December 11, 2018: Two New NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced two new funding opportunity announcements (FOAs) for 7 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research.

The two announcements are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

Podcast December 5, 2018: Validating a Computable Phenotype: Should Results Change a Trial’s Pre-Specified Primary Outcome?

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.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

December 3, 2018: FDA Calls for Comments on Proposed Rule to Allow Exceptions to the Requirement for Informed Consent in Minimal-Risk Research

The Food and Drug Administration (FDA) is proposing a rule to allow for a waiver or alteration of informed consent for clinical investigations posing no more than minimal risk to human participants. This rule would align FDA regulations with the Common Rule, reduce burden and costs for Institutional Review Boards, and be expected to lead to advances in healthcare.

“We expect benefits in the form of healthcare advances from minimal risk clinical investigations and from harmonization of FDA’s informed consent regulations with the Common Rule’s provision for waiver of informed consent for certain minimal risk research.” —  Federal Register /Vol. 83, No. 221

Currently, FDA allows a waiver or alteration of consent only in life-threatening situations. If aligned with the Common Rule, a waiver or alteration would be allowed if the IRB finds and documents that 1) the research involves no more than minimal risk, 2) the rights and welfare of subjects will not be adversely affected, 3) the research could not practicably be carried out without a waiver, and 4) the participants will be provided with additional pertinent information after completion of the trial.

Comments on the proposed rule are due by January 14, 2019.

Podcast November 20, 2018: Data Linkage Within, Across, and Beyond PCORnet

Listen to the episode here:

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.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

November 20, 2018: Upcoming NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced an intent to publish new funding opportunity announcements (FOAs) for 5 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. Both FOAs will be published in early December with applications due as early as February 2019.

The two notices are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

November 16, 2018: New Living Textbook Chapter on Team Composition for Pragmatic Trials

Embedded pragmatic clinical trials (ePCTs) are conducted by gathering data during the course of routine care. Accordingly, health care system personnel—not research personnel—will be collecting data and delivering the intervention. A new Living Textbook chapter describes the considerations for team composition to help ensure the success of an ePCT.

“Many different people are involved in the conduct of an ePCT, and when designing a trial, an investigator will need to carefully consider the roles of potential team members, including which roles are essential, and who will fill the roles.”

—Dr. Lesley Curtis in ePCT Team Composition

November 13, 2018: Summary of Workshop on Pragmatic Trials of Therapeutic A vs B Interventions Now Available

The NIH Collaboratory recently convened a workshop to explore embedded pragmatic clinical trials comparing two or more therapeutic medical interventions. These “A vs B” trials are meant to test existing, viable treatment alternatives where there is uncertainty about which treatment is best in which populations. There are unique barriers that make these types of pragmatic trials especially challenging to implement. For the workshop, a panel of experts gathered to discuss challenges and solutions regarding partnering with healthcare systems to conduct the trials, unique legal and ethical issues, and design and operational considerations. The summary of the workshop is now available: Workshop Summary: Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions

 

Additional Resources:

Embedded pragmatic clinical trials of therapeutic A vs. B interventions workshop videocast.

 

November 12, 2018: Participate in the NIH Office of Disease Prevention’s Research Expertise Survey

The National Institutes of Health (NIH) Office of Disease Prevention (ODP) needs your help to enhance the quality of research supported by the NIH. The ODP is building a directory of experts in research methods and study designs that can help NIH Scientific Review Officers identify the most appropriate reviewers for NIH research applications. Adding your name and expertise to the directory is easy – simply share your methodological and content area expertise by filling out the ODP’s Prevention Research Expertise Survey (PRES).


 

The survey covers 7 areas related (but not limited) to prevention research:

  • Study Design Topics
  • Research Methods
  • Content Topics
  • Settings
  • Populations
  • Regions
  • Income Categories

The PRES takes approximately 15-25 minutes and is strictly voluntary. Based on your skill set and interest, NIH or Department of Health and Human Services (HHS) staff may invite you to serve as a peer reviewer for research applications, or you may be asked to sit on a panel, committee, or workgroup; or to speak at a seminar or workshop. Your responses and information will not be shared with anyone outside of HHS.

The ODP believes the participation of highly qualified methods experts will enhance the quality of peer review; improve the rigor, reproducibility, and impact of research supported by the NIH; and ultimately lead to stronger clinical practice, health policy, and community health programs.

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention and disseminating the results of this research to improve public health. For more information about the ODP and its work, visit the ODP website.

Thank you in advance for taking the survey – your participation helps improve the rigor, impact, and value of research supported by the NIH.

Podcast November 7, 2018: MDEpiNet RAPID and SPEED Projects: Leveraging Real World Evidence to Get Better, Faster, Cheaper Medical Devices for Physicians and Patients

In this episode of the NIH Collaboratory Grand Rounds podcast, Renee Mitchell, Terrie Reed, and Roseann White discuss the MDEpiNet RAPID and SPEED Projects. In their conversation with Dr. Adrian Hernandez, Renee, Terrie, and Roseann discuss the concept behind the projects, the collaborative nature, associated challenges, next phases, and the future.

Listen to the episode here:

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.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

November 7, 2018: The NIH-DoD-VA Pain Management Collaboratory Builds on the Success of the NIH Health Care Systems Research Collaboratory

In a new video, Drs. Wendy Weber and Dave Clark discuss the NIH-DoD-VA Pain Management Collaboratory, which is modeled after the NIH Health Care Systems Research Collaboratory. The Pain Management Collaboratory has a centralized Coordinating Center and is supporting a series of 11 pragmatic trials in military and veteran health care delivery organizations focusing on non-pharmacological approaches to pain management.

Dave Clark, Wendy Weber from NIH Collaboratory on Vimeo.

“All of the projects are pragmatic trials done either within the VA or the Military Health System and they all address non-pharmacological approaches to pain management. Our goal is partnering with the VA and the DoD to really see if we can find other ways of managing pain other than opioid medication.” —Dr. Wendy Weber, Acting Deputy Director for the National Center for Complementary and Integrative Health (NCCIH)

This collaboration marks one of the first times the National Institutes of Health (NIH), the U.S. Department of Defense (DoD), and the U.S. Department of Veterans Affairs (VA) have worked together.