Pragmatic Clinical Trials: An Update on NIA-Funded Real-World Research to Improve Patient Care
Pragmatic clinical trials enable researchers to identify and test interventions in real-world situations and settings, such as hospitals, clinics, or physician practices. Because they connect with older adults where they already live and receive care, these types of clinical trials may reach more diverse older adult populations. In this blog post, Marcel Salive provides an update on NIA’s growing support for innovative pragmatic clinical trials on multiple aging-related topics.
Gerontological Society of America Inaugural
Barbara Berkman Award
The Gerontological Society of America announced on July 2nd 2021, that Susan Lane Hughes, PhD, Director of the UIC Center for Research on Health and Aging, Principal Investigator of the Midwest Roybal Center for Health Promotion and Translation, and designer of the Fit & Strong! program for persons with arthritis has been designated the inaugural winner of the Barbara Berkman Award for Excellence in interdisciplinary research with older adults. This new award that will be bestowed by the Social Research, Policy and Practice Section of the Society at its Annual Meeting on Friday November 12, 2021, in Phoenix AZ. The Award recognizes lifetime contributions to outstanding interdisciplinary research in aging. Under Dr. Hughes’ leadership the UIC Center for Research on Health and Aging has grown to encompass 35 faculty, representing 8 colleges and 18 departments across UIC. Her Roybal Center has been renewed by NIH consecutively for five continuous cycles and has provided more than $2.65 million in pilot funding to early-stage investigators from multiple disciplines who are now tenured faculty with distinguished careers in aging research. This investment has leveraged $128.8 million in research funding in aging at UIC. Finally, Dr. Hughes’ Fit & Strong! program was developed by an interdisciplinary team, has received numerous national awards, served more than 10,000 older adults, and is being provided in 32 states at present.
NIA COVID-19 Supplement Recipients
Principal Investigators: Sarah Berry, MD, MPH, Marcus Institute for Aging Research, Hebrew Senior Life; Vince Mor, PhD, Brown University School of Public Health
Drs. Berry and Mor were awarded a supplement to improve COVID-19 testing for underserved and vulnerable populations as part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program. This initiative will leverage the foundation of the IMPACT Collaboratory to establish IMPACT-COVID-19 (IMPACT-C), a collaborative dedicated to developing and evaluating SARS-CoV-2 testing strategies in highly vulnerable residents and health care workers of skilled nursing facilities. IMPACT-C will assemble the organizational, administrative, and expertise components necessary to swiftly conduct a rigorous vaccine trial, when available.
Principal Investigator: Ellen McCreedy, PhD, MPH, Brown University School of Public Health
Dr. McCreedy and her team will conduct a cluster randomized embedded pragmatic clinical trial (ePCT) by leveraging electronic health records of Bluestone Physician Services to test the effectiveness of a COVID-specific, advance care planning (ACP) intervention on documentation of care preferences among assisted living community (ALC) residents with AD/ADRD from 150 ALCs in 3 states.
Principal Investigator: Lewis Lipsitz, MD, Marcus Institute for Aging Research, Hebrew SeniorLife
Dr. Lipsitz and his team will evaluate the efficacy of a Massachusetts state-funded strategy to minimize the spread of COVID-19 among older adults and their care providers within Massachusetts NHs using multiple data sources. Efficacy will be measured over the 2-month intervention period among all residents in nursing homes (NHs) across Massachusetts compared to those in Connecticut, Rhode Island, New Hampshire, and Vermont.
Principal Investigator: Joshua Chodosh, MD, MSHS, NYU Langone Health
Dr. Chodosh and his team will design and pilot test an intervention that leverages the COVID-19 antibody and PCR status of residents and staff to inform staff-residents care assignments to minimize COVID-19 transmission rates. The team will conduct the study in two New York City facilities with high minority and AD/ADRD representation and compare intervention units using this strategy with those that do not.
Director of the Division of Biomedical Research Workforce
The NIH OD’s Office of Extramural Research is recruiting for the Director of the Division of Biomedical Research Workforce. This is an exciting opportunity to provide leadership on the program and policy aspects of research training and career development to support the NIH vision for the next generation of the biomedical research workforce. The position’s summary, qualification requirements, and application procedure are outlined here.
The application deadline is Nov 22, 2021.
Deputy Director, Office of Strategic Coordination/Common Fund
National Institutes of Health
The National Institutes for Health is looking for an experienced leader to plan, implement, and evaluate high impact programs that foster transformational discoveries and establish catalytic resources through the NIH Common Fund. This is an exciting opportunity to collaborate with senior leaders at the NIH and across the biomedical/behavioral research community to articulate cross-cutting research challenges, to identify emerging opportunities to overcome these barriers, and to implement bold and innovative programs.
