Making clinical trials equitable is one of the biggest challenges we face as an industry. We see this time and again, with one of the latest examples coming in the form of a study published in JAMA Network Open that found substantial underrepresentation of Black patients enrolled in pivotal trials for CAR-T therapy.
Women are another demographic negatively affected by inequality in clinical research. Earlier this month [May 2022] the American Heart Association issued a presidential advisory warning that gaps in cardiovascular disease research are putting the lives of female patients at risk. There are socio-economic disparities, too. For example, those with household incomes below $50,000 dollars per year are 27% less likely to participate in clinical trials.
We have, however, started seeing positive change in recent years, including public commitments to increase recruitment from underrepresented groups.
Flexible models and the use of virtual tools are vital for increasing equity in clinical trials. Providing participants with choices around their clinical care is key for reaching groups that have been historically underserved by the clinical trials industry.
Meeting participants ‘where they are’
Meeting participants where they are on an emotional level calls for us to provide them with a care team that they can relate to and that understands their specific concerns. For example, people are more inclined to volunteer for trials if the clinical trial investigator speaks their native language. Focusing on connecting with people in this way has a direct impact on the success of clinical trials – particularly when it comes to increasing access and reaching underserved groups.
Approaching recruitment in a holistic way not only enables us to increase access to trials but also boosts retention rates. Developing sensitive, targeted digital content for social media campaigns that engage participants online is a primary focus for recruitment teams. At the same time, we encourage ever greater levels of commitment and creativity when thinking about community engagement and meeting participants in their neighborhoods.
Engaging with communities through a grassroots approach builds personal relationships, scales trust, and provides an opportunity to share information and awareness about the importance of participation in clinical research. . Producing a model for more inclusive clinical trials starts with the human connection. Great strides forward are being made across the industry as a result of implementing new models that have a strategically creative and compassionate approach to clinical research as a healthcare option. The National Center for Biotechnology Information (NCBI) reports that decentralized models recruited participants three times faster than the traditional model. Bringing the trial to the patient accelerates study recruitment times and minimizes attrition, with the NCBI study showing that trial retention rates were 89% for the decentralized model and only 60% for the traditional model.
The importance of ‘the third place
We contend that ‘the third place has the potential to boost these figures even higher, as organizations like ours are actively working to maximize outcomes for participants and sponsors of clinical trials. Sociologist Ray Oldenburg defined “the third place” as an informal public gathering place that serves the community. He said it is the social surrounding that is distinct from the two main social environments of home (the “first place”) and the workplace (the “second place”).
By giving people the choice of participating in clinical trials at a third place, they are no longer limited by where they live or, in some cases, not comfortable having someone visit them at home. One innovative example of this is MMCs (mobile medical clinics), modified RVs (recreational vehicles) that are fully functional clinical study facilities. MMCs are coming to the forefront along with other community brick-and-mortar sites. Mobile medical clinics are a third place where we can bring people and technology together, effectively and seamlessly, in a clinical trial.
The virtual-first model delivers additional oversight and care that enables us to provide a consistently high level of experience. Flexible approaches, particularly those that incorporate the third place, have the potential to increase access to clinical trials in emerging markets with limited infrastructure.
These new approaches are helping us to bring clinical trials to all, particularly the most vulnerable populations. They provide participants with a greater sense of support, understanding and confidence about participating in a clinical study. Removing geographic and logistical burdens scales access which drives equity. Diversity in clinical research is essential for developing medications, treatments and therapies that benefit everyone.
About Rachael Scott
Rachael Scott serves as chief commercial officer at Lightship. She leads customer design solutions, business development and strategic marketing. Rachael excels at the intersection of strategy and operations to develop robust commercial structures designed for successful and streamlined collaboration with sponsors. Rachael’s expertise includes leading business development initiatives and integrated marketing platforms while building departments to scale. Prior to joining Lightship, Rachael served as a partner at PA Consulting Group and a director at Ernst & Young. Rachael delivered results working with pharmaceutical and biotech organizations to deliver operational fitness and market expansion strategies. After launching her career at AstraZeneca, she spent a decade at IMS Health managing key global clients.