“Ethics and Regulatory Complexities for Pragmatic Clinical Trials,” a Viewpoint article by Jeremy Sugarman, MD, MPH, MA, and Robert Califf, MD, was published online in JAMA today. In the article, the authors draw on early experiences from two large networks conducting pragmatic clinical trials, the NIH Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), to describe 10 ethical and regulatory complexities facing this new field of research. Topics covered include informed consent, risk determination, the role of gatekeepers, and institutional review board review and oversight, among others, as well as the ongoing need for further discussion and research as a key part of efforts aimed at creating a learning healthcare system.
Dr. Sugarman is chair of the Regulatory/Ethics Core of the NIH Collaboratory and deputy director for medicine of the Johns Hopkins Berman Institute of Bioethics. Dr. Califf is the principal investigator of the NIH Collaboratory Coordinating Center and director of the Duke Translational Medicine Institute.
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 voting will be open until May 9. View the videos on YouTube and “like” your favorites to vote. Videos from NIH Collaboratory investigators and committee members include:
Song entries are still being screened.
Winners will receive recognition at the Common Fund 10-Year Commemoration Symposium in June 2014, where NIH Director Dr. Francis Collins will perform the winning song.
Slides and a workshop summary are now available from the Institute of Medicine website.
On April 23-24, 2014, the Institute of Medicine held a Roundtable on Value & Science-Driven Health Care workshop titled “Health System Leaders Working Towards High Value Care Through Integration of Care and Research” in Washington, DC. The workshop, sponsored by the Patient-Centered Outcomes Research Institute (PCORI), brought together stakeholders from across research networks, health systems, industry, and the patient community to engage on barriers and opportunities in building a continuously learning health system, where routinely collected health data informs improvements in evidence-based care. Eric Larson, MD, MPH, of the Group Health Research Institute chaired the workshop Planning Committee.
Workshop goals included:
- Fostering the development of a shared commitment, vision, and strategy among health system leaders building a national clinical research network
- Broadening and deepening health systems’ leadership awareness of the prospects for and from a continuously learning health system
- Learning from models and examples of productive integration of research with care delivery programs
- Identifying common issues compelling to health systems leaders related to science, technology, ethics, regulatory oversight, business, and governance
- Exploring strategic opportunities for executive, clinical, and research leaders to forge working partnerships for progress
- Considering the approach and desirable outcomes of a meeting of CEO leaders vital to building and sustaining a functional, real-time national clinical research network
One particular focus of the meeting was the recently launched National Patient-Centered Clinical Research Network (PCORnet). Workshop participants included representatives from PCORnet’s Clinical Data Research Networks and Patient-Powered Research Networks. Speakers provided real-world examples of learning health systems and urged leaders to make a business case for the learning health system model. Speed and dissemination of research were discussed as important considerations for patients.
The meeting was open to the public via webcast. Archived meeting presentations will be made available; a link will be provided in an update to this post. Workshop-related tweets can be found with the hashtag #IOMPCORI.
View the workshop agenda and briefing materials.
The Meta-Research Innovation Center at Stanford (METRICS) is a new research-to-action center that will conduct meta-research or “research on research” with the goal of optimizing the reproducibility, efficiency, and quality of scientific investigations. Funded by a grant from the Laura and John Arnold Foundation, its efforts will apply to all scientific research, not just medical research.
METRICS is co-directed by John P.A. Ioannidis, MD, DSc, and Steven N. Goodman, MD, MHS, PhD. The center will fund scholars in meta-research and foster worldwide collaborations “to study how research is done, how it can be done better, and how to effectively promote and incentivize the use of best scientific practices.” Additional details can be found on the Stanford School of Medicine website.
Archived video and slides from the April 25 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.
This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives”) will be presented by Cynthia Hahn and Petra Kaufmann, MD, MSc, team leaders for the Clinical Trials Transformation Initiative’s Central IRB Advancement Project. Ms. Hahn is vice president of Clinical Research & Regulatory Affairs for the Feinstein Institute for Medical Research. Dr. Kaufmann is director of the Office of Clinical Research for the National Institute of Neurological Disorders and Stroke.
CTTI’s Central IRB Advancement Project is a follow-up to its previous Central IRB Project that conducted expert and stakeholder interviews to produce considerations and recommendations for central IRB adoption. The current project will take additional steps in encouraging the implementation of these recommendations and addressing remaining barriers to further advance the use of central IRBs for multicenter clinical trials. Expected deliverables include tools and best practices for researchers, sponsors, sites, and IRBs.
The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 25. Details are available here. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.
Archived video and slides from the April 18 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.
This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“Building PCOR Value and Integrity With Data Quality and Transparency Standards: An Introduction and Request for Input”) will be presented by Michael G. Kahn, MD, PhD, professor of epidemiology in the Department of Pediatrics at the University of Colorado Denver. Dr. Kahn is co-director of the Colorado Clinical and Translational Sciences Institute (CCTSI), Translational Informatics Core director for the CCTSI, and director of clinical informatics in the Department of Quality & Patient Safety at The Children’s Hospital.
The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 18. Details are available here. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.
Archived video and slides from the April 11 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.
Today’s NIH Collaboratory and PCORnet Grand Rounds (“A PCORnet Update”) will be presented by Richard Platt, MD, MSc, professor and chair of the Department of Population Medicine at Harvard Pilgrim Health Care Institute. Dr. Platt is co-principal investigator of the Coordinating Center for the NIH Collaboratory, principal investigator of the Coordinating Center for PCORnet, and principal investigator of the FDA’s Mini-Sentinel program.
The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 11. Details are available here. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.