As Deputy Director of the Office of Strategic Coordination (OSC), you will support all activities required to manage the NIH Common Fund, with emphasis on program planning and management. These programs are trans-NIH in nature and designed to have a broad and significant scientific and technological impact
on biomedical and behavioral research. You will establish collaborative relationships within the NIH, with other federal agencies, with the biomedical research community, and with the private sector. These relationships will inform your work as you provide executive and managerial leadership for CF programs.
Successful candidates will have broad scientific knowledge and extensive management experience. They will be familiar with NIH administrative processes and policies and will have demonstrated ability to work across organizational boundaries. Clinical and/or translational research experience is desirable, but
not required. Outstanding communication, teamwork and executive leadership skills are required. In addition, strong program management and relationship building skills are essential to the formulation of initiatives, resources, and policies that promote transformational research.
Please contact Hanh Ngo at email@example.com for questions about the application process, or Search Committee Chair, Dr. Carolyn Hutter, at firstname.lastname@example.org for questions about the position. Initial application rating and review cut-off is January 10, 2022; applications will be accepted until the position is filled.
Robert L. Kane Postdoctoral Fellowship
ROBERT L. KANE POSTDOCTORAL FELLOWSHIPS IN AGING, DEMENTIA, AND LONG-TERM CARE will nurture scholars with strong substantive expertise/interests in long-term care, healthcare systems and delivery, prevention and management of Alzheimer’s disease and related dementias (ADRDs), intervention design/ development, systems innovation, health equity, and/or quality of care/quality of life among older adults and their family/professional caregivers. Methodological skills in one or more of the following areas are preferred:
(1) intervention research;
(2) quantitative/longitudinal methods;
(3) qualitative or mixed-methods;
(4) community-engaged research methodologies;
(5) program or policy evaluation; and/or
(6) implementation and dissemination
Please email applications or direct further queries to: Ashley Millenbah, MPH, Robert L. Kane Endowed Chair Coordinator, email: email@example.com; phone: 612-424-1894
Health Scientist Administrator - Clinical Applications and Prevention Branch
A Health Scientist Administrator position is available within the Clinical Applications and Prevention Branch. The branch is seeking outstanding candidates with scientific expertise in one or more of the following areas: promotion of cardiovascular health and prevention of cardiovascular disease using a wide range of intervention approaches and reduction in health disparities; expertise in the behavioral, biological and social determinants of health; randomized trials including novel clinical trial designs, and pragmatic trials; and intervention research using clinical data science to inform and conduct clinical trials.
For more information and to apply, visit USAJobs by visiting the below links to access the NIH global recruitment for Health Scientist Administrators, open September 20th through September 29, 2021.
Webinars & Workshops
Conducting Intervention Development and Intervention Research in Palliative Care
Wednesday, December 1, 2021 | 1:00 PM – 2:30 PM EST
Describe aspects of developing successful interventions for research in vulnerable populations with serious illness
Identify aspects of subject criteria and intervention development that will influence research outcomes
Recognize special considerations in recruiting and supporting research subjects from underserved communities
"Advances in Lung Cancer Supportive Care: What We Know and Where We’re Headed"
Tuesday, November 30, 2021 | 2:00 PM – 3:00 PM EST
To present current research, clinical perspectives and lived experiences of supportive care in lung cancer
To describe lessons learned in the provision of lung cancer and supportive care and what is needed in the future
To examine the expansion of lung cancer supportive care services across the lifespan with a health equity focus
RCCN Workshop Travel Awards for Early Career Investigators
“Measuring Biologic Age”
January 19-20, 2022 | Bethesda, Maryland
The goal of the NIA’s Research Centers Collaborative Network (RCCN)is to bring together researchers from the 6 NIA Centers programs to foster the development of cross-center collaborations around issues important to the health and well-being of older adults. The RCCN is sponsoring a workshop series to address problems of high relevance to multiple NIA Center programs. These workshops will feature the sharing of paradigms, conceptual models, and key insights from perspectives of the participating centers programs. The sixth workshop, “Measuring Biologic Age”, will be held January 19and 22, 2022in Bethesda, Maryland. The scope of the workshop is broad and includes these themes: conceptual issues relevant to defining biologic age, whether what can be measured is useful, how to choose a measure of biologic age, and what are the potential applications and implications? The format of the workshop will include a series of brief talks (think TED talks) providing high level conceptual introductions of key aspects as they relate to measuring biologic age. Presentations will be followed by moderated discussions. The meetings will have a dedicated sessions discussing areas that would be most promising for inter-center collaboration. An RFA for trans-disciplinary pilots will be issued following each workshop available to investigative teams with researchers from two or more different center programs to address promising areas arising from the workshop proceedings.
