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

Notice of Funding Opportunity: Behavioral Intervention Trials

The Brigham and Women's Hospital Roybal Center for Therapeutic Optimization Using Behavioral Science (funded through NIA RFA-AG-24-006) seeks to develop and test principle-driven, potent, practical, scalable, and sustainable behavioral interventions to enhance the appropriate prescribing of and adherence to evidence-based medications with the goal of improving the lives of midlife and older people. We are pleased to issue a call for proposals for randomized clinical trials that test behavioral interventions aimed at improving evidence-based medication use. These trials should measure clinically-relevant outcomes and should aim to generate strong preliminary data for follow-on funding. For the upcoming year, we will support 2- 3 projects with a maximum annual direct cost of $200,000. Most projects will be funded for a 12-month period, starting June 1, 2025 (pending NIA approval), although projects of up to 24-months will also be considered.

Eligibility

Eligible investigators include, but are not limited to, Early Stage Investigators (ESIs) and established investigators from academic, non-profit or corporate institutions. Applicants who are underrepresented minorities and applicants who have not previously received funding through the BWH Roybal Center for Therapeutic Optimization Using Behavioral Science are particularly encouraged to apply. Eligibility for investigators outside of the US is based on NIH policies listed in the NIA Roybal RFA and as further detailed in the NIH Grants Policy Statement. Collaboration with individuals who have experience successfully conducting pragmatic clinical trials of behavioral interventions, including with Center affiliated faculty, is strongly recommended for all applications.

Evaluation Criteria

Applications will be evaluated using criteria: (1) the significance of the medication use problem being addressed including its potential to promote healthy aging; (2) the strength and novelty of the principle-driven behavioral intervention being evaluated including the rigor of supporting preliminary data; (3) the scientific approach including the appropriateness of the study outcomes, how mechanisms of actions will be evaluated and whether novel analytic methods and technological approaches are used to gain a deeper understanding of mechanisms of behavior and to facilitate the creation of interventions that are personalized but applicable to population health improvement; (4) the feasibility that the study can be carried out; (5) the quality, diversity and complementarity of the investigative team, including experience in conducting trials; and (6) the potential to lead to follow-on funding, such as an R01. Examples of successfully funded projects can be found here.

Application Process

For the first phase of the trial review process, please submit a, letter of intent (LOI) containing:

1. General Information

a) Descriptive title of proposed activity

b) Name(s), address(es), and telephone number(s) of the PI(s)

c) Names of other key personnel and participating institution(s)

d) Estimated budget (total direct and indirect) 2 Center for Healthcare Delivery Sciences │1620 Tremont Street, Boston, Ma 02120

2. Research Strategy (maximum 2-pages, single-spaced pages with one-inch margins) containing the following information:

a) Description and significance of the medication-use problem being addressed

b) Proposed behavioral intervention, its theoretical underpinnings and hypothesized mechanism of behavior change for the problem being

c) Brief description of research design including study design, subject eligibility criteria, intervention description, primary outcomes and method to evaluate mechanism of behavior change

d) Proposed study setting and timelines

e) Summary of qualifications of the investigative team

3. NIH Biosketch:

An NIH format biographical sketch must be submitted for the PI(s) and all Co-Is. Please follow this link for biosketch instructions and samples.

We would be pleased to meet with prospective applicants interested in discussing proposal ideas. Please email us at c4hds@bwh.harvard.edu to request a consultation. The LOI should submitted via email to c4hds@bwh.harvard.edu by November 1, 2024, 5pm ET. Highly-ranked LOIs will be notified that they have been invited to submit a full application by the first week of December 2024. Full application will be due January 6, 2025. Prior to this date, those invited to the full proposal stage will be required to meet with the BWH Roybal Center Behavioral Intervention Development (BID) Core to discuss their study design and plans for the conduct of the proposed trials

Awarded pilot projects are anticipated to begin June 1, 2025, pending NIA approval.