AmerisourceBergen has launched Clinical Trial Navigator, a suite of solutions designed to help clinical trials recruit with the help of community-based specialty. Specifically, it unites oncology practices and patients with trial opportunities through advanced site selection, patient identification, and enrolment tools.
Carol Riley, practice administrator with St. Louis Cancer Care, commented, “Clinical trials present the opportunity for patients to access cutting-edge therapies and offer hope for patients who may have exhausted all available treatment options; however, there have been limits to accessing this research for patients at my community-based practice. Programs that enhance and streamline recruitment efforts for community practices are much needed, and having the ability to connect more patients with active trials will be a huge win.”
To find out about Clinical Trial Navigator, Outsourcing-Pharma connected with Jenny Sherak, senior vice president and president of specialty physician services with AmeriSourceBergen.
OSP: Could you please share your perspective on disparities in healthcare, and how attitudes and awareness in the clinical research field have evolved in recent years?
JS: There’s no denying that segments of the U.S. population—based on a range of social, racial and ethnic, environmental, economic, and geographic factors—are disproportionately less likely to receive the recommended standard of care for cancer and other complex diseases. In particular, the landmark study published in 2002 by the Institute of Medicine served as a wake-up call for the industry, and the onset of the COVID-19 pandemic renewed the urgency to make progress on closing gaps in care sooner rather than later.
At AmerisourceBergen, we believe breaking down barriers and addressing inequities to ensure everyone has access to quality care and advanced therapies should start in the community setting with a collaborative approach across the healthcare system. Not to mention, as the drug development pipeline evolves where therapies will be targeted to smaller, defined patient populations, it’s critical to involve community specialty practices in order to identify these patients and match them with appropriate clinical studies.
AmerisourceBergen has begun to roll out tools and innovative digital health solutions—one of them being Clinical Trial Navigator, a solution platform that connects community-based specialty physician practices and their patients with an increased number of clinical research opportunities.
More and more, manufacturers and healthcare providers are actively seeking out resources and tapping key stakeholders to help facilitate more accessible and inclusive clinical trials. For example, Biogen made a commitment to enroll a diverse population in the Phase IV trial for its Alzheimer’s drug Aduhelm.
Moreover, the Biden administration has been clear that advancing health equity among racially marginalized groups is central to its healthcare policy decision-making, whether related to the administration’s pandemic response or the reignited Cancer Moonshot initiative. The Centers for Medicare & Medicaid Services (CMS) and payers have shifted priorities in recent years to address social determinants of health, even identifying a range of efforts to encourage and sustain providers’ work in reducing disparities. Also, CMS, through its Center for Medicare & Medicaid Innovation (CMMI), announced the launch of the Enhancing Oncology Model (EOM) with a major focus on advancing health equity for cancer patients.
Twenty years removed from that landmark study and two-plus years into the pandemic, the collaboration and prioritization across the healthcare industry, especially those stakeholders working within clinical research, is very encouraging.
OSP: What are some of the approaches professionals in clinical research and drug development have taken? Please feel free to discuss which have been more successful than others and which have maybe fallen short.
JS: A report from the National Academies found recruiting for trials has fallen short—chiefly due to the fact that recruiting has not been an inclusive or representative process in many, if not most, research opportunities. And, unfortunately, clinical trials have disproportionately favored white, male patients.
A lot of work needs to be done to find trial enrollees that truly represent the individuals most affected by a particular disease, not only to support access but to bolster the science. Contributing to the disproportionate participation is often the lack of trial availability beyond large, academic medical institutions in major metropolitan areas and restrictive eligibility criteria, medical mistrust, and stigma associated with clinical research.
As I shared, AmerisourceBergen wholeheartedly believes that addressing health disparities starts in the community setting while working collaboratively across industry stakeholders, including pharmaceutical companies, lab companies, payers, patient advocacy groups, and our independent practice customers. We view community oncology practices as essential to achieving health equity because they’re already ingrained in their communities, and the majority of patients with cancer are treated in this setting.
