Mar 07, 2021
By Patra Wroten
For years, study after study on cancer clinical trial participation has found similar barriers to patient participation: access and eligibility.
“Many people assume that participation rates are all patient-related factors and don’t consider the structural barriers to accrual. In order to improve accrual, it is important to understand all the barriers that can potentially be fixed,” said Dawn L. Hershman, MD, MS, director of breast oncology at Columbia University Medical Center, and a four-time Conquer Cancer Grant & Award recipient.
Dr. Hershman was a lead author of a study published in the Journal of the National Cancer Institute in October 2020 on the willingness of patients with cancer to enroll in clinical trials. The study revealed that when patients are invited to take part, more than half will say yes.1
“Interestingly, there were no differences in rates of participation between minority and non-minority patients,” said Dr. Hershman. “Encouragingly, the rates have increased over time.”
To ensure cancer clinical trial participants best represent the diverse population of patients with cancer, Dr. Hershman believes oncology leaders “have to improve our understanding about how to communicate about trials and the benefits to patients.”
The lack of racial and ethnic diversity in clinical trials continues to be a problem in cancer research, and funding for clinical trials remains a vital need. Recent analyses of cancer clinical trials found that only 4% to 6% of trial participants are Black and 3% to 6% are Hispanic, whereas these populations represent 15% and 13% of all patients with cancer, respectively.2,3 The U.S. National Cancer Institute shows higher enrollment rates for its studies at 11% and 10%, respectively.4 If clinical trials fail to represent the full population of patients with cancer, the state of science suffers and patients with life-threatening conditions may miss out on the best—perhaps only—treatment option for their disease.
Conquer Cancer is increasing grant and award opportunities to expand equitable clinical trial access for patients. The foundation continues raising funds for research and education resources to support ASCO’s commitment to equitable health care, providing platforms for thought leaders to drive solutions towards equity in cancer care, and ensuring oncologists, researchers, and medical students have the resources they need.
"Our mission to conquer cancer worldwide directs us to look at the best ways to serve all patients and to elevate the quality of research and programs through our support,” said Nancy R. Daly, MS, MPH, CEO of Conquer Cancer. “Though cancer does not discriminate, it affects many patients disproportionately, and it has never been more important to unite and challenge our community to address the unique needs of every patient.”
Uniting Leaders in Oncology
“Many factors serve as barriers to clinical trials. Some of these factors include language, complicated consent forms, lack of insurance to have the initial tests to assist with qualification to a trial, the patient’s comorbidities, and the lack of being offered a trial due to some of these barriers. There are also many cultural barriers for Latinos, such as fear of being a guinea pig [in a trial],” said Amelie G. Ramirez, DrPH, MPH, chair and professor of population health sciences and director of the Institute for Health Promotion Research at the UT Health Science Center of San Antonio.5
Dr. Ramirez is an expert on Latino health disparities. In November, she was among the speakers at the virtual 2020 Conquer Cancer Council (CCC) Annual Meeting, “Increasing Underrepresented Racial and Ethnic Patient Participation in Clinical Trials.”
The CCC unites stakeholders from for- and nonprofit organizations to discuss challenges, explore potential solutions, and exchange ideas to improve the quality of care for patients with cancer. For the past 2 years its annual meeting has focused on equity, diversity, and inclusion issues in clinical research, reflecting ASCO’s priority to increase patient access to clinical trials noted in its 2019 Research Priorities to Accelerate Progress Against Cancer (see sidebar below). A similar focus is expected later this year.
Dr. Ramirez joined other leading voices in health disparities as a meeting panelist, including Nadine J. Barrett, PhD, of Duke University School of Medicine and Duke Cancer Institute; Lola Fashoyin-Aje, MD, MPH, of the U.S. Food and Drug Administration Office of Oncologic Diseases; Sanford E. Jeames, DHA, of Eastside Memorial Early College High School and Huston-Tillotson University; and Randall A. Oyer, MD, of the Penn Medicine Lancaster General Health Ann B. Barshinger Cancer Institute.
