Decentralized Clinical Trials Conducted in Community Oncology Practices May Unlock Opportunities to Address Disparities

The development of targeted therapies in oncology has shifted the notion that the best oncology care can only be provided in large academic medical centers. Exceptional hyper-local care and the availability of novel, targeted therapies have made community oncology practices innovation centers for cancer treatment. As such, there’s growing demand for these sites to offer more clinical trial opportunities for patients.

Although academic medical institutions offer ideal settings for clinical trials due to their size and resources, many patients with cancer struggle with access. Difficulties in access can be attributed to numerous factors including insurance coverage and affordability, access to precision medicine testing, longer travel times to academic institutions and more. This may lead to disparities in care and outcomes, according to Jennifer Sherak, senior vice president and president of Specialty Physician Services at AmerisourceBergen (AB), who discussed this issue in an interview with CancerNetwork®. However, the accessibility offered by community oncology practices, which are often embedded in neighborhoods and where the majority of Americans are treated for cancer, may help provide underserved populations with more opportunities to access clinical trials.¹

Sherak, whose Specialty Physician Services group at AB focuses on providing community specialty practices with access to innovative therapies, indicated that the industry has recently entered what she calls a “new era of health care” following the COVID-19 pandemic. Greater use of technology during the pandemic, especially solutions that supported digital connectivity between patients and their care teams, showed that quality care could continue in a remote environment. In addition, the pandemic put a spotlight on disparities across health care, including representation in clinical trials. All this has motivated experts across health care to question how clinical research is conducted and sparked conversations around the greater potential for decentralized clinical trials.

“Our society and the health care industry have finally and rightfully put health equity in full focus. And with today’s technology, we can finally connect and reach patients in deeper ways, and recruit for trials expeditiously,” Sherak said. “With all these factors coming together, the health care industry needs to do a better job of making sure we’re able to enroll [patients on] trials faster and include patients who truly represent the disease.”

Advantages of Trial Decentralization

Some clinical trials are only available in major cities and require substantial travel for patients. 40 percent of patients drive more than 60 minutes one way, based on research published in JAMA.² On top of this, the National Academies found that clinical research and trials need to be improved by building representation across women and under-represented groups, and research has shown that trials have disproportionately favored white male patients.^3,4

According to Sherak, another way to bring clinical trials to more patients in an equitable fashion, and offer the latest in innovative care to patients, is through decentralized trials in community settings. This could allow access to a wider and more diverse patient base, including underrepresented communities residing within rural or hard-to-reach areas that are not able to access academic cancer centers due to locality, bias or other restrictions.

“Various social determinants of health [such as] race, environment, economic, and geographical [factors] contribute to patients being disproportionately less likely to receive the care they need,” Sherak said. “It’s incredibly detrimental when you’re talking about significant illnesses like cancer. And when you think about how critical the next generation of cancer therapies will be for medicine and human race, we need trials to adequately represent the patients that will ultimately need them. It’s good science on top of being good for society.”

Aside from affording more opportunities to tap into local populations, community practices are traditionally more affordable compared with larger academic cancer centers.⁵ Although the costs are lower in the community setting, Sherak emphasized that there is no loss of support or access. Many community oncology practices can offer a full care team including pharmacists, infusion nurses, and financial counselors to help ensure optimal care including the latest novel therapies.

“There may be lower cost of care, but this in no way impacts the support and the level of innovative treatment that a patient gets in a community setting,” Sherak explained.

Creating Connections to Community Stakeholders

On Sherak’s team is Susan Weidner, senior vice president at IntrinsiQ Specialty Solutions, an organization that oversees data analytics, business intelligence, and the software development and implementation initiatives for oncology, urology, and multispecialty customers at AB. According to Weidner, bringing more trials into the community setting doesn’t come without challenges. Importantly, the infrastructure at an academic center, their access to resources and more can make conducting clinical research less challenging. Weidner explained that it’s all a matter of enabling community practices with technology that can establish a link between pharmaceutical companies’ clinical trial opportunities and these sites.

“AmerisourceBergen is looking at technologies and solutions that address the infrastructure issue, and we are looking to truly become that bridge that connects the manufacturer and their clinical study to the provider and their patients,” Weidner said. “By that connection, it helps community providers identify patients who may qualify for the clinical trial and, if it makes sense based on the providers’ expertise and clinical judgment, enroll that patient in the trial. Put simply, it creates more options for providers and their patients.”

This is also beneficial to pharmaceutical companies as the strategy also allows for more diverse patient populations that are more representative of the broader patient population. Moreover, this facilitates faster trial accrual, which is critical for pharmaceutical companies. In fact, pharmaceutical companies could lose between $600,000 to $8 million per day when trials are delayed.⁶

Other solutions to the challenges that community oncology practices face include the creation of a research network specific to community practices. It is important to unite the thousands of community practices across the United States to help bolster the clinical trial recruitment process. By unifying practices across the country and focusing efforts on recruitment, this will help to make clinical trials more available in areas with limited resources that are lacking large academic centers. The network could also work to embed technology into these practices and establish connections between pharmaceutical companies and clinical trials. Collaboration is becoming more common place across the health care sectors for a greater focus on optimal innovation and solutions.

“Community practices are poised to know local resources and are near the patient. You’re not losing that continuity of care. It’s just critical that we start local and make sure we’re supporting our local community centers with the tools and technologies to make sure that they can participate in clinical trials. All of this comes together to address cancer care disparities, poor accrual for clinical trials, and [ensure that all] patients have access to the most innovative therapies,” Weidner concluded.

References

1. Community Oncology Alliance. Accessed November 16, 2022. http://bit.ly/3UZ5ZoO
2. Galsky MD, Stensland KD, McBride RB, et al. Geographic accessibility to clinical trials for advanced cancer in the United States. JAMA Intern Med. 2015;175(2):293-295. doi:10.1001/jamainternmed.2014.6300
3. National Academic: Sciences, Engineering, Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. 2022. Accessed November 16, 2022. http://bit.ly/3Gli5En
4. Nazha B, Mishra M, Pentz R, et al. Enrollment of racial minorities in clinical trials: old problem assumes new urgency in the age of immunotherapy. Am Soc Clin Oncol Edu. 2019;39:3-10. doi:10.1200/EDBK_100021
5. Gordon L. Community Oncology Alliance. Care Cost Analysis. Accessed November 16, 2022. http://bit.ly/3V45km6
6. MD Group. The True Cost Of Patient Drop-outs In Clinical Trials. October 1, 2020. Accessed November 16, 2022. http://bit.ly/3UJ614e