Call for Clinical Trial Proposals

The NBER Roybal Center for Behavior Change in Health seeks proposals for research projects that involve randomized controlled trials (RCTs) or other NIH-defined clinical trials, and that, if approved for funding by the National Institute on Aging (NIA), would receive support during the period June 1, 2025 through May 31, 2026. Eligible projects must explore some aspect of the relationship between health and human behavior and must be adequately powered to detect meaningful treatment effects. Potential project funding is likely to fall in the range of $175,000 to $260,000 of direct costs.

Is your project an NIH-defined clinical trial? The answers to the following four questions must be “yes”:

1. Does the study involve human participants?

2. Are the participants prospectively assigned to an intervention?

3. Is the study designed to evaluate the effect of the intervention on the participants?

4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

   
   

Proposals will be evaluated by the Center co-PIs (Marcella Alsan and Joseph Doyle) and Advisory Committee for research design, relevance, feasibility, scalability, and timeliness. We look for projects that propose to test scalable interventions with the potential to broadly improve population health as people and prioritize those with the potential to advance through the NIH Stage Model for Behavioral Intervention Development. Projects that evaluate mechanisms of behavior change are of particular interest.

To be eligible for support, subject recruitment for the study may not have started yet, and it must be possible to delay recruitment until after formal NIH approval.  The project must comply with all NIH clinical trial policies.

We welcome proposals from affiliates and non-affiliates, junior researchers, and scholars who are members of groups that are under-represented in the economics profession.

Please direct questions to the Associate Director of the NBER Roybal Center, Sarah Holmes Berk (sholmes@nber.org, 617-588-1445). 

Next steps / How to apply: 

• This summer/fall:  Reach out to us about potential project ideas and determine suitability for an application.

• By Monday, January 6, 2025: Submit a brief description of your project (including power calculations) and anticipated budget needs. Upload a PDF with this information here.

• By Friday, January 24, 2025: We will tell you if we are able to include your project.

• By Monday, February 24, 2025: Using templates and instructions we will provide, submit your Specific Aims, 2-page Research Design, Human Subjects Questionnaire, Planned Inclusion Enrollment Report(s), Budget, Biosketch, and Other Support.

• During March 2025: Review and approve your Human Subjects System record, which we will draft. Complete applicable NBER and NIH administrative requirements.

• Summer 2025: We will learn if your study has been approved by the NIH. Depending on the risks associated with your study, the NIH may require your study to receive Data & Safety Monitoring Board (DSMB) and/or Safety Officer (SO) approval before recruitment can begin.

• For as long as your study continues: Update us periodically on your progress. If applicable, update the DSMB and/or SO periodically and submit monthly enrollment data to NIA. Help us maintain your ClinicalTrials.gov and Human Subjects System records.

• The University of Illinois Chicago (UIC) Midwest Roybal Center for Health Promotion and Translation seeks to advance the science, translation, and practice of health promotion programs for underserved older adults at risk of Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) in order to improve the functioning and quality of life of this growing segment of our population.

Click here to see full funding announcement

Funding Opportunity: Interventions Preventing or Delaying Cognitive Decline and AD/ADRD

The Midwest Roybal Center is holding a competition that will review and award up to 2 randomized controlled trials. Trials will begin June 1, 2025. Projects can be funded for up to $200K direct total for 1 or 2 years.

LOI:  December 9, 2025

Final proposal due (if selected):  January 20, 2025

The University of Illinois Chicago (UIC) Midwest Roybal Center for Health Promotion and Translation seeks to advance the science, translation, and practice of health promotion programs for underserved older adults at risk of Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) in order to improve the functioning and quality of life of this growing segment of our population.

Application Details:

The Midwest Roybal Center will award applications that successfully:

• Include interventions that prevent or delay cognitive decline and AD/ADRD that:

  • Target mechanisms of behavior change to promote behavioral and lifestyle change in individuals or groups at risk of cognitive decline and AD/ADRD AND/OR

  • Spur the initiation and maintenance of physical activity regimens to prevent or delay cognitive decline and/or AD/ADRD that are personalized to individuals or groups who share specific characteristics and/or preferences AND/OR

  • Leverage technology to prevent or delay cognitive decline and/or AD/ADRD

• Have a primary focus on behavioral and/or social intervention development.

• Focus on mid-life and older individuals.

• Have goals to improve the health and well-being of people living with dementia (PLWD), or with a focus on behavioral and/or social interventions to prevent or delay cognitive decline and/or AD/ADRD.

• Specify, within their Specific Aims, the Stage of research, as defined by the NIH Stage Model, for the clinical trial proposed.

• State and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for the clinical trial proposed.

• Have the goal of serving as inclusive a population as possible, and applicants are required to describe how they will recruit participants from minority health and health disparity populations.

• Address issues of statistical power for proposed clinical trials. All clinical trials must have adequate statistical power to test mechanisms of behavior change and/or efficacy of the intervention. This includes Stage I “pilot” testing studies that include a specific aim to test the efficacy of an intervention, or the mechanism of behavior change of an intervention.

  
  

Awardees are expected to participate in Midwest Roybal Center activities pertaining to research, education, and service and will be expected to make brief presentations to the Center Executive and Advisory Committees during the course of the RCT and upon its completion. Awardees must comply with NIH and NIA reporting requirements e.g., ClincalTrials.gov and CROMS. Funded RCTs may also be required to participate in an NIH data sharing plan and in a Center Data Safety Monitoring Committee.

Eligibility:

Open to all US research and clinical faculty.

Submit LOI here (users will need to create an InfoReady account).