Travel Awards are available for approximately10 early career investigators or investigators in-training, who will participate in a special session at the meeting on January 19, that will focus on career development. The travel awards will cover travel to and from the meeting, meals, and hotel accommodations. Successful applicants will be from institutions with at least one NIA supported center, and who have demonstrated translational or multidisciplinary interests in aging related to the workshop topic. Individuals from underrepresented racial and ethnic groups are particularly encouraged to apply. For applicants who are not selected for this award but are still interested in attending the meeting, limited space may be available.
Building Skills to Conduct Embedded Pragmatic Clinical Trials for People Living with Dementia and their Care Partners
Wednesday, January 26th, 2022 | 11:00am - 3:00pm ET
Thursday, January 27th, 2022 | 10:00am - 4:00pm ET
| Application closes October 22 |
This virtual 1.5-day workshop will provide a foundation in practical aspects of designing and conducting ePCTs in Alzheimer’s disease and related dementias (AD/ADRD) through a combination of activities including: panel discussions, small group sessions, and networking opportunities with experts in the field. Participants will gain knowledge in ePCT design and method, problem-solve challenges faced in current or planned projects, and network and engage with the larger community of IMPACT investigators. Throughout the program, special attention will be paid to key considerations in integrating health equity and addressing ethical challenges in the design of ePCTs for these populations to ensure health equity.
This year’s modules will focus on:
Integrating health equity into the design of ePCTs
Common ethical and regulatory challenges with conducting ePCTs in people living with dementia and care partners
Opportunities and challenges in conducting ePCTs with care partners of people living with dementia
The presentation recordings and slides are now available from the RCCN Virtual Workshop Inclusion of Older Adults in Clinical Research!
The meeting included sessions on aspects of including older adults in clinical research including the Current Situation, Barriers - Real and Perceived, Making the Case, and Best Practices for Reaching Out to Colleagues
Selected presentation recordings from the workshop:
Emory Roybal Center for Dementia Caregiving Mastery Pilot Project Funding Announcement
The Emory Roybal Center for Dementia Caregiving Mastery is specifically focused on the development of interventions to improve and support dementia caregiving mastery
Informal caregiving is the key to the quality of life and
continued community living of persons living with Alzheimer’s
disease and similar illnesses
Providing masterful care enhances care recipient and caregiver
Pilot Project Award Program
Supports both junior and senior investigators across the U.S. to conduct NIH Stage I-III intervention research that will strengthen the context-specific role mastery of informal caregivers of persons living with a dementing illness
Provides mentoring and Design Studio support to strengthen pilot applications
Provides pilot awards in amounts of $75,000-115,000 for 12-months (total direct and indirect).
LOI due: December 03, 2021
Application invitations; mid December, 2021
NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurship Enhancement Award (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.
To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
Courses for Skills Development
Curriculum or Methods Development
The purpose of the Research and Entrepreneurial Development Immersion (REDI): NIA Entrepreneurship Enhancement Award (R25) is to promote the development of entrepreneurial education programs that are designed to broaden the skillset of graduate students and postdocs, as well as early career master's, Ph.D., and Dr.P.H. scientists, in fields relevant to the mission of NIA, including aging and Alzheimer's disease (AD) research. The goal of this program is to prepare trainees for a wide range of career paths, including those that are outside the normal research environment.
NIA Research and Entrepreneurial Development Immersion (REDI): Mentored Entrepreneurial Career Development Award (K01 Clinical Trial Not Allowed)
The purpose of the NIA Research and Entrepreneurial Development Immersion (REDI): Mentored Entrepreneurial Career Development Award is to provide support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. This specific K01 Funding Opportunity Announcement (FOA) includes entrepreneurial training and career development opportunities for early-career academic scientists as part of its translational research and supervised career development activities. This program will provide support and protected time for a broad set of supervised career development activities to prepare awardees for a multitude of career options including research and teaching faculty, as well as entrepreneurial, industry, science policy, and research administration positions. Entrepreneurship training and the research activities proposed would both be considered major components of the award. NIA invites K01 applications from experienced postdoctoral (two years minimum) and/or recently appointed junior faculty (usually with a Ph.D. degree) in biomedical, social, or behavioral sciences who are interested in entrepreneurial training and are pursuing careers in research areas supported by NIA.
This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this FOA, candidates are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.
New York Regional Center for Diabetes Translation Research Pilot and Feasibility Program Funding Announcement
The New York Regional Center for Diabetes Translation Research (NY-CDTR) announces the availability of Pilot and Feasibility (P&F) funding for preliminary studies to support planned extramural funding applications (NIH preferred) for diabetes-related translational research. Secondary analyses of existing, pertinent large data sets, which can lead to external funding, are a priority.
Budget requests can be up to $50,000/year for one-year grant proposals, or up to $25,000/year for 2 years.
For 2021-2022, meritorious proposals for $50,000/year for 2 years will also be considered, with a maximum of one award being granted. A 2nd year of funding is always contingent on progress and available program funding.
