Interview About Decentralized Oncology Trials with Devon Adams, Senior Analyst at the ACS CAN

The American Cancer Society Cancer Action Network (ACS CAN) makes cancer a major priority for public officials and candidates at the local, state and federal levels.

The goal of the ACS CAN is to “empower advocates across the country to make their voices heard and influence evidence-based public policy change as well as legislative and regulatory solutions that will reduce the cancer burden.”

One of these cancer advocates is Devon Adams, an ACS CAN staff member with diverse policy and clinical experience. Adams is a Senior Analyst for Policy and Legislative Support – Emerging Science at the ACS CAN.

Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more!

Can you tell us about the work you have done on the topic of decentralized clinical trials (DCTs) as a Senior Analyst for Policy and Legislative Support at the ACS CAN?

Adams: We know from research that logistical challenges such as travel time and distance to a trial site are often a barrier to patient enrollment in clinical trials. Decentralization of trials can alleviate travel burden associated with trial participation by delinking where a patient is evaluated and treated in respect to a trial and where a trial is hosted.

Last year, we sought to understand the association between remote technology and other decentralization tools with patients’ likelihood to enroll in a cancer clinical trial. We developed a survey with a series of questions related to telehealth, remote care technologies and willingness to participate in cancer clinical trials. Over 1,100 cancer patients and cancer survivors responded. We found that the use of remote technology and other decentralization tools that can decrease the need for travel to a trial site was associated with an increase in self-reported patient likelihood toward participation in cancer trials. The study findings were published in JAMA Network Open in July 2022.

We have also been advocating for provisions included in proposed bills that would require the Department of Health and Human Services to issue guidance on how to conduct DCTs to improve demographic diversity.

How does the ACS CAN help improve access to clinical trials, including patients from minority and socioeconomically disadvantaged groups, patients with disabilities and patients who live in rural areas?

All cancer patients — regardless of their economic means, race/ethnicity, or their geographic location — should have a chance to enroll in clinical trials. ACS CAN has worked with the bill sponsor on developing and advocating for the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, which could increase diversity in clinical trials and make it easier for all people with cancer to participate in clinical trials by reducing socioeconomic and geographic barriers to enrollment.

This bill would create a statutory safe harbor to allow sponsors to provide patients with financial support for the non-medical costs associated with their clinical trial participation, allow trial sponsors to provide patients with technology necessary to facilitate remote participation in clinical trials, and require the Department of Health and Human Services to issue guidance on how to conduct DCTs to improve demographic diversity.

Do you think DCTs can help ensure more patients — regardless of ethnicity, race, economic means, geographic location — have an opportunity to enroll in clinical trials? Why or why not?

Over half of cancer patients who are offered a clinical trial agree to participate regardless of race or ethnicity. This fact challenges the common myth that patient decision making is the primary barrier to participation in trials. We also know that over three-quarters of patients will not have a local trial available for their cancer.

Without easy access to trials, patients often need to travel long distances to participate in an available trail. When you factor in travel costs, such transportation and lodging you can easily see how this could preclude patients with lower incomes from participating in trials. Adoption of tools to facilitate DCTs can alleviate patient barriers such as no local trial availability and increased travel and costs, to ensure more patients have the option to enroll in trials.

In your opinion, what are the biggest challenges in adopting DCTs/virtual practices in oncology clinical trials?

One of the biggest challenges will be digital access, including access to remote technologies, broadband and digital health literacy. We will need to make sure we don’t create new disparities based on access or comfort with technology. The DIVERSE Trials Act contains a provision to allow trial sponsors to provide patients with the technology necessary to facilitate remote participation in clinical trials which would be particularly helpful in addressing this challenge.

What are some examples of DCT approaches you have seen that may greatly alleviate the patient burden in oncology clinical trials?

The COVID-19 pandemic and subsequent regulatory guidance from the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI) on the conduct of clinical trials increased the adoption of DCTs. Many trials adopted approaches such as virtual clinic visits, use of remote consent, delivery of investigational products to the home and use of alternative laboratories or imaging centers which allowed trials to continue during the pandemic. Our research shows that when these approaches can reduce participation-related time and travel it is associated with an increase in self-reported patient likelihood toward participation in cancer trials.

Is the ACS CAN working with sponsors/industry to help improve patient recruitment and retention in oncology clinical trials? Are there any examples of work being done with sponsors/industry to improve the adoption of DCT approaches in oncology trials?

Matching patients with trials requires a challenging amount of manual entry and/or manual review of trials and frequently this is not integrated into existing clinical workflows. As a result, patients eligible to participate in a clinical trial may not be identified or asked to enroll. Also, many patients do not have a local trial available for their cancer at the institution where they are being seen, and providers do not have means to easily identify trials for their patients that are conducted outside the treating healthcare institution.

ACS CAN is working with several partners to develop interoperable clinical trial matching services. The initiative, known as “Blue-button” trial matching would make clinical trial matching accessible to all patients and providers at the point of care. Our approach is to develop open data standards and open APIs that enable interoperable, scalable and accessible clinical trial matching services that are integrated into existing clinical workflows. Ultimately, the goal is to ensure opportunities for patients to consider clinical trial participation regardless of where they are initially treated and to identify a larger pool of patients eligible to participate in trials.