Strengthening Patient-Sponsor Ties and Helping Communities Create Legacies of Health
Leveraging insights from patients can help sponsors create trials that truly impact patient lives. Legacy Health Strategies’ CEO Jessica Scott, MD, JD, and Vice President, Culture, Inclusion & Equity Marsha Calloway-Campbell, JD, describe how they’re leveraging bidirectional communication to help patients create legacies of health in their communities through their new initiative, My Health, My Legacy.
What challenge are you aiming to solve with your work at Legacy Health Strategies?
Jessica Scott: We’re addressing the challenge of how to operationalize insights gathered from patients and communities in drug development, how to increase diversity, and how to foster bidirectional communication that is engaging, educational, and empowering for potential participants, before, during, and after clinical trials.
Traditionally, sponsors have not been able to communicate directly to patients because sponsors are restricted from having any identifying information about patients. But with a digital communication platform as a bridge between sponsors and patients, now we can facilitate this more direct connection without sponsors needing to have identifying information.
The result is that patients feel more connected to the clinical trials, more knowledgeable, and ready to ask informed questions once they arrive at a site. Sites are also less congested because more patients are likely to be interested and ready to make a decision about participation should they qualify. Similarly, this same bi-directional communication is helpful during and after a trial to stay connected and engaged with the development of new treatment and therapies particularly for their condition.
How are you doing this?
JS: We utilize a customized digital platform that allows us to meet people where they are and invite them to learn more using clear, inclusive communications and engaging, relatable content that’s highly relevant to what people living with a given condition want to know. This same communication platform helps guide individuals to learn more about their potential eligibility for a trial and helps sponsors continue to share information with patients and to receive information back from them through short survey questions.
This capability makes the preliminary assessment of inclusion and exclusion criteria possible through patient self-reported responses. If a person is living with a condition that must meet certain criteria for inclusion such as level of severity as measured by a patient reported outcome measure to participate, or if they must be willing to forgo a medication they are currently taking, questions such as these can be asked before referring to a clinical trial site. At the same time, information about the design of the trial, the informed consent, or proximity of a site to where they live, this information is also shared via the platform.
What kinds of information could be shared with participants during a clinical trial that helps enhance retention?
JS: We gather insights from people living with a condition, so that we can develop a strategy for the on-trial and post-trial experience that supports participants throughout the process. People often feel very alone during a trial. They want clear and consistent information about what to expect at each study visit, information from the informed consent, the rationale for procedures and high-level updates. They also want to be asked about their experience, which contributes to feeling valued and respected and has been shown to decrease dropout rates by 50%.
Where possible, sponsors can make changes and improvements that demonstrate reflective listening, such as the availability of transportation assistance where participants communicate through close-ended survey questions that this is a challenge for them.
Another example of reflective listening is where participants express the need for greater clarity and expectation setting as to the amount of time to anticipate upcoming site visits, so participants aren’t caught by surprise when a visit is 4 hours instead of 30 minutes. We’ve even had a participant-facing interim update webinar corresponding to a scientific community update. The important thing is that sponsors are able to address issues that might be causing participants to feel disconnected from the trial or overburdened where they may be considering dropping out of the study.
What’s the benefit to sponsors?
JS: First, sponsors are able to reach many more potential participants to engage and educate around clinical trials. When people understand and feel empowered in their health care journey to consider clinical trials, they can bring the clinical trial information to discuss with their clinician, family or community members.
Sponsors can also help to decrease the congestion at sites to screen many more people without a particular order of who is more ready to make a decision and qualify for the trial. Sponsors are also helping participants to be prepared for upcoming site visits and supporting more consistent and comprehensive communication and engagement across sites. Lastly, with more rapid recruitment and fewer people dropping out, sponsors and patients benefit from more new medicines to market, sooner. The higher quality and more complete data can also help regulatory decision-making.
How does this work tie into the initiative “My Health, My Legacy?”
JS: As we get into more personalized medicines, we know that we need to broaden the funnel and bring in individuals that may not be aware of/or may not have an openness to learning about clinical trials.
MyHealth, MyLegacy is an opportunity to understand how we reach a broader community: the messaging and the communication that will help people and empower them on their healthcare journey. Marsha is a builder of community, and from that community-building, we hope to foster an openness to partner with industry in helping to bring innovative science through clinical trials.
What are you trying to achieve with “My Health, My Legacy”?
Marsha Calloway-Campbell: The primary focus is to create a legacy of health in our families and communities of color, on a journey towards health empowerment.
