news 2021

December 20, 2021: NIH Supplemental Funding Available for Bioethics Capacity Building

Posted on by Damon Seils

NIH logoThe NIH announced the availability of an administrative supplement to fund research on ethical considerations related to biomedical research and projects that support capacity building in bioethics.

Over the past 3 years, the NIH Office of the Director has partnered with NIH Institutes and Centers to support projects spanning the wide range of intersections between bioethics and biomedical research. The new funding opportunity applies to both basic and clinical research and supports a variety of research projects, from ethical considerations in emerging technologies to developing capacity to further engage research participants as partners in research. Applications will be accepted until March 17, 2022.

View the official notice.

December 16, 2021: NIH Collaboratory Publishes COVID-19 Checklist for Statistical Analysis Plans in Pragmatic Trials

Posted on by Damon Seils

Thumbnail image of the COVID-19 checklistA new tool from the NIH Collaboratory assists investigators in identifying impacts of the COVID-19 public health emergency on ongoing pragmatic clinical trials. The Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts summarizes impacts on trial conduct that study teams should document, measure, analyze, and report.

The new checklist was developed by the NIH Collaboratory’s Biostatistics and Study Design Core Working Group. Since the beginning of the COVID-19 pandemic, many of the NIH Collaboratory Trials have had to postpone recruitment, alter methods of participant engagement, and modify tools for research assessment and intervention delivery.

The leaders of the Biostatistics Core, Dr. Patrick Heagerty and Dr. Liz Turner, spoke in a recent interview about the impacts of the pandemic on the NIH Collaboratory Trials. Early next year, the Coordinating Center will report the results of a survey of the study teams about their experiences with these impacts.

Download the Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts.

December 15, 2021: This Friday in PCT Grand Rounds, Cybersecurity and Compliance in Clinical Research and Healthcare

Posted on by Damon Seils
Headshot of Dr. Eric Perakslis
Dr. Eric Perakslis

In this Friday’s PCT Grand Rounds, Dr. Eric Perakslis of Duke University will present “Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None.” The Grand Rounds session will be held on Friday, December 17, at 1:00 pm eastern.

Dr. Perakslis is the chief science and digital officer for the Duke Clinical Research Institute and the chief research technology strategist in the Duke University School of Medicine. Join the online meeting.

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

December 13, 2021: BeatPain Utah and GRACE Begin Enrollment in Studies of Nonpharmacologic Pain Management

Posted on by Damon Seils
Headshot of Dr. Julie Fritz
Dr. Julie Fritz, BeatPain Utah

The BeatPain Utah study and the GRACE trial have begun enrollment of study participants. Both projects were awarded continuation into the UH3 implementation phase in the summer. The studies make up the second cohort of NIH Collaboratory Trials to be supported through the NIH HEAL Initiative’s PRISM program.

Congratulations to both study teams for reaching this important project milestone!

BeatPain Utah is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back pain in primary care clinics of federally qualified health centers. Learn more about BeatPain Utah in this interview with principal investigator Dr. Julie Fritz. BeatPain Utah is supported by the NIH through the NIH Heal Initiative under an award from the National Institute of Nursing Research.

The GRACE trial is studying real-world implementation of acupuncture and guided relaxation for patients with pain associated with sickle cell disease. Learn more about GRACE in this interview with co–principal investigator Dr. Robert Molokie. GRACE is supported by the NIH through the NIH HEAL Initiative under an award from the National Center for Complementary and Integrative Health.

Combined headshots of Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah
GRACE co–principal investigators Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah

The PRISM projects—Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing—are studying the real-world effectiveness of nonpharmacologic interventions for pain and assessing the implementation of these interventions to improve pain management and reduce reliance on opioids. The NIH Collaboratory Coordinating Center serves as the PRISM Resource Coordinating Center.

December 8, 2021: NIH Collaboratory and IMPACT Collaboratory Offer Workshop on Dissemination and Implementation Research and Pragmatic Trials

Posted on by Damon Seils

Logo for AcademyHealthThe NIH Collaboratory is partnering with the IMPACT Collaboratory to offer a pre-conference workshop on December 13 at AcademyHealth’s 14th Annual Conference on the Science of Dissemination and Implementation in Health.

The workshop, Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials, will provide an introduction to investigative opportunities for pragmatic clinical trials embedded in healthcare systems, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy.

