In 2021, MedTech Color Collaborative Community held a moderated discussion featuring thought-leaders on clinical research and health equity. This engaging discussion was designed to educate diverse patient groups about the benefits of participating in clinical research by “demystifying” a process that many communities of color may view with suspicion based on historical events, lack of information and current misconceptions. We have summarized the highlights and takeaways from this program to help facilitate concrete efforts to promote more diverse and inclusive approaches to medical device development.
(1) Diverse and Inclusive Clinical Trials Lead to Better Products and Better Outcomes
- In order for clinical trial results to be the most valid, it is important that the participants and volunteers represent the full spectrum of people that will be affected by the disease or product being researched.
- Unfortunately, the available data show that this is not often the case and that representation among black, latinx, and other historically underrepresented groups is poor.
- In most clinical trials conducted to evaluate medical devices and other medical products, it is typical to have broad representation of whites, significantly less representation of black or African American and even less representation of Asians across a broad spectrum of therapeutic areas.
Leslie Wise – “We’re moving to a place where in this [most recent] census [shows that] the country’s population came out 40% diverse and in 10 years it’s going to be more than 50%, so at this point it’s a business imperative. From an industry standpoint, these are things that need to be figured out, because these are the realities of the changing demographics.”
Patrick O. Gee – “The overall benefits for a diversified clinical trial, is that (1) it restores faith in the medical community to understand the impact of the risk of side effects, and (2) establishes better patient clinician communication, and (3) you hear from [the] community what is effective for product development.”
(2) Past Abuses Have Created Distrust
- People of African descent tend to be leery of participating in clinical trials based on historical abuses that are a familiar part of the cultural vernacular of many black communities.
- There are famous examples such as the Tuskegee Experiment and not so famous examples such as a study conducted by a radiologist at a prominent university between 1962-1971. The experiment involved exposing 88 black and poor cancer patients to X Rays at rates that far exceeded safe levels to determine how much radiation they could tolerate.
Patrick O. Gee – “Because of these abuses, “we must be bold now. We really must go into the communities, and we need to educate the Community….We really need to diversify clinical trials.”
Elsie Ross – “As someone who works in an academic medical center, I’ve often seen that physicians, like myself, assume a lot about the patient and their knowledge and their thoughts…. We just assume that everyone knows that they’re an important part of healthcare and moving the needle forward. It’s a bad assumption, because a lot of people will come from families where access to healthcare has been poor, so there’s a lot of distrust. To educate towards Community building, we have to start at ground zero, meet people where they are in terms of their understanding of what’s going on, and talk to them about the basics before…shoving a pen and paper in their face to sign a consent to be enrolled in a trial.”
(3) Building Relationships with Clinicians that Serve Underrepresented Communities is Key
- Representation among clinicians from underrepresented groups is important to provide informed perspectives on disease progression.
- Insights from clinicians who have a clear line of sight regarding the nuances of disease progression within underrepresented populations is important to understanding and characterizing the potential clinical benefits of products under development. That perspective is critical to appropriate trial design.
- A key step in having more diverse clinical trial populations is having more diverse researchers. An important step for both objectives is to build relationships with the clinicians that work in those communities.
- In order to build trust, it is helpful to understand the barriers that may prevent volunteers and clinicians from participating in clinical research.
- Social determinants of health are a significant factor in access to care and participation among historically underrepresented groups.
Leslie Wise – “I think [the lack of relationships between product developers and clinicians from historically underrepresented groups is] the biggest barrier to participation, because those clinicians [are] where the relationship of trust exists. These patients trust their doctors. And the fact that their doctors are never part of these clinical trials encourages them to not be part of the clinical trial.”
Patrick O. Gee – “If your clinical trial team is not diverse, you will not be able to recruit diverse participants. One of the things that people of color do now is when you introduce a clinical trial, they want to investigate the clinical trial, and if the team isn’t diverse nine times out of 10 they will not participate.”
(4) Education is Essential to Building Trust and Transparency
- It is important to develop new and progressive strategies to educate and engage historically underrepresented communities about the benefits and risks of clinical research.
- Clinical trial education materials and informed consent forms must be accessible by diverse populations with different needs. “Diversity” means different things to different people and these communities are not a monolith.
- Patient-facing materials should explain the “patient journey” in a clinical trial to help them better understand the clinical trial process. Materials should include language that is clear, accessible and culturally appropriate.
Sonia Houston Pichardo – “Industry does have a role in helping better understand and doing a better job [of educating]. Instead of just saying “come, we want to recruit you”, [industry should be] saying “we want to be a part of your education”. It must be multilingual and reflect the communities that you’re trying to have a conversation with.”
Elsie Ross – “We want you [the patient] to also be an advocate for yourself, and not just feel that there’s one road through one clinic, physician, or institution. We want patients to know that there are many ways to engage in the system and learn more about trials and health care in general.”
Patrick O. Gee – “When you talk about social determinants of health, you don’t know if people may not be able to participate. [I]f you live in a rural area, maybe you don’t have a phone system or you lack broadband, maybe, if you live in an inner cities or low income communities, you may lack transportation, access to healthcare, lack of information about health literacy or even if you wanted to participate in clinical trial, maybe you may not know where to go and find out about these things.”
FOUR STEPS TO PROMOTE MORE DIVERSE AND INCLUSIVE CLINICAL TRIAL RECRUITMENT AND RETENTION STRATEGIES
1. Incentivize Clinical Sites by Setting Goals for Enrollment of Underrepresented Cohorts by:
- Sharing information about the burden of disease being researched in the whole population, so that the site fully understands the demographics of patients that should be included.
- In discussion with sites around the demographics of patients in their individual practice, consider setting site-specific targets for enrollment, incorporating data around burden of disease in that population.
2. Provide Training and Educational Materials to Study Teams, with Tips and Tools for Recruitment and Enrollment of Underrepresented Cohorts, including:
- Speaking to sites about the demographics of the staff working with patients in clinical research.
- How to use data to understand the burden of disease in the whole population, and making sure that investigators have access to that data for their own population of patients.
- How to engage with communities so that they can understand the purpose of the clinical research being conducted and feel supported as participants in a study. Companies conducting research should not just be present in a community for the duration of the study – networks of information and support should be established and maintained for the long term. Communities should not feel like they are being involved in clinical research and then their health concerns are neither considered nor addressed following the study.
3. Develop a Strategic Plan for Outreach to Physician Community Hospitals or Organizations that Serve Underrepresented Communities that addresses:
- Engaging in proactive outreach to medical societies, medical schools within Historically Black Colleges and Universities (HBCUs), and patient advocacy organizations to foster better understanding of these barriers and potential solutions to address them.
- Make such outreach a part of strategic annual goals for relevant personnel and/or divisions to incentivize and encourage concrete actions.
- Focus research planning activities on hospitals or other sites that serve historically underrepresented communities.
4. Develop Resources to Articulate the Benefits of Participating in Clinical Research to Underrepresented Patients and Clinicians, by:
- Establishing a framework for engaging with communities of underrepresented patients and clinicians to provide resources and networks for clinical research over the long term. As previously stated, communities should not feel like they are being involved in clinical research and then their health concerns are neither considered nor addressed following the study.
- Engage with communities before a clinical trial protocol is finalized to ensure that inclusion and exclusion criteria for a particular study do not exclude underrepresented populations.
- Consider using patient advisors from historically underrepresented communities to help inform recruitment and outreach strategies for those communities.