October 11, 2017: New grant awarded to Dr. Jeffrey Jarvik and his team of investigators to promote pragmatic musculoskeletal clinical research

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.

 

Recent Collaboratory Publications on Research Ethics


The American Journal of Bioethics has recently published three articles authored by members of the Regulatory/Ethics core group describing various questions related to research on medical practices:

  • Is shared decision making an appropriate analytic frame for research on medical practices (Sugarman 2015) discusses the role of shared decision making (SDM) in research on medical practices. The author cautions that “while SDM is in many ways similar to informed consent, there are some important differences, especially in the research setting.” This publication is freely accessible through PubMed Central.
  • Patients’ views concerning research on medical practices: implications for consent (Weinfurt et al. 2015) describes the results of focus group sessions that elicited a range of patients’ views and opinions about different types of research on usual medical practices. The authors state that “our data suggest that effective policy and guidance will involve balancing different patients’ interests and potentially different sets of interests for different types of research studies on usual medical practices.”
  • Ethics of research in usual care settings: data on point (Sugarman 2016) introduces a special five-article supplement in the American Journal of Bioethics, stating that the “growing empirical ethics literature regarding research in usual care settings provides data to inform conceptual and policy debates regarding this research and suggests areas that require further study.”

These publications were supported by a bioethics supplement awarded to the Regulatory/Ethics Core group by the NIH’s Office of the Director.


Office for Human Research Protections Releases Draft Guidance on Disclosing Risks in Standard-of-Care Research


On October 20, 2014 the Office for Human Research Protections (OHRP) released a draft guidance on how to apply the Department of Health and Human Services (HHS) regulations on protecting human subjects (45 CFR Part 46) who participate in research studies intended to evaluate risks of treatments or procedures commonly used by healthcare professionals and recognized as “standard of care.” In standard-of-care research (or comparative effectiveness research), participants are randomized to receive one of two (or more) treatments that are accepted by medical experts as appropriate treatments for a given disease or condition.

Because treatments assigned to some participants might be different than the treatments they would have been assigned if they were not participating in the study, and the risks associated with one treatment might be different from the risks associated with another treatment, the OHRP recommends that these risks be fully described to potential participants as a part of the informed consent process.

Click here for the full draft guidance: Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

The Institute of Medicine is planning a two-day public workshop in December to discuss human subjects protections in standard-of-care research. Click here for more information.​


 

The Diane Rehm Show Features PCORnet


On Thursday, April 17, The Diane Rehm Show, a nationally syndicated news and call-in program carried on National Public Radio, aired a program titled The Promise and Perils of a New Project to Share Individual Patient Records. Susan Page of USA Today led the discussion on PCORnet: the National Patient-Centered Clinical Research Network, which is supported by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Joe Selby, the executive director of PCORI, describes how PCORnet will take advantage of the incredible quantity of clinical information in electronic health records to conduct much-needed research on the relative effectiveness of different medical devices, drugs, and other medical therapies. Click here for a transcript of this program, or listen to the full episode below:

Listen now: The Promise and Perils of a New Project to Share Patient Records


PCORI Featured in Health Affairs Blog


Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), discusses the promise of PCORI’s research efforts in a recent guest blog post for healthcare policy journal Health Affairs. In his post, Selby explains that PCORI’s mandate is not just to fund comparative effectiveness research (CER) studies that compare multiple therapeutic options, but also to share the results in ways that are meaningful to patients, physicians, and other stakeholders.

Although many of PCORI’s resources are dedicated to supporting CER in reaPatient-Centered Outcomes Research Institute (PCORI) logol-world settings, patient engagement in research is also a cornerstone of PCORI’s efforts. Of the $464 million invested, 62% has been focused on CER, with the rest spread across infrastructure (18%), methods (11%) and communication and dissemination research (8%). PCORI expects to commit $1 billion over the next 2 years to expand their work. As part of their mission, they also hope to improve research methods and build the national capacity for CER.


Grand Rounds (3-26-2014): Why Is the FDA Interested in the Collaboratory and PCORnet?

Update:

Archived video and slides  from the March 26 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

Photograph of FDA CDER Director Janet Woodcock, MD
CDER Director Janet Woodcock, MD. Photo credit: FDA

The guest speaker for this Friday’s Collaboratory/PCORnet Grand Rounds presentation will be the FDA’s Janet Woodcock, MD. Dr. Woodcock is the current director of the Center for Drug Evaluation and Research (CDER), the division of the FDA primarily responsible for evaluating the safety and effectiveness of both prescription and over-the-counter drugs and biologic therapies marketed in the United States.

The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, March 26. Details are available here. Archived video and slide sets from the presentation will be available early the following week; links to archived material will be provided in an update to this post.


STOP CRC Study Featured on NPR Health Blog


The Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study was recently featured on National Public Radio’s Shots Blog, which is devoted to coverage and discussion of health and healthcare issues.

Picture of U.S. stop sign.
Public-domain image via Wikimedia Commons.

STOP CRC, which is exploring innovative approaches for increasing colon cancer screening rates among low-income and minority populations, is one of the seven UH2 pilot projects supported by the NIH Collaboratory. The demonstration phase of the project will be conducted within a pair of health centers that are part of OCHIN, a community-based network of Federally Qualified Health Centers.

More information about about STOP CRC is available here.