# Utilizing the Pharmacy Advances Clinical Trials (PACT) Network to Achieve Diversity in COVID Clinical Trials: A Strategic Framework

> **NIH FDA U01** · TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR · 2022 · $1,000,000

## Abstract

ABSTRACT/SUMMARY
Drug development and clinical trials have been central to the exponential decline in morbidity and mortality
associated with COVID-19. While disproportionate COVID-19 mortalities have been observed in
underrepresented minority (URM) communities, enrollment into COVID-19 clinical trials has been challenging.
Such challenges have been associated with patient, system, provider, and community barriers, including
mistrust, social determinants of health, failure to meet eligibility criteria, and lack of awareness of studies. To
address these issues, Texas A&M University (TAMU) has partnered with the American Association of Colleges
of Pharmacy (AACP). The primary goals of this project are to employ Artificial Intelligence (AI) and Machine
Learning (ML), develop a national network that would engage innovative strategies, and to train and educate
researchers to advance COVID-19 health equity research in URM communities. TAMU – College of Pharmacy
(COP) has established several outreach program activities designed to educate and enroll URMs in ongoing
clinical trials. The NIH recently funded TAMU-COP to conduct a Moderna COVID-19 Vaccine clinical trial. TAMU
recruited 25% of participants, approximately 35% are classified as URM participants, majority Hispanics.
The long-term goal is to (i) Employ innovative approaches, training, and education methods to increase URM
clinical trial enrollment. (ii) Improve communication strategies and informed messages for URM
populations. The central hypothesis is that the hesitancy of URM participation in clinical trials stems from long-
standing mistrust, lack of culturally competent messaging, lack of access to care, and underrepresentation of
authentic health champions. In addition, community-based pharmacists and pharmacy faculty have a unique role
as community clinical researchers in recruiting URM populations as participants in COVID-19 clinical trials. The
central hypothesis will be tested via the following two aims: Aim 1: Leverage Artificial Intelligence and
Machine Learning to enable environmental scans in target communities to optimize URM participation
in COVID-19 clinical trials. Aim 2: Create and train a network of community-based investigators,
pharmacists, and other partners to directly increase clinical trials participation among URM
populations. These aims will be pursued via innovative AI/ML analytics, training, education, and community
network. The immediate expected outcomes will be a better understanding of the critical elements of COVID-
19 clinical trials hesitancy in URMs and effective interventions for addressing hesitancy. It is anticipated the
proposed interventions will positively impact enrollment in clinical trials.

## Key facts

- **NIH application ID:** 10532565
- **Project number:** 1U01FD007574-01
- **Recipient organization:** TEXAS A&M UNIVERSITY HEALTH SCIENCE CTR
- **Principal Investigator:** GEORGE O UDEANI
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 1
- **Project period:** 2022-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10532565

## Citation

> US National Institutes of Health, RePORTER application 10532565, Utilizing the Pharmacy Advances Clinical Trials (PACT) Network to Achieve Diversity in COVID Clinical Trials: A Strategic Framework (1U01FD007574-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10532565. Licensed CC0.

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