ACORI Research Review: June 2024

Each June, we celebrate National Cancer Survivor Month in honor of every individual who has faced cancer in his or her lifetime. As of 2022, approximately 18.1 million individuals in the US are cancer survivors, accounting for just over 5% of the population.¹ A person is considered a cancer survivor if they have been diagnosed with cancer at any point during their life, including those who are newly diagnosed, actively undergoing treatment, or in remission.² Thus, the scope of survivorship varies greatly depending on what stage of the cancer journey a patient is currently facing. Throughout the years, the number of cancer survivors in the US has gradually increased, from about 3 million in 1971 to 9.8 million in 2001.³ By 2040, it is estimated that the number of survivors will reach 26 million.¹

Today, most survivors (69%) have lived at least 5 years since their diagnosis and 18% have reached the 20-year mark and beyond. Among current survivors, the most common cancers have been female breast (4.1 million), prostate (3.5 million), melanoma (1.5 million), colorectal (1.4 million), and gynecologic malignancies (1.4 million). As cancer survivors grow in number and age—it is thought that three-quarters of US survivors will be 65 or older by 2040—it is imperative that we understand the unique challenges and complexities of care related to survivorship. Cancer survivorship research helps to characterize long-term toxicities and optimize psychosocial well-being and overall health after cancer treatment.⁴

Many cancer treatments carry significant risks of long-term or late complications such as cardiac impairment, sexual dysfunction, infertility, early menopause, chronic fatigue, chronic pain, compromised immunity, neurocognitive decline, secondary malignancies, and more. Clinical outcomes aside, psychosocial health and financial toxicity are also critical areas of focus for cancer survivorship. Survivorship research can generally be considered to fall into five main buckets: epidemiology and surveillance, symptom management, psychosocial research, health care delivery, and health behaviors.⁵ From a broader perspective, health equity remains an important area of opportunity for survivorship research. The American Cancer Society estimates that a quarter of the ~600,000 annual cancer deaths in the US could be prevented with equitable access to cancer prevention, screening, and treatment.⁶

Survivorship research in the context of health equity has been expanding for the last several years, with approximately 20% of the NIH Cancer Survivorship Grant Portfolio from 2017 to 2022 dedicated to health disparities. Most grants were focused on survivors from racial and ethnic minority groups (74%), followed by survivors in underserved geographically rural areas (26%), and those experiencing socioeconomic disadvantages (25%). Sixty-five percent of the grants “measured or intervened on drivers of health disparities on a level of influence beyond the individual”, which indicates a concerted effort toward understanding how societal, institutional, and social factors play into health inequities.⁷ However, there is still a lot of work to be done. Future research that incorporates collaboration between multiple service sectors (i.e., commerce, housing, food systems, etc.) and community organizations may be a promising way to improve health disparities among cancer survivors.

In honor of National Cancer Survivor Month, the American Association for Cancer Research (AACR) provides a variety of ways for clinicians, patients, and the general public to support cancer survivors and promote cancer survivorship research. Individuals can contact their congressional representatives about prioritizing cancer research, share about National Cancer Survivor Month on social media, donate to AACR (or other) cancer research efforts, become a patient advocate, or learn more about cancer progress in the US.⁸ Cancer survivorship affects all of us in one way or another; the better we can support survivors, the stronger we will be as a society. While we honor our survivors every day, let us take an extra moment this month to reflect on the survivorship journey for all those we know and do not know.

