Digital Health Technologies Research Grants

In October 2022, the Food and Drug Administration (FDA) released Spotlight: Digital Health Regulatory Science Research Opportunities, which outlines important research areas identified by stakeholders seeking to advance the digital health landscape. “Digital health offers the potential to reach many underserved communities and improve the health care individuals receive. Stakeholders across the digital health ecosystem should approach development, implementation, and advancement of digital health solutions thoughtfully to promote health equity and user trust in new technologies,” the report states. The report also notes that the increased use of evidence-based DHTs has “the potential to support more equitable access to health care, improve patient outcomes, and promote public health.”

To help focus these research efforts, the PhRMA Foundation seeks to fund research aimed at answering FDA’s questions regarding the use of DHTs for regulatory decision-making for populations typically underrepresented in research.

The program aims to support research that will:

• Develop, evaluate, and/or implement DHTs for use in clinical trials in diverse populations to improve participation.
• Assess use cases where DHTs are appropriate and where they may disadvantage a particular population.
• Demonstrate verification, validation, and/or qualification of DHTs to measure and/or capture data across diverse populations.

Research topics, including but not limited to those listed below (as outlined in the FDA’s Spotlight), must be examined through an equity lens:

• Consumer-grade DHT verification and validation in specific clinical and regulatory applications
• Novel digital biomarker validation in relevant contexts of use
• Platform usability requirements for patients
• Data characteristics/requirements to be used in clinical, regulatory, and other decision-making
• Standardization of patient-generated health data from different sources
• Data synchronization and interoperability of multiple sources of patient-generated health data
• Performance specifications for use when considering interchangeability of wearables (for example, “bring-your-own wearable” approaches to clinical trials)
• Clinically meaningful and patient-relevant composite endpoints derived from multiple sources
• Integrated analytical tools
• Visualization tools to advance transparency
• Reliable metrics to compare standard disease outcomes (for example, sleep quality, performance status) as measured by DHTs to traditional collection methods

LOIs and research proposals will be evaluated based on program fit, novelty, rigor, and clarity. Preference will be given to projects that address the criteria below.

• Equity: Projects should clearly address an unmet need related to diversity/equity in medical research, with a focus on underrepresented and/or underserved populations, which could include race and ethnicity, sex, age, sexual orientation, gender identity, disability status, socioeconomic status, geographic location, and other social determinants of health.
• Regulatory Applicability: Proposals should explain how study outputs could impact FDA regulatory decision-making to advance the use of DHTs in clinical research.
• Data: Proposals should demonstrate feasibility through preliminary data or provide detailed information on how data will be gathered/accessed for the study.
• Community Engagement: Projects that include collaborations with community and/or patient groups are preferred. Development of a community advisory board is encouraged.
• Industry Engagement: Projects that include collaborations with pharmaceutical, device, or technology companies are preferred. However, these companies cannot receive any funds from the award.

• Applicants (U.S. and non-U.S. citizens) must be employed full time at an accredited U.S. university or research institution.
• Applicants must be eligible to apply for independent external research funding from their institution.

Based on letters of intent, the PhRMA Foundation scientific advisory committee will select up to eight candidates to submit a full application, including a detailed research proposal and budget. Each of these candidates will receive a planning grant of $25,000 and have three months to submit their full application. From those submitted applications, up to two candidates will receive a $500,000 award.

$25,000 Planning Grants

• Planning grants are made payable to the PI’s institution.
• The Foundation will require submission of a financial report detailing how the planning grant was spent.
• None of the planning grant funds may be used for fringe benefits or indirect costs.
• If candidates do not submit a full application, the $25,000 planning grant must be returned to the PhRMA Foundation.
• For those interested, Amazon Web Services (AWS) will provide a $5,000 promotional credit to each candidate toward institutional use of AWS services. AWS will also provide scientific and technical subject-matter expertise to support the development of a proof of concept and/or refinement of existing cloud architecture on AWS.