The workshop is being offered free to conference attendees but requires a separate registration. The workshop will provide strategies for integrating implementation research methods in the design and conduct of ePCTs. Speakers will share firsthand experiences and case studies from the NIH Collaboratory and the IMPACT Collaboratory.

The learning objectives of the workshop include:

  • To identify key areas of synergy between ePCTs and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing ePCTs within diverse healthcare systems, and to describe opportunities for integrating implementation research methods into ePCTs
  • To increase the capacity of health services researchers to address important clinical questions with ePCTs and implementation research methods

CONFERENCE DETAILS AND REGISTRATION
14th Annual Conference on the Science of Dissemination and Implementation in Health: Broadening Horizons for Impact: Incorporating Multisectoral Approaches into D&I Science
December 13, 2021

December 8, 2021: PCT Grand Rounds Asks, ‘Decentralized Trials: Naughty or Nice?’

Posted on by Damon Seils
Head shot of Dr. Adrian Hernandez
Dr. Adrian Hernandez

In this Friday’s PCT Grand Rounds session, Dr. Adrian Hernandez of Duke University will present “Decentralized Trials: Naughty or Nice?”

Dr. Hernandez is a professor of medicine at Duke University and a co–principal investigator of the NIH Collaboratory Coordinating Center.

The Grand Rounds session will be held on Friday, December 10, at 1:00 pm eastern. Join the online meeting.

December 1, 2021: PCT Grand Rounds to Highlight Primary Results of PPACT Study

Posted on by Damon Seils
Head shot of Dr. Lynn DeBar
Dr. Lynn DeBar, principal investigator of PPACT

In this Friday’s PCT Grand Rounds, the principal investigator of the PPACT study, an NIH Collaboratory Trial, will announce the study’s primary results.

Principal investigator Dr. Lynn DeBar of the Kaiser Permanente Washington Health Research Institute, will present “Primary Care-Based Behavioral Treatment for Long Term Opioid Users With Chronic Pain: Primary Results and Lessons Learned From the PPACT Pragmatic Trial.” The Grand Rounds session will be held on Friday, December 3, at 1:00 pm eastern.

PPACT, or the Collaborative Care for Chronic Pain in Primary Care study, was a pragmatic, cluster randomized trial that enrolled 850 patients who were receiving long-term opioid therapy for chronic pain. Patients in the intervention group participated in weekly group sessions that taught a variety of pain self-management techniques. The strategy was compared with usual care.

Join the online meeting.

PPACT was supported within the NIH Collaboratory by the NIH Common Fund and by cooperative agreements from the National Institute of Neurological Disorders and Stroke.

November 29, 2021: New Article From the NIH Collaboratory Examines Use of Incentives and Payments in Pragmatic Clinical Trials

Posted on by Damon Seils
Head shot of Dr. Andrew Garland
Dr. Andrew Garland

Members of the NIH Collaboratory’s Ethics and Regulatory Core examined the use of incentives and payments to patients included in pragmatic clinical trials. Their findings and preliminary recommendations are published in the December issue of Clinical Trials.

Incentives and payments to patients are used in both pragmatic trials and conventional explanatory trials. However, because pragmatic trials typically evaluate interventions in the context of “real-world” clinical settings, the use of incentives and payments can raise logistical, ethical, and regulatory challenges.

Dr. Andrew Garland, a postdoctoral fellow at the Johns Hopkins Berman Institute of Bioethics who works in the Ethics and Regulatory Core, and who is the lead author of the article, reviewed 9 NIH Collaboratory Trials that used incentives and other payments to patients. Garland and coauthors Dr. Kevin Weinfurt and Dr. Jeremy Sugarman used these examples to describe how the standard conceptual framework for ethical payments and incentives may not always be appropriate for pragmatic trials.

Read the full report.

This work was supported within the NIH Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. This work was also supported by the NIH through the NIH HEAL Initiative.

November 17, 2021: PCT Grand Rounds to Explore Digital and Mobile Health in Patient-Oriented Research

Posted on by Damon Seils
Headshot of Dr. Anish Agarwal
Dr. Anish Agarwal

In this Friday’s PCT Grand Rounds session, Dr. Anish Agarwal of the University of Pennsylvania will present “Exploring Approaches in Using Digital and Mobile Health in Patient-Oriented Research: Pearls and Pitfalls.”

Dr. Agarwal is an assistant professor of emergency medicine at Penn and the clinical innovation manager at the Penn Medicine Center for Health Care Innovation.

The Grand Rounds session will be held on Friday, November 19, at 1:00 pm eastern. Join the online meeting.