References

1. National Cancer Institute - Division of Cancer Control and Population Sciences. Statistics and Graphs. Updated May 2, 2024. Accessed May 23, 2024.
2. National Cancer Institute. Cancer Survivorship. Accessed May 23, 2024.
3. Cancer Survivorship --- United States, 1971—2001. MMWR. 2004;53(24):526-529. Accessed May 23, 2024.
4. Aziz NM. Cancer survivorship research: challenge and opportunity. The Journal of Nutrition. 2002;132(11):3494S-3503S.
5. Mollica MA, Smith AW, Tonorezos E, et al. Survivorship for individuals living with advanced and metastatic cancers: national cancer institute meeting report. J Natl Cancer Inst. 2022;114(4):489-495.
6. Yabroff KR, Gansler T, Wender RC, Cullen KJ, Brawley OW. Minimizing the burden of cancer in the United States: Goals for a high‐performing health care system. CA A Cancer J Clinicians. 2019;69(3):166-183.
7. Doose M, Mollica MA, Acevedo AM, et al. Advancing health equity in cancer survivorship research: National Institutes of Health 2017–2022 portfolio review. JNCI: Journal of the National Cancer Institute. Published online March 27, 2024.
8. American Association for Cancer Research (AACR). AACR Cancer Progress Report. Accessed May 23, 2024.

The 50th Annual ACCC Meeting and Cancer Center Business Summit took place this past winter from February 28 – March 1 in Washington, DC to navigate trends in business, technology, and policy in the ever-changing cancer care landscape. Several annual awards are presented at each conference to honor individuals who have made a profound impact on patient care, clinical research, and the greater oncology community. This year’s recipient of the 2024 Clinical Research Award, which recognizes those whose research has “significantly and positively impacted the oncology patient, family, and/or community,” is the distinguished Dr. Robert A. Winn, Director and Lipman Chair in Oncology at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center, Senior Associate Dean for Cancer Innovation and Professor of Pulmonary Disease and Critical Care Medicine at VCU School of Medicine.

Dr. Winn attended the University of Michigan Medical School in Ann Arbor and completed his residency training at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, followed by a fellowship in pulmonary and critical care medicine at the University of Colorado Health Sciences Center in Denver. His background in pulmonary medicine inspired him to focus his research efforts on understanding the molecular pathways of lung tumorigenesis and investigating novel approaches to treatment.

In addition to his numerous contributions to translational lung cancer research, Dr. Winn has also dedicated his career to improving care in underserved communities and eliminating health disparities. As a young trainee, he realized that new advancements in medicine were not reaching everyone equally; it was primarily benefiting White, wealthy, and urban folks with the knowledge and means to participate in trials. In the words of Dr. Winn, “if people can’t get to your bedside, they’re not getting any benefit from the research that you’re doing at the bench side.” Dr. Winn understood early on in his career that for his—or anyone’s—basic science research to have a real impact, the health system needed to be fixed so that every patient could have equitable access to care.

Since becoming director of the Massey in 2019, Dr. Winn has made it a priority to get to know the communities his cancer center serves. Throughout the year, Dr. Winn visits neighborhoods in surrounding Richmondthat are low-income, rural, or comprised of ethnic minorities to learn about the realities of these underserved populations and build relationships with members of these communities. These “district walks,” as he calls them, have inspired him to pursue out-of-the-box ways to address disparities by becoming involved with housing development projects, grants for community projects, policy change, and various community organization initiatives.

One example of community partnership is the Facts & Faith Fridays initiative, a monthly conversation with the African American faith-based community that was launched during the COVID-19 pandemic by Dr. Winn, Reverend F. Todd Gray of Fifth Street Baptist Church, and Rudene Mercer Haynes, a Massey Advisory Board member. The founding members recognized the influence of faith leaders in the African American community and leveraged their authority as trusted sources of information to reach this important population with accurate information during a time of critical need. These days, the Facts & Faith Fridays event has expanded its focus to highlight a variety of topics such as cancer risks and prevention, systemic racism and health inequity, medical myths and mistrust, and health resources in urban and rural communities. This innovative initiative provides a strong example of working with non-medical community leaders to empower traditionally marginalized populations. In 2020, the Bristol Myers Squibb Foundation established the Robert A. Winn Diversity in Clinical Trials Award Program to address health inequities in clinical research. The program, named in honor of Dr. Winn for his extensive work in cancer disparities, will support hundreds of clinical investigators and medical students who are committed to advancing diversity in clinical trials and improving health outcomes in all populations.