$500,000 Award

• This award provides $500,000 over a three-year period, distributed on a quarterly basis.
• Funding is conditional upon the continued employment of the awardee (lead PI) with the university, which will be assessed on a quarterly basis prior to payment. Payments will be made directly to the university on behalf of the awardee, with the understanding that the university will administer the funds, including to other PIs or other institutions.
• If partnering with a company, the company may not receive any of the award funds unless they are a vendor. Details must be provided as a budget addendum.
• If partnering with community or patient groups, those groups may receive some of the award funds. These budgeted monies can be paid from the PI’s institution. (Monies to the partnering patient group(s) is contingent upon the awardee’s continued employment with the university.)
• A maximum of 20% of the award may be used for indirect institutional and/or fringe benefits. No more than $100,000 total may be used for these combined allowances over the three-year award.
• Funding is contingent upon the PhRMA Foundation receiving progress reports every six months and yearly financial reports. Progress reports will be reviewed by the Foundation’s scientific advisory committee to confirm satisfactory progress is being achieved.
• Yearly financial statements must be submitted to the Foundation.
• Any changes to the proposed project must be approved by the PhRMA Foundation.
• Funding may begin as early as July 1, 2024, or on the first day of any month thereafter, up to and including December 1, 2024.
• Unspent funds will be returned to the PhRMA Foundation upon the grant’s conclusion.
• These funds are non-transferrable.

Step One: Letter of Intent (LOI)

Deadline: September 29, 2023, at 12:00 p.m. (noon) EDT

To start an LOI, go to the ProposalCentral website at proposalcentral.com. If you are a new user of ProposalCentral, follow the link “Create an Account” and complete the registration process. If you are already a registered user, login with your username and password. If you have forgotten your password, click the “Forgot your Password?” link.

Once you are logged in, please click the “Professional Profile” tab at the top and complete steps 1-11 or update with your current information. Your name, degrees, position/title, academic rank, department, and address will be pulled from this page in ProposalCentral.

Next, select the “Grant Opportunities” tab and a list of applications will be displayed. Find “PhRMA Foundation” and click the “Apply Now” link next to “Empowering Health Care Equity: Harnessing Digital Health Tools for Inclusive Regulatory Decision-Making.”

Eligible candidates should submit the following materials:

• Candidate’s Biosketch (NIH style)
• Extended Letter (not to exceed two pages) telling us about yourself and how this project fits into your larger body of research.
• Letter of Intent (not to exceed six pages) providing an overview of the project, including:
  • What DHT(s) will be studied and why
  • Expected output and how the results could impact FDA regulatory decision-making
  • How the project addresses equity
  • Preliminary data or plan for gathering data
  • Information on collaborators such as companies (pharmaceutical, device, tech); community and/or patient groups; or other academic institutions
• Research Impact Questions (using template provided)
• Letters of Support
  • From applicant’s institution confirming commitment to three-year project. (This letter can be written by the department head, dean or other senior official.)
  • From collaborators (if known at the LOI stage). If you have collaborator(s) from another academic institution, not only is their letter of support required but they will need to include a letter from their leadership (department head, dean or other senior official) confirming the institution’s support of the project.
• Budget for the $25,000 planning grant (the only restrictions are that funds may not be used for indirect costs or fringe benefits)

A PhRMA Foundation Scientific Advisory Committee of experts will review the letters of intent and select eight candidates to be awarded $25,000 planning grants to support development of full research proposals to submit for consideration for the two $500,000 grants.

The LOI deadline is September 29, 2023, at 12:00 p.m. (noon) EDT. Late submissions will not be accepted.

Candidates will be notified by December 15, 2023, whether they are invited to submit a full application.

Step Two: Full Application (by invitation only)

Deadline: March 14, 2024, at 12:00 p.m. (noon) EDT

The eight selected LOI candidates will develop and submit full applications. If they do not submit a full application, the $25,000 planning grant must be returned to the PhRMA Foundation.