Dr. Oyer, president of the Association of Community Cancer Centers (ACCC), gave an overview of the ASCO-ACCC initiative to identify and implement novel strategies and practical solutions to increase clinical trial participation of racial and ethnic minority populations, which he established with 2020-2021 ASCO president Lori J. Pierce, MD, FASTRO, FASCO. Other topics discussed included solutions for reaching men of color, building trust in local communities by engaging health providers and health care companies, and adopting language—choosing action terms and descriptions of underrepresented groups—that positively impacts communication.
For example, “the word ‘trial’ in the Latino community has a connotation to a legal trial,” explained Dr. Ramirez, “so we use the word ‘study’ to avoid confusion with our patients.”
Nearly every speaker and participant echoed similar calls to action toward the goal of increasing clinical trial access: take time to understand patients beyond their diagnosis, ensure oncologists are representative of patients’ communities, and invest in opportunities to focus research on populations underrepresented in cancer care.
“I've worked in clinical research and tried to move the needle on this topic 20 years ago,” said Kim Hart, director of patient alliances and public relations at Taiho Oncology. “While there is still significant work to do, the Conquer Cancer Council Annual Meeting reinforced that it is absolutely critical that there be community engagement and stakeholders within these underserved populations to enact meaningful and sustainable change.”
Understanding Patient Disparities
At the CCC Annual Meeting, attendees were asked to discuss four hypothetical clinical scenarios. They were given patient profiles which, along with age and disease type, included the patient’s race, profession, family support system, location, and other socioeconomic factors. From trust issues about science to the cost of parking at a hospital, the goal was to challenge the participants to consider the nuanced disparities that contribute to the access barriers many patients face.
“It’s important for physicians to understand a patient’s social determinants of health. These include the economic and social conditions that impact the patients—where they come from, what are other family issues that might be impacting the patient’s health, are they able to take off work to participate in a trial, does the patient have stable housing and transportation, can the patient be seen at other times so the patient does not have to miss work or lose work pay because they might not have sick leave, etc.,” explained Dr. Ramirez. “Having a better understanding of these conditions helps the physician see the patient in a more holistic way.”
As the group worked through the task of understanding the obstacles patients must weigh when considering clinical trial participation, participants discovered how these obstacles—particularly for people who do not speak English and who experience systemic racism and access issues—impact a patient’s interest in and ability to participate in a clinical trial, in addition to dealing with the effects of their disease and its treatment.
Dr. Ramirez hopes that as race in health care becomes an issue more frequently and freely discussed, patients will come to expect that doctors will know and understand the range of disparities they face.
“Patients report doctors as their main source of health information, which is why it is important to place doctors in the community who are members of that community—for trust,” Dr. Ramirez said. “A valuable step a health leader can take to close disparity gaps is to help ensure a more diverse oncology workforce.”
Opening Doors in Oncology
The oncology workforce lacks adequate representation of racial and ethnic minorities, with only 3% of practicing oncologists self-identifying as Black or African American and 4.7% as Hispanic or Latino. Only 0.1% of oncologists are American Indian or Alaskan Native. Likewise, women are underrepresented in oncology; only 33.7% of oncologists are women.6
In 2013, then ASCO president Sandra M. Swain, MD, FACP, FASCO, professor of medicine and associate dean for research development at the Georgetown University Medical Center, founded Women Who Conquer Cancer. The program is designed to provide a professional support system and fund the research of women investigators.
Catherine Handy Marshall, MD, MPH, assistant professor of oncology at Johns Hopkins Medicine, is among the 33 researchers funded by WWCC donors to date. She received a 2017 WWCC Young Investigator Award (YIA) from Conquer Cancer to explore the impact of cardiovascular disease risk factors on cancer outcomes. Though the funding supported 1 year of her research, WWCC continues to provide Dr. Handy Marshall with a lifelong network to help accelerate her career.
"Unfortunately, racism and sexism exist in academic medicine the same way they exist in the rest of society, and I have not been immune to that throughout my time in academics,” said Dr. Handy Marshall. "The WWCC YIA helped me forge new collaborations and pursue new projects that continue now, even as a junior faculty member.”
Dr. Handy Marshall, whose research is now focused on clinical trials, is extending the spirit of WWCC as a mentor to her students, particularly women and minorities, as they work to advance their careers and understand the process for how to obtain research funding.