There are three primary tracks in the Winn Award Program: the Winn Career Development Award (CDA), the Winn Clinical Investigator Pathway Program (CIPP), and the Winn CDA Scholars in Oncology (CILA). The Winn CDA is a 2-year program for early-stage physician investigators that provides a community-oriented research curriculum and mentorship. The Winn CIPP offers a summer externship in which underrepresented medical students have the opportunity to work in community-based research organizations and learn the basics of clinical trials. For graduates of the Winn CDA, a 3-year career and leadership award is available in the form of the Winn CILA. Inspired by Dr. Winn, the goal of the Winn Award Program is to shape the next generation of trial investigators to bridge the gap between clinical research and underrepresented communities. During his long-standing commitment to improving health inequities in cancer care, Dr. Winn has exemplified excellence in clinical research and community action as he continues to lead the oncology community towards a more inclusive future.

The second award bestowed this year was the David King Community Clinical Specialist Award, named in honor of ACCC Past President (1988 – 1989), Dr. David K. King, MD, FACP, a community oncologist who advocated fiercely for clinical research in the community setting. The David King Award recognizes individuals who have “demonstrated leadership in the development, participation, and evaluation of clinical studies and/or are active in the development of new screening, risk assessment, treatment, or supportive care programs for cancer patients.” This year, the award goes to Christa Braun-Inglis, DNP, APRN, FNP-BC, AOCNP, a nurse practitioner and assistant researcher at the University of Hawai’i Cancer Center and clinical faculty member at the University of Hawai’i Nancy Atmospera-Walch School of Nursing.

Dr. Braun-Inglis received her nursing degree from the University of Hawai’i in 1994, where she eventually returned for her master’s and doctorate degrees. After becoming a nurse practitioner, she started practicing at an oncology clinic in California, where she met Dr. Randall A. Oyer (ACCC Past President), who—alongside other physician and nurse practitioner colleagues—empowered her to maximize her potential as a nurse practitioner and practice at the top of her license.

Armed with an emboldened perspective, she returned to Hawai’i to practice as the only advanced oncology certified nurse practitioner in the state at the time. Over time, Braun-Inglis learned about integrating clinical research into her community oncology practice as she would see patients and empower them to enroll in ongoing clinical trials that were a good fit for their clinical picture. In 2018, Braun-Inglis transitioned into a part-time clinical and part-time research-focused faculty role. At the time, clinical research was significantly underutilized by advanced practice providers in Hawai’i. This reflected national policies and attitudes that were not conducive to advanced practice providers (APPs) participating in research. Since becoming involved in research herself, Braun-Inglis has dedicated much of her career to expanding advanced provider roles in clinical research.

In 2020, Braun-Inglis conducted a survey through ACCC and Harborside Press to delineate practice patterns and perspectives of oncology APPs in clinical research. Among 408 respondents, 62% reported practicing in the community setting and 70.6% were nurse practitioners. Eighty percent of respondents routinely participated in the care of patients enrolled in clinical trials and 70% were involved in identifying, recruiting, and coordinating patients for trials. Only 15% reported being an enrolling provider for patients, and only 10% served as principal investigator (PI) for at least one study. In terms of APP beliefs, 62% were comfortable discussing the available clinical trials at their sites with patients; 37% usually or always explored potential study options for each patient; and 21% regularly approached potentially eligible patients about trials. Overall, nearly 75% of respondents indicated that they were interested in becoming more involved in the clinical trials process.