Questions? Email Andrew DeMott, ademot1@uic.edu

Click here to see full funding announcement

UIC Midwest Roybal Center Info Sheet.pdf

Download PDF • 1.96MB

Behavioral Intervention Development Funding Opportunity

The Translational Research Institute on Pain in Later Life (TRIPLL) announces a behavioral intervention development grant program, designed to support social and behavioral clinical trials that will test non-pharmacological pain and pain management interventions in later life. TRIPLL will award up to $210,000 direct costs per year for up to 2 years.

Final proposal due (if selected):  January 15, 2025

Earliest start date, pending NIA review:  July 1, 2025

TRIPLL sponsors clinical trials that apply the NIH Stage Model for Behavioral Intervention Development. TRIPLL is particularly interested in receiving applications to support Stage II-III clinical trials that engage participants from medically underserved, racially and ethnically diverse older adults. We will also consider applications of Stage 1b or Stage IV trials and hybrid pragmatic trials. TRIPLL will also consider applications requesting supplemental funding for already funded clinical trials that seek to increase sample size, add pain outcomes, or add new sites or populations of older adults.

TRIPLL is funded by a 5-year grant from the National Institute on Aging (National Institutes of Health).

Projects that could be funded by TRIPLL include, but are not limited to:

• A Stage II efficacy trial of a mobile health application to increase patient positive affect as a means to mitigate the impact of pain

• A Stage III multi-site effectiveness trial of a program that encourages physical activity, testing behavioral mechanisms such as increased self-efficacy for pain management

• A Stage III multi-site effectiveness trial that provides novel psychological therapy to shift beliefs about the causes of pain.

• A Stage II or III intervention directed at health care providers to increase referral of patients to non-pharmacological treatments and therapies to help manage pain.

• Stage IV testing of a public health/raising awareness intervention designed to increase physical activity among older office workers

• Conducting a pragmatic effectiveness–implementation hybrid trial of low-cost pain medication management strategies through Visiting Nuse Services

To compete successfully for funding, applicants must propose clinical trials based on the NIH Stage Model for Behavioral Intervention Development, focus on mechanisms of behavioral change, and demonstrate potential for future funding and implementation. TRIPLL welcomes projects that partner with community agencies serving older adults.

PhD and MD level Investigators from all US institutions are eligible to apply. Multidisciplinary teams are highly encouraged.

Letter of intent (LOI)

A letter of intent to apply for funding is required. The letter of intent is due December 1, 2024. Letters of intent will be reviewed and ranked by TRIPLL investigators and advisory board members. TRIPLL will extend invitations for the submission of pre-proposals that will be due January 15, 2025.

The letter of intent should be 1-2 pages in length. Please describe the trial to be conducted and the evidence upon which the proposed trial is based. Letters of intent should state: 1) NIH Stage of the trial (or type of hybrid effectiveness); and 2) Behavioral mechanism of change targeted in the trial. The letter of intent should be accompanied by current NIH standard biosketches for all study investigators.

Application Process

To be considered for funding, investigators must submit a 6-page proposal by January 15, 2025, to Patricia Kim at pak2020@med.cornell.edu. TRIPLL’s Review Panel will meet in January 2025 to review/rank the final proposals and select the most meritorious applications.

The 6-page pre-proposal (single-spaced) should include: 1) Significance and Background; 2) Innovation; 3) Research Approach (the Approach must include a power analysis); 4) If applicable, information on the collaborating agency/ies and how the collaborative process will take place; and finally; 5) Description of any current funding and timetable for applying for additional funding after the trial is completed. If the project includes collaboration with a community agency, the application must be accompanied by a signed letter of agreement from the director of the agency. A one-page Specific Aims must also be included, as well as references (but are not counted in the 6 page limit). As appendices, applicants must include current NIH biosketches for project investigators and a letter of commitment from the agency partner (if applicable). Partnering agencies must have 501(c)3 status.

Allowable expenses include research-related costs, research assistant salaries with fringe benefits, communications and supplies, respondent incentives, travel related to the research, data and resource sharing expenses, and equipment purchases less than $1500. Salary support for the Principal Investigator is permitted but must be thoroughly justified how such salary support is critical to performing the proposed research tasks. Additionally, if the investigator plans to work with a community agency (or agencies), it is generally expected that a fund for the collaborating agencies will be provided to cover expenses they may incur.

How will projects be selected for funding?

The TRIPLL review panel will evaluate grant proposals, respectively. Funding decisions will be announced on February 15, 2025. Reviewers will evaluate projects based on the timeliness of the proposed project, immediate relevance, and application to developing feasible non-pharmacological interventions appropriate for older people with chronic pain, scientific merit, the feasibility of completion in the time requested, probability of attracting outside funding, and qualifications and commitment of the investigator to the project. Proposal reviewers will examine an applicant’s record of scholarly productivity and proposal submission activity when making funding decisions.

If you are awarded a TRIPLL grant:

1. Your project will be reviewed by the National Institute on Aging before funding is released. 

2. By March 15, 2025 you must complete a checklist of items required for the NIA review. Behavioral Intervention Core Director Elaine Wethington (ew20@cornell.edu) will provide you with a copy of the checklist for submission to TRIPLL. Instructions are included with the checklist. TRIPLL must submit the completed checklist to NIA no later than April 1, 2025. This deadline is firm and cannot be extended.

3. Study investigators are expected to make two presentations about study progress to the TRIPLL Executive Committee during the year, and investigators must meet at least quarterly with the TRIPLL investigators to report on the project’s progress.

4. Investigators may be asked to present their projects and project findings at online meetings convened by the Roybal Centers Coordinating Center.

Questions? Email TRIPLL’s Program Manager, Patty Kim at pak2020@med.cornell.edu

Click here to see full funding announcement