In communities of color, we talk about health and wellness. We want to improve those long-standing traditions and habits that we know aren't healthy. We make attempts at how to eat healthier and become more active, but a lot of us learn to cook from our mothers and grandmothers, so it's very nostalgic. That was the legacy they left to us. We are trying to prioritize health and wellness, especially because we're becoming more and more aware of those conditions that disproportionately affect our communities. And so, MyHealth, MyLegacy focuses on being intentional about leaving behind a legacy of health, by being engaged, educated, and empowered, both on the individual level and on the community level.
Other companies and groups are also doing this type of engagement. How are you doing it differently?
MCC: We're going to focus on five or six conditions that disproportionately affect people of color: cancer, cardiovascular/heart disease, diabetes, fatty liver disease and sickle cell disease.
It’s also a two-pronged approach: grassroots and professional. What I mean by grassroots is we are looking into local resources when we need to engage with a community, finding the collaborators who are close to the communities. And when we say professional, I mean interaction with professional organizations and other advocacy organizations that are active in our communities. As an example, I’m a member of one of the Divine 9 organizations, which represent the nine historical black sororities and fraternities. Each organization operates on national, regional, and local levels. I belong to one of the local chapters of Alpha Kappa Alpha Sorority, Incorporated in the Cincinnati area. Also, many Black and Hispanic professional organizations have a local, regional, and national presence with a mission of serving our communities as it relates to the health and well-being of the people. Having a health platform or target is common for these organizations and collaborating with them is beneficial to the community.
Tell us about your story as to why education around health empowerment is so fundamental to this conversation?
MCC: Knowledge is power. And if we can empower patients with health literate information, they can ask the right questions about clinical trials, but they won’t know what questions to ask if they’re not educated.
My husband was diagnosed with multiple myeloma, and I had never even heard the words before that point. Multiple myeloma affects Black people 2-3 times more than any other population. There should be awareness and education in our communities about it, about what it is and what the typical signs and symptoms are, like anemia, bone pain, high calcium, etc. If I had known this, I could have said to my husband’s doctor, “Could this be multiple myeloma?” when my husband presented with back pain and fatigue.
What action do you want to see from pharma?
MCC: The goal is to incorporate the voice of the patient early in the clinical trial process, and it’s critically important to include the voices of diverse patients. Diverse patients don’t typically participate, so our voices are very important during the design of a clinical trial. Before anything, you need to stop and listen to whatever community you’re trying to reach and educate about clinical trials. In addition to understanding the level of knowledge regarding clinical trials, it’s first essential to hear the experiences and health journeys of patients in the community. You must understand pain points and unmet needs and learn ways of supporting and having a presence in the community. This paves the way for clinical trial awareness and education.
Also, it is important for clinical trial sites to have an ethnically diverse staff if they are attempting to recruit Hispanic and Black patients. The staff should represent the patients that the site serves. That’s one big step towards getting people of color to participate in clinical trials, which leads to better recruitment and retention, and ultimately, better health outcomes overall.
What does success look like for you with My Health, My Legacy?
MCC: Success looks like highlighting these conversations in the communities and educating people by developing and distributing information that's understandable, relevant, and easily accessible.
Success looks like utilizing clinical trial ambassadors or champions – people who have already participated in clinical trials - to share with the community about the conditions we’re focused on and about clinical research.
Success would be helping pharma to show up in the community early, often and in a credible way, and demonstrate long-term commitment.
Any further thoughts on “My Health, My Legacy?”
MCC: As I experienced when working in Market Research at Procter & Gamble, word of mouth advertising is prevalent in especially Black and Hispanic communities. It’s about who we know, who they know, and the desire to offer to others help within the community. People are more open to sharing experiences with those who look and think like them. “You had cancer? How did you navigate the disparities that are unique to us?” So, if you can create those communities within different cultures, you can create a sense of belonging and a common goal for which to contribute.
JS: All these efforts are about connecting with people who can benefit from and help drive new innovations in science and patient care. We want to directly reach individuals where they are: via online social health, and local community, as well as from patient organizations, satellite healthcare clinics, and even trial sites. A site running trials may not have the bandwidth to spend multi visits sharing information about a trial and answering questions and may prefer to refer individuals to a website with information written in plain, living-room language where the questions people typically ask are addressed in clear, inclusive language where people can understand content the first time they read it.
Now, with the Legacy communication platform, there are multiple ways that individuals could come into that research funnel as opposed to the more traditional manner where people just happen to land in the office of the right physician investigator who happens to be running a clinical trial for which they may be eligible. We want to give people more control in finding and enrolling in clinical trials with the information they need to make informed decisions that are right for them.