Braun-Inglis’ analysis revealed that there are many opportunities for APPs to become more involved with clinical research. Given their strong clinical presence throughout a patient’s treatment journey, APPs are uniquely positioned to enhance study accrual and manage patients on trial. Advanced practice providers are experts in symptom management, care coordination, and survivorship—all skills that are critical to conducting a clinical study. To overlook these potential contributions would lead to a substantial missed opportunity for clinical research stakeholders. According to Braun-Inglis, “if you’re going to hold the APP back, it’s going to slow down your research because we are so integrated in everyday clinical practice now. If you’re not engaging us, educating us, and allowing us to do clinical research, it’s a huge barrier for the success of your research protocol.”

To further support APPs in research, it is important for institutions to provide more education and mentorship around clinical trials and designate research-based activities for APPs. Most recently, Braun-Inglis has been working with the NCI/NCI Community Oncology Research Program (NCORP) on a project evaluating APPs engagement in oncology trials that examines workflows, develops resources, and provides education to bolster engagement. She recently completed a mentorship project to assess whether a strategy of formal APP mentorship and paired clinical research associate support can increase accrual for supportive care trials within the Hawai’i Minority Underserved NCORP. As a result of these efforts, the amount of trial accruals, APPs actively enrolling patients, APPs serving as site PIs, and APPs reviewing trials have all increased. She is now working to expand this concept throughout the NCORP at the national level.

Braun-Inglis’ strong advocacy and research efforts embody the spirit of the David King Award as she continues to pave the way for advanced practitioners to demonstrate their value and potential in clinical research.

During the height of the COVID-19 pandemic, numerous strategies were implemented by the FDA and the NCI to maintain clinical trial operations while reducing in-person visits. These included the use of electronic consent forms, telehealth visits, direct drug shipments to patients, remote monitoring, and more. One of the notable positive outcomes associated with these adaptations was the increase in number of patients from rural communities who enrolled in clinical trials during this time. To further assess the impact of the COVID-19 regulatory changes on clinical trial enrollment, the Rural Health Sub-Committee (RHSC) of the Alliance Clinical Trials Network Community Oncology Committee conducted a survey in 2021 asking questions such as “What is the level of impact the NCI process changes has had on your site with regard to enrollment of patients into trials?” and “What are the key drivers to rural clinical trial participation in your practice?”

Thirty-three members responded to the survey, of which 73% reported an increase in rural patient enrollment compared to pre-COVID times. Remote consent (44%) and visit requirement adaptations (37%) had the greatest impact on clinical trial enrollment. However, remote consent was also noted to be the process change that most increased clinic burden. In general, respondents felt that small sites were disproportionately burdened to adapt telehealth measures. Lack of computer hardware, low staff knowledge about technology platforms, lack of clinic space, and limited staffing availability to engage in remote operations were all identified as barriers to using telehealth in clinical settings. Patient-related barriers to trial participation included time and distance necessary to participate, concerns about treatments being tested, amount of burden on caregivers, and lack of reliable broadband connectivity. Survey respondents indicated that the greatest facilitators of rural enrollments for sites consisted of having an active community outreach plan and adequate infrastructure (i.e., staffing, electronic medical record systems, space) to support trials.

In response to the survey results, the RHSC created a conceptual checklist to help sites enhance enrollment of rural patients during all stages of a trial, including trial design, community outreach, and infrastructure. This checklist is intended for investigators who are designing a trial on a national level and covers the following aspects: patient characterization, imaging, consent, telehealth, financial support, care delivery, and recruitment strategies. The first step to recruiting rural patients is defining the degree of rurality in different regions and establishing enrollment goals based on these classifications. For example, a study could use the Rural Urban Continuum Code (RUCC) and set an enrollment target of at least 50% of patients residing in RUCC 4 and above areas (corresponding to populations of less than 5,000 to more than 20,000, adjacent or not adjacent to a metropolitan area). To support recruitment, sites and investigators should consider partnering with community organizations to promote trials through events and informational sessions.

