The American Heart Association (AHA) announces a Request for Applications (RFA) for a Strategically-Focused Research Network (SFRN) on the Science of Diversity in Clinical Trials (SDCT).
The United States is a recognized leader in fundamental biological and biomedical discovery. Despite this abundance of discovery science, the US has been considerably less effective in translating those discoveries to clinical practice. A particularly challenging problem is the fact that clinical trials, the seminal first step in delivery of new medicines and therapies, typically do not adequately include the diverse populations who live in our communities (Arevalo et al., Contemp Clin Trial Comm 4: 52, 2016; Clark et al., Curr Prob Cardiol 44:148, 2019; Knepper and McLeod, Nature, 557: 157, 2018; Taani et al, Contemp Clin Trial Comm 17: 100533, 2020). Because safety and effectiveness may vary in different populations, the lack of diversity in clinical trial enrollment compromises the health care that can be delivered to those who are excluded. Whereas this problem has been recognized for decades, little progress has been made in overcoming this critical deficiency.
Given that the U.S. Census Bureau estimates show that 50% of the US population will be other than non-Hispanic white by 2045, it is imperative that clinical trials reflect the needs of an increasingly diverse population. Moreover, whereas the challenges of diverse inclusion of trial participants is prominent in the United States, a lack of sufficient diversity is also consistently observed in internationally-conducted clinical trials (FDA 2019 Drug Trials Snapshots, https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snaps...). This is thus an issue with far-reaching implications for the health of the global population.
With the establishment of the SFRN on the Science of Diversity in Clinical Trials, the AHA will identify solutions underlying the inequitable participation of diverse individuals in clinical research, and the associated health inequities it creates. This initiative will be instrumental in achieving AHA’s 2024 Impact Goal: to advance cardiovascular health for all, including identifying and removing barriers to health care access and quality by 2024.
GENERAL OVERVIEW – This SFRN on the Science of Diversity in Clinical Trials will consist of at least three centers, each of which will propose novel research strategies to engage individuals from under-represented groups in clinical trials such that their participation in clinical trials aligns with the diversity of our communities. Funded centers will be expected to collaborate on solving the core issues underlying this problem, many of which are delineated below.
NETWORK CENTERS – Each center application will include two or three research projects. Proposed projects will have a common fundamental theme that will assess an intervention or approach to addressing diversity in clinical trials. Projects may all be from a single institution, or they may be from multiple institutions. Each center project will be led by a Project Principal Investigator (PI), and must have the necessary research team, required infrastructure and ability to recruit and retain a diverse group of study participants. An overall Center Director will also be a key component of each center. Each Center Director will facilitate activities within his/her/their center and work closely with the other Network Center Directors to facilitate activities across the Network, including end-of-network deliverables.
TRAINING CENTER – The Training Center will incorporate a multidisciplinary approach to provide robust research experiences, training, and mentorship to create the next generation of clinical trialists. The Training Center will develop science curriculum and career development training opportunities while working closely with Center Fellows and their mentors to optimize their success. As detailed below, all SDCT Fellows will be from groups who are under-represented in science and medicine.
An institution may submit only one Center (and related Projects) application and only one Centralized Training Center application in response to this RFA.
Deadlines:
The intent of this initiative is to support a collaboration of basic, clinical and population (or implementation) researchers whose collective efforts will lead to new approaches to the study of cardiooncology. Each Center must propose two (2) or three (3) projectsrepresenting at least two of the following research disciplines: basic, clinical, and population science. All projects must focus on disparities in cardiooncology. Population studies are inclusive of projects ranging from cohort studies to translational or implementation research involving community interventions. All projects must address health and health care disparities and/or health equity in the cardio-oncology domain.
There are two (2) funding opportunities through this RFA:
1. Network Center
2. Training Center*
* Those submitting a Network Center application are also permitted to apply for the Training Center.
An institution may apply for one or both funding opportunities.
A Director may only be a director on ONE of the above, even if the institution is funded for both a Network Center and the Training Center.
Directors and Principal Investigators of projects of the Centers:
The maximum budget amount a Center applicant may request is $4,300,000. The AHA reserves the right to determine the final award amount for competitive projects based on need and potential impact.
