New Digital Tools Advance DEI in Global Clinical Trial
#Methods
Julia Donahue (left) and Karma Lhamo are working to increase diversity, equity, and inclusion in global clinical trials.
Tackling racial bias in health care takes many forms. The Stanford Center for Clinical Research (SCCR) is doing its part from the research side by working to increase diversity, equity, and inclusion (DEI) throughout its programs – from observational research studies to clinical drug and device trials.
“Despite best efforts, certain demographic groups continue to be underrepresented in clinical research,” says Julia Donahue, senior project manager at SCCR. “We want to ensure we have full representation from all different backgrounds when testing the efficacy and safety of drugs, devices, and other interventions. Collecting the highest-quality data benefits patients – not just at Stanford but around the world.”
“We know from medical literature that participants from certain racial and ethnic minorities tend to be underrepresented in clinical trials, especially in cardiology,” explains Sneha S. Jain, MD, clinical assistant professor of cardiovascular medicine. “To mitigate this disparity, the FDA now requires minimum representation from certain groups in clinical trials. For example, Black participants should comprise at least 6 percent of our trial population in the U.S.”
“Additionally, we’re looking to enroll more women in clinical trials,” says Donahue. “A recent study found that just over 41 percent of people enrolled in clinical trials for investigational drugs for cardiovascular disease are women, despite representing 51 percent of the patient population. We know we can do better.”
Clinical Trial for A-fib Drug to Have DEI Focus
SCCR has an exciting opportunity to boost DEI participation in a global clinical trial sponsored by Janssen Research and Development, LLC, and Bristol Myers Squibb called LIBREXIA-AF. Stanford is one of hundreds of sites involved in testing the effectiveness of a new anticoagulation drug for patients with atrial fibrillation (A-fib or AF), and it’s been tapped to serve a leadership role in participant recruitment. Jain, a member of the executive team for the LIBREXIA-AF study, is one of many SCCR staff and Stanford faculty working on multiple clinical trials involving nearly 50,000 patients for this comprehensive drug development program.
Says Marco Perez, MD, associate professor of cardiovascular medicine, “We’re involved in much of the operations, the scientific development, clinical events adjudication, biostatistics, as well as DEI efforts, not only for atrial fibrillation but also for separate clinical trials related to stroke and acute coronary syndrome.”
A DEI focus is particularly important for the A-fib trial, explains Perez, because “underrepresented groups are less likely to be prescribed anticoagulation medication, and we want to find new outreach methods to help us identify people who would benefit from this drug.”
Introducing the Stanford Heartbeat Study
To achieve its DEI goals, the SCCR team engaged the Stanford Medicine Technology and Digital Solutions team to develop a set of digital tools that would allow Stanford to recruit more minority participants. Digital recruitment methods have proved successful with past clinical trials, allowing Stanford to cast a wider net in recruiting participants for the Apple Heart Study and Project Baseline.
Digital tools will enable Karma Lhamo (left) and Julia Donahue to recruit more women and minority patients to participate in clinical trials for atrial fibrillation.
“We want to ensure we have full representation from all different backgrounds when testing the efficacy and safety of drugs, devices, and other interventions. Collecting the highest-quality data benefits patients – not just at Stanford but around the world.”
– Julia Donahue
The first phase of SCCR’s digital recruitment efforts – the Stanford Heartbeat Study website – is launching in fall 2024.
The website makes it easy for people to express interest in participating in clinical trials related to atrial fibrillation. Describes Karma Lhamo, SCCR senior project manager for the Stanford Heartbeat Study, “The website is a digital platform that facilitates various functions of the study such as participant identification, screening, enrollment consent, and data collection. Potential participants can review and provide informed consent for the Stanford Heartbeat Study, confirm they have atrial fibrillation, and are at least 18 years old. If they meet those criteria, they’re directed to provide baseline screening information specifically tailored for LIBREXIA-AF, including their gender and ethnicity.”
The SCCR team hopes the website will generate excitement about clinical trial participation. Says Jain, “When you participate in research, there is a chance you will be randomized into a cohort that provides state-of-the-art therapeutics. With the LIBREXIA-AF study, participants will either be taking a drug that is the standard of care for atrial fibrillation today or a new drug – where we already have rigorous safety data – that could potentially be the best new therapy that we have.” The LIBREXIA-AF Study is a global, Phase III, randomized, double-blind, parallel-group, event-driven clinical trial comparing milvexian (an investigational oral Factor XIa inhibitor) with apixaban (an FDA-approved oral anticoagulant) in participants with atrial fibrillation or atrial flutter.
Digital Tools Will Revolutionize Clinical Trial Recruitment and Engagement
Recruitment efforts for clinical trials traditionally occur in clinical inpatient and outpatient settings, making the process labor-intensive and site-specific. The Stanford Heartbeat Study enables recruitment over a wider geographic area and with an increased range of outreach partners. Explains Jain, “We want to partner with groups that serve A-fib patients, and the Stanford Heartbeat Study is a resource to engage people in the research process and make recruitment and enrollment easier.” While Stanford is using the tool to identify candidates, those who join the clinical trial will participate at the research site closest to them.
The second phase of the Stanford Heartbeat Study is a mobile app scheduled for release in early 2025. The app is designed to be an engaging and educational tool for LIBREXIA-AF participants as well as for those unable to enroll in this A-fib clinical trial but who might be eligible for a future one. An added benefit for those who join the Stanford Heartbeat Study through the mobile app is the option to have data collected from their wearable device, such as a smartwatch.
“We want the app to help us build a community for people with atrial fibrillation,” says Perez, who is the principal investigator for the Stanford Heartbeat Study. “We hope it will serve as a hub that will allow people to track all of their A-fib-related information: their medication doses, procedures such as cardioversion and ablation, as well as data from their mobile devices.”
The app will enable Stanford to expand beyond hospital- and clinic-based recruitment by reaching out directly to potential clinical trial participants. “This is a completely different approach to outreach where we’ll be using new strategies like social media ads,” notes Perez. “So, for example, people who search for the term ‘atrial fibrillation’ on Google or who have a certain profile on Facebook will see an ad for our study.”
Participants will be able to upload their A-fib data from a wide variety of devices, including Apple, Android, Samsung, and Fitbit. Targeted messaging will be used to enlist those who are located near an enrolling site or whose data show they are now eligible for a clinical trial.
Ultimately, says Jain, “we’re hoping the Stanford Heartbeat Study is a pathway to help us build a diverse community of people who are excited to contribute to research and advance science by participating in clinical trials.”
More About LIBREXIA-AF
The LIBREXIA-AF study will compare a new blood thinner medication, milvexian, with one commonly prescribed today (apixaban, also known as Eliquis). Patients with atrial fibrillation, a common type of heart arrhythmia, may be prescribed this type of anticoagulation medication to reduce the risk of stroke and blood clots. The study will evaluate if milvexian is at least as effective as apixaban and if it is associated with less bleeding risk.
Stanford Uses Team Science Approach in LIBREXIA-AF Study
SCCR’s program is an example of Stanford’s team science approach to medicine, with participation from more than 20 Stanford faculty and staff in cardiology, neurology, primary care, emergency medicine, and data sciences, along with trial operational experts. Says Kenneth Mahaffey, MD, director of SCCR and principal investigator for the LIBREXIA-AF trial, “This program highlights the potential for impactful, rigorous science through collaborations between academia and industry and is a great opportunity for Stanford. The breadth and depth of our involvement is also going to provide great mentoring and training opportunities for our young faculty, trainees, and staff.”
Save as PDF