"What became clear to me early on in my academic career was that students do not always fully understand the process and that leads to missteps along the way," said Dr. Handy Marshall. "The goal is to give everyone access to the same preparatory information. My hope is that by doing this, the playing field will be evened a bit."
Going the Last Mile
The number of medical school applicants increased 18% in 2020 compared to 2019, according to the Association of American Medical Colleges (AAMC).7,8 AAMC believes the movement is inspired by the heroism of doctors and researchers during the COVID-19 pandemic. Medical school admissions officers have dubbed the movement “the Fauci effect,” an homage to the pandemic leadership displayed by Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, according to NPR. As a new generation enters the oncology workforce, Conquer Cancer and ASCO are eager to support the success and career development of these future leaders.
Building on the success of initiatives like WWCC and working to increase exposure of medical students to the oncology field, Conquer Cancer and ASCO are expanding programs, as well as grant and award opportunities, for medical students and researchers from underrepresented populations. By targeting students, leaders hope to spark interest, excitement, and passion for the field of oncology.
“2020 both challenged and inspired ASCO and Conquer Cancer to think strategically and act boldly to address issues that have confronted the oncology community and broader medical establishment for years,” said ASCO CEO Clifford A. Hudis, MD, FACP, FASCO. “Unlike any other oncology-focused organization, ASCO’s broad and diverse membership is inspired and equipped to close the disparity gaps in cancer care. We have been change-makers since 1964 and, under Dr. Pierce’s leadership, we are moving faster than ever. Even though the last mile often feels like the longest, I am confident in our impact.”
In addition to the current Medical Student Rotation award, which provides funding and pairs recipients from underrepresented populations in medicine with a mentor to oversee academic and career guidance, Conquer Cancer and ASCO have dedicated awards specifically for medical students and residents and continue to work with donors to build upon existing opportunities.
“We are looking to the future with bold yet practical initiatives to address disparities and work toward achieving greater equity in cancer care,” said Dr. Pierce. “These programs address diversification of the oncology workforce and support for oncologists and trainees from underrepresented populations in medicine. They also include provider training to address gaps in health equity, as well as increasing participation of diverse populations in clinical trials. And of course, they provide important research grants through Conquer Cancer in support of diversity, inclusion, and health equity.”
Sidebar: ASCO Priority Focus for Clinical Trial Access
- Improve understanding of the barriers to trial enrollment among various underrepresented groups, taking into consideration patient, practice, community, and trial-specific factors.
- Develop and test interventions that enhance clinical trial enrollment among underrepresented populations (examples may include use of educational tools, telehealth, and community-based involvement and participatory research).
- Evaluate novel strategies to improve access to clinical research resources in areas with large proportions of underrepresented minorities.
- Develop mechanisms that improve awareness and education about clinical trials among underrepresented groups and the physicians treating them.
- Make use of clinical practice data to study differences in cancer incidence, prevalence, natural history of disease, and treatment experience, including efficacy and toxicity, among underrepresented populations.
- Unger JM, Hershman DL, Till C, et al. "When offered to participate:" A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst. 2020:djaa155. Epub Oct 6, 2020.
- Loree JM, Anand S, Dasari A, et al. Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncol. 2019;5:e191870. Epub Aug 15, 2019.
- Duma N, Vera Aguilera J, Paludo J, et al. Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years. J Oncol Pract. 2018;14:e1-e10.
- McCaskill Steven W. Accrual of Minorities into NCTN and NCORP Clinical Trials: A Twenty Year View. National Cancer Institute. Jun 15, 2020. Accessed Jan 14, 2021.
- Ramirez AG, Talavera GA, Marti J, et al. Redes En Acción. Increasing Hispanic participation in cancer research, training, and awareness. Cancer. 2006;107 (8 Suppl):2023-33.
- ASCO. State of Cancer Care in America 2020. Accessed Jan 14, 2021.
- Association of American Medical Colleges. U.S. Medical School Applications and Matriculants by School, State of Legal Residence, and Sex, 2020-2021. Oct 26, 2020. Accessed Jan 14, 2021.
- Association of American Medical Colleges. Total U.S. Medical School Enrollment by Race/Ethnicity (Alone) and Sex, 2016-2017 through 2020-2021. Nov 3, 2020. Accessed Jan 14, 2021.