When it comes to operationalizing trials, the checklist suggests various strategies to reduce the need for rural patients to travel to trial sites. Imaging burden can be potentially alleviated by partnering with rural clinics or mobile imaging units for repeat imaging, expanding the window of image eligibility, allowing the use of CT instead of PET when appropriate, and anticipating insurance coverage issues if imaging exceeds standard of care guidelines. Remote consent should be made available to all participants and sites may even consider training local health centers to assist with the consent process.

Telehealth can be used to monitor symptoms remotely, although it should be noted that remote patient monitoring is not without its own set of challenges. Enhanced technology also allows for more collaboration with local health care providers who may be able to take on roles on decentralized clinical trial platforms. Local providers can also be useful partners to administer standard of care treatments that patients do not necessarily have to receive at a trial site. Lastly, it is essential to consider financial support for rural patients when budgeting for studies. A portion of trial funds should be allocated to local or state services for transportation or accommodation coverage to reduce the stress and burden of travel.

In summary, this investigation observed that regulatory changes from the pandemic prompted unique shifts in patient enrollment patterns in clinical trials.1 More patients from rural settings were found to enroll in trials once they required fewer in-person visits. Investigators can continue to build upon these trends by utilizing the RHSC checklist to design trials with rural enrollment in mind. Only with an intentional effort to reduce the burden for these patients can we expand research access for this underrepresented community.

References

1. Stout NL, Nikcevich D, Henderson TO, et al. Improving rural clinical trial enrollment: recommendations from the rural health working group of the alliance clinical trials network. JCO. 2024;42(14):1722-1725.

While nearly all oncologists would agree that clinical research is an essential component of cancer care, the reality is that most oncology practices lack the infrastructure, resources, and time to meaningfully implement novel clinical research at their institution. But what if it were easy for every oncology provider -- regardless of practice setting -- to engage in clinical research?  What if patients could participate in clinical trials and receive cutting-edge therapies anywhere in the country? These challenges and opportunities are what inspired Dr. Mark Lee, MD, PhD and his team to found N-Power Medicine in 2021. Initially trained as a medical oncologist, Dr. Lee spent many years of his career in the pharmaceutical and diagnostic industries, where he encountered the same fundamental problem time and again: our system is not set up to enable the vast majority of cancer patients (and their data) to contribute to the development of new life-saving drugs. The existing model needs to be revamped to increase access to clinical research: as a part of every oncologist’s practice and every patient’s care.

N-Power Medicine aims to re-invent this model through a comprehensive point-of-care platform that introduces a single workflow for both routine patient care and clinical research, simultaneously. The goal is to generate research-ready data for all patients in real-time while dramatically reducing clinician workload, especially for tasks such as gathering patient data and generating clinical notes for the electronic health record (EHR). The N-Power platform is comprised of 3 core components: the Kaleido™ Registry (a point-of-care technology solution) as well as on-site and virtual experts to support clinic and research staff. But what does all of this actually mean? The best way to understand the benefits of the N-power platform is to walk through the journey of a single patient who has consented to the N-Power process in a participating clinic. N-power platform is to walk through the journey of a single patient who has consented to the N-Power process in a participating clinic.

Starting about a week prior to the patient’s appointment, the N-Power virtual team begins the process of abstracting the patient’s data from the clinic’s EHR and other data sources into the N-Power Kaleido™ Registry. Alongside the data abstraction, the N-Power team is also synthesizing the patient’s information into a pre-built note template for the provider to review and use during the appointment. (As you can imagine, this is a substantial time-saver for oncology practitioners in the clinic.) During data collection, patients are automatically identified for potential trials available at the site. These findings (including data needed or tests that must be ordered) are communicated to the clinic and research staff before the visit. When the provider eventually sees the patient, they are prepared to discuss the clinical trial with the patient. Once patients enroll onto a trial, the on-site N-Power staff function similarly to clinical research coordinators to provide support to sites in various capacities, enabling the clinic staff to focus their efforts on patient care and opening new trials.

