Committing to enrolling a sufficiently diverse set of patients for a clinical study is only part of the battle. Finding and enrolling those patients is another obstacle trial teams frequently need to overcome to meet their inclusivity goals.
Outsourcing-Pharma recently connected with two leaders from Eversana to discuss what makes reaching and enrolling these special patients so difficult, as well as solutions that can make the work less of a struggle:
- Elizabeth Katta, engagement manager for Seeker Health by Eversana.
- Brigham Hyde, president of data and analytics with Eversana
OSP: What are some of the reasons why trials fail to attract and retain sufficiently diverse patient populations—despite the commitment of professionals at various levels to make improvements?
EK: Broad efforts have been implemented to increase diversity in clinical trials, but disparities remain largely due to misaligned strategies from stakeholders. There are several barriers that remain that as an industry we must continue to work to overcome.
First are systemic barriers. There continues to be widespread medical mistrust due to the historic exploitation of clinical trial information. This comes primarily from a lack of appropriate education to drive trial awareness or make decisions to participate.
Many patient populations may be perceived as not wanting to participate in trials and therefore are not asked, which limits the true diversity that should be reflected in more trials.
A second barrier we commonly see is culture.
Both language barriers, with many trials still only held in a single or few languages, limit broader participation. Additionally, some religious beliefs may not fully embrace the concept of clinical trials, which can lead to limited participation from some cultural groups. And finally, a lack of representation in trial population and a lack of resources, especially staff – to effectively help communicate to some cultures and what it means to participate - can be challenging.
And a final barrier we often see impacting participation in clinical trials is logistical. Many trials today still lack adequate funding for participants or honoraria, making the time commitment for participants not worth missing work for potentially days or weeks. Additionally, as many trials are held at larger regional medical centers, transportation to these can be challenging, especially depending on the target audience.
Many clinical trial programs are working on how to address these and other challenges, but we must continue to find ways to break down barriers and open access to more participants. And digital technology is one way we’re able to help spread the word about trials through platforms like Seeker Health by Eversana.
OSP: Specifically, could you please share some of the challenges associated with data collection and analytics in clinical trials relating to diverse patient populations?
EK: Challenges leading to a lack of appropriate data collection diminish the ability to researchers to perform analyses demonstrating efficacy in needed populations. Some of these challenges can include a narrow eligibility criterion, failure of the trial collection to report critical demographic data like participant gender or race, and finally, failure to include vulnerable populations including those who are cognitively impaired, have several co-morbidities, are elderly, and pregnant women continue to be challenging.
OSP: Please talk about some of the ways in which technological tools can help make a difference.
EK: Technologies can help immediately reduce logistic and travel barriers as well as elevate participation and its impact on marginalized populations in real-time. Here are some newer, more modern innovations we have seen that continue to make a difference.
- Wearable and telehealth technologies can help individuals not close to a trial site participate. These solutions have advanced immensely over the past decade and will continue to be part of the strategy to bring more participants to clinical trials.
- Technologies leveraging real-world data (RWD) can help sponsors and their partners understand where to establish trial sites and recruitment efforts based on diverse patient needs.
- Digital content can increase awareness and education to meet diverse populations where they are. We live in a digital age, and through new platforms, we can bring people to forums and other digital hubs to be actively involved as if they were in a facility in many ways.
- And finally, social media can increase awareness and education efforts as well as highlight real-time participation to normalize conversations about trial participation and increase buy-in. This is where Seeker Health got its start, and we continue to see more patients going to these platforms looking for support groups for questions and answers among peers, clinicians, and others.
OSP: Could you please tell us some of the ways in which your company is poised to help study professionals attract more diverse patient groups in their trials? Please feel free to mention specific technology offerings
EK: One of Eversana’s cultural beliefs is to embrace diversity- and we strive to help our sponsors increase health equity by attracting diverse patient groups to clinical trials.
Seeker Health by Eversana exemplifies this belief by leveraging digital advertising to meet patients where they are. Advertising can be tailored for demographics and psychographic specifications so sponsors can meet their recruitment targets with the populations most reflective of the drug’s intended use.
OSP: Could you tell us about your most recent partnership using your ACTICS platform, and how it might help?
BH: In the evolving world of RWD, registries, and clinical trials, it has become increasingly likely that a patient could end up participating in all three through the course of their care journey.
This raises the question of how to think about this journey holistically and maximize the research value that can be created by thinking of these three mediums along a single continuum. In addition, at the backbone of this convergence are the concepts of consent, identity management, and research ethics.
Our recent partnership with Thread brings together three platforms – Eversana’s RWD platform, Datavant’s de-identification technology, and Thread’s decentralized trial platform, to ensure we now safely and securely manage and connect these patients through those various mediums.
The result of this is a convergence of prospective data collection with the combination of retrospective observational research. We can combine the active collection of things like ePRO eCOA, and other instruments, with the integration of EMR and Claims data, which will allow for a dataset that can enable multiple analysis types from a single study effort.
It reduces the burden of data collection, while also keeping consent and identity management at the center of the process, putting the patient in charge of how their information is managed. The end result: we believe will be research and evidence acceleration throughout the lifecycle, leading to better cures for patients and increased evidence for care.