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.