Essentially, the N-Power model empowers providers to become more involved with research by reducing the administrative burdens of routine care, such as data gathering and documentation. N-Power also reduces the legwork involved with pre-selecting patients for trials and handling back-end research operations. In the Kaleido™ Registry, every patient becomes a potential research candidate, as the data are structured and standardized for research at every visit. The N-Power Registry thus serves as a launchpad for clinical research by elevating the data in the routine care population to bridge the gap to clinical research. Even the non-trial patient data contribute to the drug development process by helping to inform optimal trial design and realistic eligibility criteria.

Currently, N-Power is partnered with 4 community oncology sites across the country. We spoke with Dr. Barbara L. McAneny, MD, medical oncologist and CEO of New Mexico Oncology Hematology Consultants and founder of the New Mexico Cancer Center Foundation. We discussed her institution’s experience with N-Power since bringing them on board in 2021, shortly after their launch. Dr. McAneny first came across the company at a National Cancer Care Alliance (now ONCare Alliance) business oncology meeting, where stakeholders discussed barriers to leveraging oncology data and the need for cleaner data. At the same time, providers expressed frustration with trying to extrapolate clinical trial results from demographically homogenous study populations to the diverse range of patients who are actually seen in their practices: individuals from underrepresented backgrounds with multiple comorbidities, prior cancers, abnormal lab values, and other clinical idiosyncrasies.

Community-based oncologists frequently expressed the desire to have clinical research as an integral part of their practice but felt limited by inadequate resources and infrastructure. As Dr. McAneny describes, conducting research often becomes a “money-losing hobby” in the community setting. One or two providers may see a patient with a specific mutation and decide to open a trial for that type of patient, but by the time the next eligible patient comes along, many months may have passed, and it becomes inefficient and cost-prohibitive to keep these trials open under such circumstances. In these settings, it would be ideal to have a data platform to identify which types of patients (genetic mutations, etc.) are seen frequently enough in a particular clinic to statistically power a given clinical trial. Dr. McAneny has tried various new programs throughout the years to identify patients for trials, but none of them lasted long in her clinic because they created an unsustainable logistical burden for her staff. What has made N-Power a successful partner over the last few years, in her words, is how well the model has embedded itself into the daily workflow of New Mexico Cancer Center (NMCC) and alleviated administrative hurdles for the staff.

Dr. McAneny notes that the N-Power Digital Health Staff, who she refers to as “superscribes,” are especially helpful for the physicians because of their strong medical backgrounds. This fund of knowledge allows them to synthesize information in a way that is more useful than a routine scribe who is primarily transcribing speech-to-text. The “superscribe” can identify which patients have been flagged as potential candidates for a trial, review the chart to see if the patient is eligible, and prompt the provider to collect more information or discuss the trial with the patient. For patients enrolled in trials, the N-Power clinical trial staff have also been an asset: Dr. McAneny’s research staff essentially see the N-Power team as an extension of their own team. The N-Power system was first implemented for one physician in the practice, and after that provider was comfortable with the process, it was rolled out to others. Currently, all medical oncologists actively seeing patients at the Albuquerque NMCC site use the N-Power platform.

All in all, Dr. McAneny believes that the N-Power platform has elevated provider awareness of clinical trial opportunities in the practice and has incorporated clinical research as a routine part of the workflow for patient care. The “superscribes” not only help to save time for providers, but also enhance the overall quality of documentation, as they often find discrepancies in notes while reviewing a patient’s case. The prospective data curation empowered by the Kaleido™ Registry has worked well to identify suitable trial candidates at the institution. Additionally, Dr. McAneny’s team has leveraged data from the N-Power Registry CMS for MIPS (Merit-based Incentive Payment System). Dr. McAneny reports that since partnering with N-Power, her site has met all metrics for getting patients on the registry and enrolling patients onto trials in a timely manner. Moreover, they have been able to demonstrate that their community oncologists are conducting next-generation sequencing (NGS) testing at similar rates as academic oncologists. These findings have recently been accepted for presentation at the 2024 ASCO conference.