Proposals should use translational research methods such as: implementation or dissemination science, natural experiment methods, as well as quantitative or qualitative methods to investigate how to improve diabetes prevention or care and outcomes at the individual, group, health system or population level.
Applications involving research in diabetes/obesity across the life span, population health, health systems, or natural experiments are strongly encouraged. Translation research focused on Latinos/Hispanics, health disparities, and social determinants of health is of particular interest. P&F funds may supplement ongoing funded research projects (e.g., K awards), but non-overlap must be clearly demonstrated in the proposal. The NY-CDTR website (www.nycdtr.org) provides information re: core resources and services available to awardees to support their pilot study.
Must hold the rank of Assistant Professor (or equivalent) or higher at the time of the award.
This program is designed to support (in order of priority):
1) New investigators, early stage investigators (ESIs), and under-represented minority investigators (URMiR) with interests in diabetes and/or obesity. In this category are investigators shifting from mentor-based research to an independent career. Meritorious proposals from these investigators receive the highest priority for funding.
2) Established investigators, in other research areas or cross-disciplinary research, who wish to apply their expertise to diabetes or obesity. High-risk, high-reward proposals receive priority.
3) NY-CDTR members who wish to explore a new area of innovative research that constitutes a substantive departure from their previous or ongoing externally funded diabetes research.
Two Supplement Awards to IMPACT Collaboratory Will Link Big Data and the Impact of COVID-19 on People Living with Dementia
The NIA IMPACT Collaboratory has been awarded two COVID-19 Supplements partnering with major retail pharmacies to create a massive monitoring system of the long-term safety and efficacy of COVID-19 vaccination on people with AD/ADRD.
These two studies are:
Monitoring Medicare Beneficiaries' Response to COVID vaccines (CVS Project)
This project established an active post-vaccination surveillance system of a large population to track and report safety and outcomes related to SARS-CoV-2 vaccine(s). Working jointly with CVS Health and the Medicare & Medicaid Resource Information Center (MedRIC) at Acumen, LLC, the project established a data infrastructure to monitor the effects of COVID-19 vaccines administered to Medicare beneficiaries by CVS across the country. Data transfers from the national retail pharmacy chain are merged with Medicare data. The resulting data base is analyzed to identify demographic, race/ethnicity, clinical (e.g., ADRD), and health care system factors associated with being vaccinated, estimate the rate of adverse events attributable to the vaccine and estimate breakthrough COVID illness among vaccinated Medicare beneficiaries. This program provides the basis for assessing mid- to long-term safety and efficacy of the different vaccines being distributed for use in the elderly population in the country.
Medicare Match for post-vaccination monitoring (Walgreens)
This project builds on the researchers’ partnership with CVS to establish a data infrastructure to monitor the effects of COVID-19 vaccines administered to Medicare beneficiaries by CVS across the country. The goal of this project is to add data from Walgreen’s 13,231,175 million Medicare beneficiary pharmacy customers to the existing infrastructure which will increase the research team’s capacity to track immediate and long term effects of vaccination on nearly half the population of Medicare beneficiaries.
The need for a larger study population is particularly important because those with ADRD already suffering from neurodegenerative diseases may be at greater risk of serious neurological adverse events of vaccines. In addition, the unknown potential for adverse events may result in high rates of incomplete vaccination (both shots) among older adults. Such uncertainty contributes to vaccine hesitancy and may result in large disparities in SARS-CoV-2 vaccination among racial/ethnic groups, for which disparities in seasonal influenza vaccination already exist.
To learn more about these studies, visit this page on Building Infrastructure Supplement Awards, and the press release from Brown University at this link.
Notice of Intent (NOI) to Publish a New Funding Opportunity Announcement for Upcoming IMPACT Pilot Grants
RFA Release | August 16, 2021
Letter of Intent due | September 17, 2021
IMPACT funds several one-year awards of pilot pragmatic clinical trials (ePCTs) that test non-pharmacological interventions embedded in health care system(s) for people living with Alzheimer’s Disease (AD) and AD-related dementias (ADRD) and their care partners. Under this mechanism, interventions must be linked to the needs of a health care system. More information on the IMPACT Pilot Grants Program can be found here.
The goal of the pilot projects is to generate the preliminary data necessary to design and conduct a future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model). The IMPACT Collaboratory will give preference to applications that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity. It is anticipated that Pilot Projects will be funded for up to $175,000 in direct costs for a maximum of 12-months.
Stay tuned for updates regarding the release of the RFA, an informational webinar and application deadline. If you have questions related to this funding opportunity, please contact IMPACTcollaboratory@hsl.harvard.edu. The IMPACT Collaboratory will share additional details as they become available on the website at www.IMPACTcollaboratory.org.