MedTech POV Blog

Increasing Diversity in Clinical Research and Addressing Health Inequities

  1. DeChane Dorsey Executive Director, AdvaMed Accel

Background and Goals

Starting in 2020, the global COVID-19 pandemic heightened the awareness of existing health disparities within the United States (US) healthcare system. Research has shown that people of color are less likely than white patients to have access to certain medical technologies, or undergo procedures that use medical technologies, than white patients.1 People of color – especially Black people – are statistically more likely to suffer from a wide range of chronic and infectious diseases and other health conditions, including cardiovascular disease, stroke, diabetes, kidney disease, cancer, and chronic lower respiratory disease. These diseases are some of the leading causes of death and disability in the United States.2

The medtech industry, at its core, exists to ensure patients have access to safe, effective, and innovative medical technologies that save and improve patient lives. The medtech industry has an important role to play in ensuring health equity and mitigating health disparities as we make the technologies and tests that result in the accurate diagnosis of disease and in improved patient outcomes for all patients. The Advanced Medical Technology Association (AdvaMed) launched the Responding To Racial Disparities In Health initiative in 2020 and laid out a set of four Principles on Health Equity to promote inclusion and equity in healthcare and research in the medtech industry.

Principle #1: Promoting Inclusion and Equity in Healthcare
Principle #2: Partnering in Education with Stakeholders
Principle #3: All Patients Deserve Access to Innovative Technology
Principle #4: Promoting Research Equity

cover of report

Generating evidence on medical technologies is critical for regulation, market access, and clinical adoption. AdvaMed partnered with Meharry Medical College on a workshop series convened in April, May, and June of 2021 that focused on increasing diversity in clinical trials. The workshops brought together a diverse group of interested stakeholders to discuss the need for and methods to achieve diversity in clinical research. Workshop topics included Ethics, Trust, & Engagement: Addressing the Challenges of Clinical Trial Diversity, Building Trusted Networks, and Addressing Diversity Through Patient Centered Trials. View recordings and key takeaways from the 3-part series.

Based on the insights from the workshops, this document is intended to outline some of the potential considerations and possible approaches to help research sponsors improve inclusion of under-represented groups in clinical research. It is our hope that it will empower individuals within our member companies to inspire and promote changes that will enable commitment to company missions with the goal of eliminating racial health disparities.

Be Aware and Acknowledge the History of Abuse in Clinical Research

Trust in the research enterprise has been compromised due to past abuses in clinical research, especially as it applies to ethnic and racial minority populations. Efforts to increase participation in clinical research by diverse populations must address this history.

Despite efforts of the FDA and the Revitalization Act of 1993, (which required that NIH funded clinical trials include women and minority participants), diversity in clinical trials has stagnated. A large segment of the population still lacks information, access to care and the opportunity to participate in clinical research. In assessing this phenomenon, we must consider factors which contribute to the lack of diversity including historic distrust on the part of some populations due to racially biased treatment. Moving forward, study sponsors need to communicate with patients the various policies and safeguards in place today to protect study participants and to protect against repeating those behaviors.  

As an initial step, research sponsors should evaluate their current clinical research portfolio, enrolled patients, study designs, site locations, and principal investigators to assess the diversity of the populations being included. A systematic assessment of the potential gaps in your current approach will help identify what needs to be addressed and will facilitate development of a more targeted plan.

Change External Expectations 

The recent policy and regulatory focus on health equity is expected to drive lasting impacts for patients and their health outcomes. These changes will also necessitate changes by medtech innovators. Regulatory agencies such as FDA1 and CMS2 and research funders like NIH3 have prioritized health equity and have made known their goal of promoting equity via strategic priorities and announced objectives.

Key factors to consider:

Sponsor

With greater participant diversity, there is increased understanding of how your medical device will impact different types of patients within your target population.

Working with diverse investigators can lead to not only more diverse participants, but also may lead to innovative solutions that better meet the needs of the target population.

With a greater understanding of the target patient population, your internal product development teams will grow in their understanding of the needs of varied populations and will influence updates to existing product design that can further meet patient needs.

Lastly, marketing and medical team members will be able to better describe the impact of your medical device to healthcare decision makers based on data collected.

Patient

Early in development, this learning can impact final design, leading to potentially better outcomes for all patients impacted by the target condition and treatment.

Under-represented populations would be included in clinical trials and a larger segment of the population could benefit from and have awareness of these innovations.

Patients’ needs will be addressed via updates to existing products.

Patients will benefit from using high quality medical devices.

Understand Diverse Health Care Needs and Patient Populations

As an industry, we acknowledge that the most important part of our work is to create technology that improves patient health outcomes. This involves the development of innovative technologies as well as understanding the needs of all the patients the products will treat.

Establish the Current Baseline and Set a New Benchmark

Plan for Diversity in New Clinical Trials

Current research, development strategies and the way in which they are implemented have long histories for many companies—including relationships with clinicians, facilities, and researchers. Examining current practices may identify gaps that undermine efforts to capture more representative patient populations in your studies. Sponsors should consider:

Strategies for Recruitment of Diverse Populations

Accomplishing successful recruitment not only requires us to potentially modify and rethink our research partnerships to include sites that serve diverse patient communities, but it also requires sponsors to be more proactive in efforts to engage with patients to communicate the value of research. Recruitment information should be readily accessible by patients and easily understood. It should be culturally sensitive and available in several languages and dialects depending upon the diversity of the area and the diversity of patient population. Establishing longstanding mutually respectful patient-clinician relationships is important for establishing trust in diverse communities. Patient outreach and trust building opportunities between clinicians and communities before clinical trials start is vital for successful enrollment.

The following considerations for recruitment strategies have been identified:

Innovations in Clinical Study Design and Execution

Changing how clinical research is designed to reduce patient burden and improve engagement can help support more representative results and advance innovation. A number of innovative trial approaches such as decentralized clinical trial (DCT) models are a step in the right direction towards taking the research to the patients that need it. Sponsors should weigh the use of new digital technologies and solutions such as remote patient monitoring and telemedicine for follow-up care.

By embracing new digital technologies, sponsors could both reduce the burden to patients and also to trial sites. In place of time-consuming office visits, telemedicine appointments can replace and/or supplement patient follow-up when appropriate. Directly capturing RWD such as patient-generated health data (PGHD) through apps and wearables can give you more information about daily activities and can ease the challenges of long-term follow-up for patient-reported outcomes.

While some of these technologies may address some of the barriers for participation, they are not a perfect solution. Sponsors should consider patient aversions, access limitations, and sensitivities regarding these technologies.

Key Recommendations

Learn more about AdvaMed’s Health Equity work.

DeChane Dorsey is executive director of AdvaMed Accel, the division for small and start-up medical device technology companies. She also leads health equity work organization-wide.

Citations

1. Riskin, Dan. “Real-World Evidence Studies Can Enhance Diversity and Equity in Clinical Research.” Applied Clinical Trials Online. Oct 23, 2020.

2. Centers for Disease Control and Prevention. 2022. “Leading Causes of Death.” January 13, 2022.

3. FDA resources:

4. CMS resources:

5. NIH resources:

6. Centers for Disease Control and Prevention. 2021. “Social Determinants of Health: Know What Affects Health.” September 30, 2021.

7. Ziemssen, Tjalf, Jan Hillert, and Helmut Butzkueven. 2016. “The Importance of Collecting Structured Clinical Information on Multiple Sclerosis.” BMC Medicine 14 (1): 81.

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