Regarding opportunities for growth with N-Power, Dr. McAneny pointed out that occasionally, the goal of opening more trials at community oncology centers will conflict with the site’s current capacity. For N-Power, an important objective is to empower sites to open more trials, while Dr. McAneny also has the goal of ensuring the clinic’s ability to enroll patients and close trials expediently. Identification of suitable trials is a complex, multifactorial decision that looks different for each clinical practice. For example, which imaging scans are covered by the trial? Which scans will need to be billed through insurance? What are the costs to open the trial? How much time will it require from the PI? Will it be appropriate for the clinic’s patient population (i.e., patients who do not have the means to travel 3 times per week for follow-up and lab work)? The right trial should be a good fit for the site’s patient population, garner physician interest and support, have economic terms that are suitable for all parties, and minimal procedural barriers. Just because a site can open a particular trial, does not always mean that it should.

Despite these complexities, it is clear that N-Power Medicine is making a strong impact on the ability of community oncology centers to conduct clinical research and offer novel therapies to traditionally underserved patients. By prospectively generating data and creating a single platform where all routine patients become potential research candidates, N-Power Medicine is helping to cultivate a world where every patient and their data can contribute to accelerated drug development in this new era of personalized cancer care.

The 2nd Annual Health Equity in Clinical Trials Congress took place from May 8 – 9, 2024 in Atlanta, Georgia. This conference is one of the few—if not only—large scale settings for various stakeholders throughout the clinical trial ecosystem, including patients, to come together to discuss challenges and opportunities surrounding health equity in clinical research. This year, among the 250+ attendees, the audience consisted of 32% pharmaceutical company representatives, 20% health plan organizations, 15% patient advocacy and non-profit groups, 13% clinical trial service providers, 13% research sites and academics, 5% biotechnology companies, and 2% regulatory and government agencies.

The 2-day event focused heavily on bringing the voice of patients and patient advocates to industry partners to help them understand challenges and barriers to participation in clinical trials. Some featured talks included:

• “Patient Perspectives: Progressing Health Equity and Empowering Underserved Communities”
• “Reducing Burden and Optimizing Experience for Under-served Patient Populations”
• “Data Driven Solutions and Successes for Clinical Trial Diversity”
• “Indigenous and Native, Hispanic, and Arab Community Engagement: Empowering Local Participation in Clinical Trials”
• “Overcoming Access Barriers to Healthcare for the Sexual and Gender Minority Community”
• “How to Engage with Maternal Women of Color in Clinical Research”

There was also a series of roundtable discussions on topics such as:

• “How to Ensure Community Engagement is Truly Trust-centric”
• “How Can We Alleviate Inclusion/Exclusion Criteria to Improve Clinical Trial Diversity”
• “How to Create a System Where Trials are Easy to Understand and Find for Underrepresented Populations”

During the discussion regarding inclusion/exclusion criteria, for instance, participants identified various criteria that could lead to exclusion of underrepresented populations: age limits, BMI range, HIV status, gender identity, and different biomarker levels for certain racial groups.

The key takeaways from the conference included the following points:

• Unified Collaboration Enhances Health Equity Strategy – collaboration between communities, patient organizations, and vendors will enhance efficiency for health equity initiatives.
• Intersectional Engagement Reduces Social Determinants of Health Barriers -- intersectional engagement with the community can help reduce barriers posed by social determinants of health.
• Poor Data Design Blocks Measurement of Racial Equity – there is not enough data about racial differences in clinical trials.
• Inclusive Data Systems Need Overhaul for Accuracy – we need more robust data systems to capture gaps in data.
• Patient Co-Design Trials for Achievable Targets – patients must be part of trial design to ensure that trials are feasible for a diverse population.

