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The Key to Increasing Diversity in Decentralized Trials

Historically, decentralized clinical trials (DCTs) were heralded as the future of patient-centered research. But how can your organization “walk the walk” when it comes to increasing trial access to underserved populations and enrolling diverse participants? Rosamund Round, VP of Parexel’s Patient Innovation Center and DCTs, dedicated her career to investigating and achieving just that. A recent panelist in the Advarra Symposium Adapting, Adopting, and Succeeding in a Decentralized Landscape, Round shared real DCT patient feedback and experiences. Additionally, she discussed success strategies to optimize your organization’s DCTs in improving research access for underrepresented communities.

Deploying DCTs to Improve Trial Access

Decentralized trials – those extending participation beyond the exclusive presence at a physical research site – increase research opportunities for those who live far away from sites, may not have the means to participate in a trial, or perhaps have other practical barriers to participation.

Deployment of decentralized activities do not need to be extensive or exhaustive to positively impact participants. Through ongoing discussions with patients from different racial and ethnic groups typically underrepresented in research, Round has learned of countless examples of how home or community-based participation options have supported their trial journey and experience.

For example, for some patients, a choice must be made between working to provide financially for the family or having time to join an oncology clinical trial. Home care options and extended site hours can enable such patients to participate alongside fulfilling the requirements of their daily lives.

Faced with fears of discrimination and sometimes violence, transgender and non-binary participants have also shared that visits achieved at home can create a safe and affirming space for care. “Providing alternative options for participation really opens the availability of research and supports the feeling that research is a place for everyone,” says Round.

Addressing Assumptions and Challenges in Deploying DCT Strategies

With careful attention to participant feedback, Round and her teams continue to learn and adapt to decentralized modalities as needed to accommodate varying needs and challenges. While incorporating virtual or home visits into a study may remove barriers such as transportation costs and time, it could reveal new challenges, like consistent access to Wi-Fi and digital devices. Solutions to these challenges could include providing devices with data plans to support participants – but some challenges need even more creative solutions.

“In certain areas where we’ve deployed DCTs globally, some participants felt nervous keeping an expensive device in their home. As a result, they preferred to store the device at the site, and travel to and from to log information and attend virtual visits,” said Round. “It was unexpected! And revealed that tactic wasn’t ultimately easier for all participants.”

Additionally, it’s important not to assume what each participant will prefer. “Some told us that due to COVID-19 risk or numerous other reasons they didn’t feel comfortable with nursing or other staff in their home,” reported Round. “It’s a reminder that DCTs are not one size fits all. Tactics should be adjusted for each study and incorporate a variety of participant options to best serve the patients.”

Expanding the Definition of Decentralized Trials

Across her extensive career, Round observed deploying and testing various decentralized modalities. However, the COVID-19 pandemic put on full display the clinical research industry’s ability to adapt and better serve its participants.

“One of the physicians we’ve worked with expressed early skepticism about telehealth. But after practicing virtual visits and having the opportunity to connect with patients in new ways, whether on-screen or in-person, they’ve had such a positive experience that they are now major advocates for the approach and foresee it continuing far beyond the pandemic,” said Round. “From what we’ve learned, we’ve begun to expand our idea of care options, extending beyond just the site and home to include local pharmacies and community spaces. Thanks to implementing varying types of decentralized modalities, people are truly beginning to see research as a care option.”

Decentralized trials do not have to be implemented in an exhaustive or even advanced manner to be effective. While there is a perception of decentralized trials as cutting-edge and 100% virtual, the hybrid approach is far more common, and these studies are being implemented and customized in ways that work best for the participant. Round’s main takeaway? Provide options to your participants, even if it’s as simple as minimizing how many site visits are necessary in person.

Whether your organization is new to conducting DCTs, or currently navigating the decentralized landscape, ensure your approach supports varying levels of decentralization and participation. If you would like to hear more patient experiences from Rosamund Round or explore additional strategies to successfully adopt and conduct DCTs from leaders across the industry, watch our recorded symposium today.

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