Yet, very few are enrolled in clinical studies. This was the impetus behind Clinical Trial Navigator. Through this platform, biopharmaceutical companies can set study enrollment criteria to identify relevant practice sites and their ideal patient populations, streamlining the patient recruitment process and expanding the applicant pool significantly.
Additionally, we’re currently in beta testing for our Precision Medicine Exchange. This digital health solution aims to improve the treatment selection process given their molecular profile for the patient’s condition. Through the process, providers will be able to understand how other similar patients have been treated, what available treatments exist, and when there are none, available clinical trial opportunities for the given patient. We’re excited about this solution’s potential to strengthen the path forward for the development and adoption of targeted therapies.
OSP: How has the pandemic impacted care and research disparities?
JS: We’ve kept a close eye on how the COVID-19 pandemic has impacted care and research, and, as I mentioned previously, it’s brought disparities in cases and outcomes to the forefront. An issue, which directly impacts research recruitment efforts, is the disproportionate effect COVID-19 has had on people of color, especially Black and Brown communities. Individuals from racially marginalized groups are at a higher risk for severe outcomes and comorbid COVID-19.
And, as we know, eligibility criteria for research opportunities often inadvertently exclude participants with comorbidities. That has implications for clinical-stage therapies, which once approved, will be used among a broader patient population. So many questions arise, but the main one being: Will a patient with coexisting health conditions respond well to this treatment? It's critical that research doesn’t exclude comorbid individuals if we really want to make progress on advancing health equity and avoid poorly targeted treatment.
OSP: Specifically, how has cancer care and research been impacted? Have disparities in cancer been affected in different ways than in other therapeutic areas?
JS: A figure that I’m sure many people saw circulating throughout the pandemic: nearly 10 million missed screenings for just about every form of cancer. I will add that screening rates rebounded in the fall of 2020; however, oncologists are worried that screenings haven’t returned to pre-pandemic levels for everyone.
For example, from September to December 2020, fewer Black and Hispanic women received a mammogram than in the three months prior to the pandemic. Another alarming stat: Black men were 25% less likely than their white counterparts to have a prostatectomy during the pandemic. Those are scary statistics that could have major repercussions.
When you think about patients missing screenings during COVID-19 and getting to cancer treatments later in the disease progression, it’s a serious problem. And then if you compound that serious issue with healthcare access barriers or social determinants that many of these patients already have, it’s anticipated that long-term health outcomes will decline.
And, of course, the pandemic paused, slowed, or caused withdrawals in clinical trials, which has a ripple effect on the research of new drugs and, ultimately, patient care. Clinical trials offer access to some of the most advanced therapies that aren’t widely available yet. And, when clinical trials were terminated or drawn out, patients with cancer suddenly didn’t have access to a promising therapeutic. Two years removed from March of 2020, oncology clinical trials have rebounded, but the brunt of the initial months of the pandemic is yet to be fully realized.
OSP: Please discuss how you and your colleagues at AmerisourceBergen have been working to address these issues.
JS: At AmerisourceBergen, we launched a Disparities in Cancer Care Task Force that’s hyper-focused on addressing disparities and analyzing social determinants of health for patients at the local level. That Task Force has a detailed road map, which includes:
- conducting research and publishing studies on health disparities in partnership with our provider customers and industry stakeholders
- creating solutions to enhance access to precision medicine testing and research, like the recently launched Clinical Trial Navigator platform
- finding ways to help bring precision medicine to patients; leveraging our relationships with healthcare stakeholders, like pharmaceutical manufacturers, payers, and more, to engage them in discussions about social determinants of health at the community level, and advocating at the federal level to improve the lives of patients affected by complex diseases.
All of us at AmerisourceBergen are very excited by the recent innovations and developments we’re introducing to the market, helping to bring more clinical trials into communities nationwide and generate more equitable and accessible trial opportunities for underrepresented groups.
OSP: Do you have anything to add?
JS: I firmly believe that if we continue to coordinate, collaborate, and have a consistent focus on ensuring equitable access to quality care we will make progress in closing gaps and breaking down barriers. How much progress is made in however much time will depend not only on scientific and medical innovation but also on intentional inclusion and representation.