The conference presented several important calls to action for attendees and the medical society at large:

• Ensure that all stakeholders have a voice in the clinical trial process
• Educate all stakeholders
• Include diverse patient populations in all phases of research

For industry partners, it is critical to include the patient perspective during protocol design. This could be achieved by inviting patient advocacy groups to review research protocols. It could also be beneficial to have physicians who treat marginalized patient populations to review specific protocols and simultaneously send protocols to local community organizations for feedback before site activation.

Thorough patient education is essential for helping patients to enroll in clinical trials and remain enrolled in the trial through completion. Likewise, educating trial sponsors and protocol writers about health equity and diversity concerns will help to create more inclusive trial protocols. Lastly, diverse patient populations should be prioritized from the very first phases of in-human trials and continued throughout larger studies. Protocol design may need to be more flexible to be inclusive of diverse populations, which circles back to the importance of understanding the patient perspective. ACCC members are encouraged to take these conference highlights and implement them into their practice settings however they can. For those who are interested in the Health Equity Congress for next year, more information can be found here.

When Tigerlily founder and CEO Maimah Karmo discovered she had breast cancer in her late 30’s, she found it incredibly difficult to navigate the health system as a patient and especially as a young Black woman. Today, as a 15+ year survivor, she recognizes that Black women continue to be underrepresented in clinical trials: Black women comprise only 1-3% of trial participants despite being 7 times more likely to die from breast cancer.1 Karmo founded the Tigerlily foundation, a national women’s health and oncology organization providing education, awareness, advocacy and hands-on support to young women (ages 15-45) – before, during and after cancer. In line with this mission, Tigerlily foundation has partnered with Ancora.ai to develop a clinical trial finder tool.

Powered by artificial intelligence, the clinical trial match tool empowers patients to identify breast cancer clinical trials for which they are likely to be eligible. These personalized results are gathered based on each patient’s reported unique characteristics, including tumor type (LCIS, DCIS, etc.), tumor stage, treatment history, age, ethnicity, dozens of genetic markers, and real-life logistical concerns. Trials can be further categorized based on active recruitment (vs. not yet recruiting), travel distance necessary (10, 50, 100, 400, 1000 miles away), trial phase, and trial type (interventional, observational, etc.). A particularly useful feature is the Match Score: each trial receives a score based on the fit of trial inclusion/exclusion criteria to the patient’s individual characteristics. Trials are labeled as “excellent match,” “good match,” “fair match,” or “limited match” and displayed in order of fit. The full list of trials for which the patient is potentially a candidate can be exported to an Excel file and printed out to share with the patient’s health care team.

One of the approaches utilized by Tigerlily foundation to encourage inclusivity and support diversity in clinical trials is the organization of participant advisory boards (PABs). Actively engaged patient advocates meet regularly to advise trial sponsors about clinical trial design as well as the presentation of study materials, with the patient’s perspective and experience in mind. Trial documents such as the informed consent form, study protocol, recruitment materials, and the diversity plan are reviewed by the PAB. Recommendations and suggested actions are given back to the sponsor prior to trial initiation. Examples of recommendations include adding a layperson-friendly glossary to provide definitions of terms and acronyms as well as encouraging trial sponsors to allot funds for transportation options such as ridesharing.

Every month, the trial finder tool is used by approximately 1000 patients and their loved ones. On average, it takes each user 5 minutes to navigate the tool and access an individualized list of potential clinical trials. The clinical trial matching tools featured on the Tigerlily website were selected for ease of user experience, transparency, and support for diversity and inclusion in clinical trials. The Tigerlily foundation Tiger Trials Search feature can be found here: Trial Match – Clinical Trials | Tiger Trials | Tigerlily Foundation.

References

1. Wright N, Akinyemiju T, Subhedar P, et al. Targeting risk factors for reducing the racially disparate burden in breast cancer. Front Biosci (Schol Ed). 2019;11:136-160