December 8, 2020: PCORI to Issue Funding Announcement for Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes

The Patient-Centered Outcomes Research Institute (PCORI) will issue a funding announcement in January for pragmatic clinical studies to evaluate patient-centered outcomes. A total of $90 million will be available in the funding cycle to support individual awards of up to $10 million in direct costs with a maximum project duration of 5 years.

More from the preannouncement:

PCORI seeks to fund clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare system-level approaches to managing care; or eliminating health or healthcare disparities. Randomized study designs are strongly encouraged but not required.

Proposed studies must address critical clinical choices faced by patients, their caregivers, clinicians, or delivery systems. They must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups.

The PCORI funding announcement will open on Tuesday, January 5, 2021, with more information about the funding opportunity.

October 20, 2020: All of Us Research Program Issues Funding Opportunity for New Engagement Partners

The All of Us Research Program has issued a new funding opportunity seeking partnerships with national, state, and local engagement partners to recruit and engage participants in the landmark NIH program. Through these partnerships, All of Us aims to create bidirectional and co-equal relationships that engage communities that have historically been underrepresented in biomedical research.

Logo for the All of Us Research Program

All of Us, a historic effort to accelerate research and improve health, launched nationally in 2018 to create one of the most comprehensive and diverse biomedical data resources of its kind. More than 358,000 participants have enrolled in the program. This latest funding opportunity illustrates the program’s commitment to partnering with organizations that are influential in their respective communities, especially those organizations that work with diverse communities.

The program anticipates funding at least 6 awards in fiscal year 2021 through this latest funding opportunity, each with a total project period of 5 years. Applications are due on November 23, 2020.

All of Us encourages eligible applicants with experience working with and engaging underrepresented communities to apply for this funding. All of Us considers the following populations underrepresented in research: racial and ethnic minority groups; children and seniors; sexual and gender minorities; people living with disabilities; people with barriers in access to care; people who have low income or low educational attainment; and rural residents.

For full details regarding this opportunity, please see the funding announcement.

April 29, 2020: New ePCT Funding Opportunities Available From the NIA IMPACT Collaboratory

The NIA IMPACT Collaboratory has announced 2 new funding opportunities to support embedded pragmatic clinical trials (ePCTs) of nonpharmacological interventions within healthcare systems to improve the care of people living with Alzheimer disease and related dementias and their care partners. Applications that address dementia care for people of all backgrounds and that promote health equity are a high priority.

  • Career Development Awards: The NIA IMPACT Collaboratory funds 2 to 3 career development awards annually. These awards support the development of early-stage investigators who seek careers conducting ePCTs. Optional informational webinars on April 29 and May 20 will provide prospective applicants with an overview of application details. The webinars will be recorded and posted online. Read the full funding opportunity description.
  • Pilot Studies: The NIA IMPACT Collaboratory funds several 1-year pilot studies annually to support the generation of preliminary data necessary to design and conduct a full-scale ePCTs. In response to the COVID-19 public health emergency, this cycle of awards will prioritize applications that propose pilot ePCTs of telemedicine, telehealth, and remote technologies interventions. An optional informational webinar on May 6 will provide prospective applicants with an overview of application details. Read the full funding opportunity description.

The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.

April 27, 2020: NIH Announces Supplemental Funding Opportunity for Research on Stigma in Pain Management, Opioid Use, and Opioid Use Disorder

The NIH Office of Behavioral and Social Sciences Research, with other NIH Institutes, Centers, and Offices, has issued a notice of special interest calling for research on stigma in the context of chronic pain management and opioid use or opioid use disorder. The NIH will support administrative supplements to current awards and cooperative agreements under the Helping to End Addiction Long Term (HEAL) Initiative. A total of up to $3.5 million is available for the supplemental awards. Applications will be accepted through May 29, 2020.

