participate in embedded research. The authors suggest that data sharing plans for embedded research be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.
“Ultimately, it’s a practical question: if we want healthcare providers and healthcare systems to participate in research, we shouldn’t expect them to bear extra risk. In an ideal world, all information about the quality of health care and healthcare outcomes across the country would be completely open to everyone, but we don’t live in that world now. So if we are asking healthcare providers and healthcare systems to open up and be more transparent by participating in research, we certainly would not want to punish those who volunteer.” — Simon et al. in video for Ann Intern Med
Simon G, Coronado G, DeBar L, et al. Data Sharing and Embedded Research: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://www.rethinkingclinicaltrials.org/data-share-top/data-sharing-and-embedded-research-introduction/. Updated November 13, 2017.
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 sites, do training at the sites and with the team, and take field notes in real time. ”
Read more from Dr. Zatzick in the full interview.
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 intervention is seeking to achieve is consistent with their mission. Your outcome goal should be something they care about.”
Read more from Dr. Mor in the full interview.
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, Effectiveness And Research (CLEAR)—will investigate the effectiveness of interventions such as imagining tests, physical therapy, opioids, spine injections, and spine surgery, as well as approaches for implementation. The National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are funding the 5-year, $3.7 million initiative, which will include pragmatic and comparative effectiveness trials and Core groups, including:
- The Methodology Core, led by Patrick J. Heagerty PhD, Chair of the Department of Biostatistics, and Sean Mooney PhD, Professor of Biomedical Informatics and Chief Research Information Officer
- The Resource Core, led by Janna Friedly MD, Associate Professor of Rehabilitation Medicine, and Danielle Lavallee PharmD PhD, Research Associate Professor of Surgery
Dr. Jarvik is a Professor of Radiology at University of Washington and the Principal Investigator the Collaboratory Demonstration Project, the Lumbar Imaging with Reporting of Epidemiology (LIRE) trial.