This funding opportunity will give high priority to projects that analyze strategies to reduce stigma, discrimination, and prejudice related to chronic pain management and/or opioid use disorder; and to projects that use existing psychometrically validated tools to measure stigma (or that support the development of new measurement tools, if there is compelling rationale). Specific areas of interest include:

  • The impact of internalized and anticipated stigma on prevention, management, treatment, and recovery.
  • Prejudice by care providers that undermine treatment and health-related quality of life.
  • Strategies to address stigma among healthcare providers, workplace colleagues, emergency responders, family and friends, and others.
  • Strategies to address internalized stigma.
  • The adaption and application of existing theories of health-related stigma to chronic pain and/or opioid use disorder in reducing stigma.
  • Analyses of combinations of approaches that are known to reduce discrimination and prejudice.
  • Approaches to build resilience to discrimination and prejudice.
  • First-stage development of multicomponent approaches that could be expanded and implemented for large-scale multicomponent research projects.

Application and submission information is available in the full notice of special interest.

February 4, 2020: NIH Videocast Will Offer Pre-Application Assistance for PRISM Funding Opportunity

The National Center for Complementary and Integrative Health (NCCIH) will hold an NIH Videocast on the recently reissued RFA-AT-20-004, “HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) (UG3/UH3, Clinical Trials Optional).” The videocast, to be held on Monday, March 2, from 2:30 to 3:30 pm eastern, will provide an overview of the funding opportunity and address questions from potential applicants. The webinar is optional and not required for application submission.

The NCCIH, with other NIH Institutes, Centers, and Offices, reissued the funding opportunity announcement on January 23 to solicit applications for the PRISM program. The PRISM funding opportunity will prioritize pragmatic trials embedded in healthcare systems, with focus in the following areas:

  • pain management in emergency departments, dental clinics, primary care, and hospitals
  • chronic overlapping pain conditions
  • pain management in individuals at risk of or with opioid use disorder
  • pain management in those with co-occurring mental health disorders
  • noncancer pain management in persons with medical comorbid conditions

PRISM is part of the HEAL Initiative, which was created in April 2018 to speed scientific solutions for addressing the national opioid crisis.

January 7, 2020: NCCIH to Reissue PRISM Funding Opportunity and Host Pre-Application Webinar

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, will reissue a funding opportunity announcement to solicit applications for the HEAL Initiative’s Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program. The NCCIH published its notice of intent to reissue the PRISM announcement to allow potential applicants time to develop proposals responsive to the funding opportunity. The reissuance is expected by January 30.

The NCCIH will host a pre-application webinar on March 2 to provide an overview of the PRISM funding opportunity and to address questions from potential applicants. The webinar is optional and not required for application submission.

The PRISM funding opportunity will prioritize pragmatic trials embedded in healthcare systems, with focus in the following areas:

  • pain management in emergency departments, dental clinics, primary care, and hospitals
  • chronic overlapping pain conditions
  • pain management in individuals at risk of or with opioid use disorder
  • pain management in those with co-occurring mental health disorders
  • noncancer pain management in persons with medical comorbid conditions

PRISM is part of the HEAL Initiative, which was created in April 2018 to speed scientific solutions for addressing the national opioid crisis.

May 14, 2019: NIH Announces 3 New Funding Opportunities in Dissemination and Implementation of Evidence-Based Interventions

The NIH published 3 new funding opportunity announcements to support innovative approaches to the implementation of evidence-based interventions and the de-implementation of ineffective interventions. The announcement also encourages studies that advance dissemination and implementation research methods. The 3 funding opportunities are as follows:

 

February 13, 2019: Proposals Due for Pragmatic Trials of Acupuncture Treatment in Older Adults With Chronic Low Back Pain

Proposals are due March 15 in response to an NIH funding opportunity announcement for embedded pragmatic clinical trials that address pain management and the opioid crisis. The NIH will support 1 to 2 pragmatic trials that evaluate acupuncture treatment in older adults with chronic low back pain. The projects will join the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research.

Read the full announcement: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults

The request for applications is 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.

December 13, 2018: New Living Textbook Chapter: Developing a Compelling Grant Application

A new chapter in the Living Textbook provides expert advice for investigators submitting an application for a pragmatic clinical trial to the NIH. The chapter covers finding the right Program Official and opportunity announcement, writing a strong proposal, addressing review criteria, and award status.

“First and foremost, develop and clearly define a clinical research question with a testable hypothesis and then select an experimental design best suited to answering the research question. The study question drives the research design.” —From Developing a Compelling Grant Application

Dr. Wendy Weber, the Program Officer for the NIH Collaboratory Coordinating Center, and Dr. Marcel Salive, a Program Officer from the National Institute on Aging, contributed to this chapter.

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.