Now is the Time to Improve Diversity in Cancer Clinical Trial

In Partnership With:

Partner | Cancer Centers | <b>Montefiore Einstein Center for Cancer Care</b>

Fewer African American and Hispanic patients participated in oncology trials from 2003 to 2016 than from 1996 to 2002.

Fewer African American and Hispanic patients participated in oncology trials from 2003 to 2016 than from 1996 to 2002.1 Moreover, according to the 2020 Drug Trials Snapshot Summary Report, of the 4922 participants whose data supported FDA approval of 18 new oncology drugs in 2020, only 5% were Black and 6% Hispanic.2

Diversity in clinical trials remains an elusive goal. And understandably so. Reports of the abuse of minority patients are common in medical research. We’re all familiar with the infamous syphilis studies carried out at Tuskegee during a large part of the 20th century.3 It wasn’t until 2020 that the family of Henrietta Lacks—the Black woman whose cell line has for decades been the basis for a multibillion-dollar biotechnology industry—began receiving financial compensation. Lacks died of cervical cancer in 1951 without ever being consulted about the research. These abuses, combined with language barriers and other hurdles, often lead members of minority populations to ask: “What would be the benefit for me and my family of participating in a clinical trial?”

In January, Montefiore Health System and Albert Einstein Cancer Center were awarded a $5.9 million grant from the National Cancer Institute (NCI) to build upon our success at recruiting minority and underserved patients for cancer clinical trials. The new grant is administered by the NCI Community Oncology Research Program (NCORP) and a continuation of the funding we first received in 2014.

Our cancer center, based in the Bronx, New York, is one of only 14 NCORP Minority/Underserved Clinical Sites. The designation means that the trials enroll at least 30% of participants from racial/ethnic minorities or rural areas. We are proud that 80% of the participants in our clinical trials are minorities, 72 percentage points more than the nationwide average.

Our success at recruiting diverse populations is due in part to our ongoing research into community attitudes about recruitment. In 2018, we surveyed more than 1350 nonpatient residents in our catchment area. Results showed that 88% of Bronx residents trust their doctors and hospitals “a lot” or “a fair amount.” However, only 56% of non-Hispanic Black and Hispanic respondents agreed that “cancer care in your community is excellent,” compared with 74% of non-Hispanic White respondents.

The perception that cancer care in the Bronx is excellent was notably higher among the 110 cancer survivors in our sample (of whom 74% were non-Hispanic Blacks, 80% Hispanic, and 79% non-Hispanic Whites) than among the 903 family members of current and past patients with cancer (55% non-Hispanic Blacks, 58% Hispanic, and 76% non-Hispanic Whites).

Attitudes toward clinical research also varied greatly (Figures 1 and 2). Although most Bronx residents understand its importance, many are concerned about safety and suspicious about the motives of scientists. Again, racial and ethnic differences were evident of non-Hispanic Black respondents held the most favorable attitudes toward research, compared with 19% of non-Hispanic Whites (Figure, cluster 1). Conversely, 26% of non-Hispanic Black respondents, compared with only 11% of non-Hispanic Whites, were in the group that was most suspicious about researchers’ intentions despite recognizing the need for research (Figure, cluster 3).

Nevertheless, it is important to stress that the main reason respondents gave for not participating in past research was that no one had asked them. These findings reinforce the need to constantly refine our strategies for clinical trial enrollment.

Three Keys to Success

Just as with any relationship, successful accrual of participants requires work. Our NCORP team has identifiedpromising strategies (Figure 3):

Maintaining Effective Working Relationships With Providers and Clinic Staff

For those of us involved in clinical research, logistics must be a labor of love. Finding ways to shift administrative tasks away from providers and staff is a priority. Support with patient eligibility screenings is only the beginning. Teaching the staff about research procedures and materials and allocating space for researchers and clinic staff to conduct research is also imperative. Missed appointments, late arrivals, and unexpected patient care issues must also be accommodated. During the course of every study, our team monitors patient accrual and provides feedback to clinics about what worked and what needs improvement.

Engaging Physicians as Study Champions

Even at an academic cancer center, it can be difficult for clinicians to carve out time for research. Those who become involved with NCORP early in their careers have the opportunity to contribute substantively to research and expand their professional and academic networks. NCORP funds pilot studies focusing on cancer health equity to help new faculty members launch work that addresses the needs of underserved and underrepre-sented patients.

At our center, employing these strategies has allowed investigators to address disparities in various ways through a screening program that prevents diagnoses of stomach cancer in the emergency department, fitness trackers that support patients undergoing radiation for lung cancer, and prostate cancer treatment aids tailored to men of ethnic minorities.4-6

Building Rapport With Patients and Families

The accrual process must meet the needs of potential participants. Many patients in our system have difficulty reading and are reluctant to say so. For that reason, our research staff reads consents, surveys, and other materials, unless the patient expresses a preference for reading. Signing a consent from can be problematic for some patients, especially if the document is unclear to them.

Patients who live in low-income communities like the Bronx are significantly affected by the social determinants of health. That’s why we have clinic navigators who identify challenges such as lack of money, transportation, or caregiver support and find resources to help.

As our data shows, most members of our community have preconceived notions about medical research. Their social network influences their decision to participate in a trial. Which is why we partner with area hospitals, schools, and the Stand Up to Cancer foundation to address knowledge gaps. Education about the importance of diversity in trials—and the safeguards in place—is essential. Equally important are the opportunities for community members to meet investigators outside the clinic and get a sense of the cancer research that is being conducted in their backyard.

A Teachable Moment

A cancer diagnosis is traumatic and can overwhelm the strongest among us. But imagine receiving such news if you are aware of historical mistreatment at the hands of the medical profession or if English is not your native language.

To ensure that the newest options in cancer prevention, screening, and treatment benefit everyone, we must do everything in our power to make clinical trials open to all. We must share our findings widely so that those who have traditionally been excluded can begin to see the benefits of participation—for themselves, their children, and their grandchildren.

The COVID-19 pandemic continues to shine a bright light on health disparities. Now we have a unique opportunity to open a dialogue with the communities we serve about how best to further science and medicine. Physicians as well as patient advocates must act to enhance diversity in clinical trials and make certain that the latest cancer therapies are tailored and accessible to all. We hope that the lessons we have learned help others to succeed in this endeavor.

References

  1. 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(1):e1-e10. doi:10.1200/JOP.2017.025288
  2. U.S. FDA. 2020 Drug trials snapshots summary report. February 2021. Accessed January 26, 2022. bit.ly/3H3GAUj
  3. Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health. 1997;87(11):1773-1778. doi:10.2105/ajph.87.11.1773
  4. In H. Can we preempt emergency department diagnoses of stomach cancer? OncLive®. August 1, 2019. Accessed August 11, 2021. https://www.onclive.com/view/can-we-preempt-emergency-department-diagnoses-of-stomach-cancer
  5. Purswani JM, Ohri N, Champ C. Tracking steps in oncology: the time is now. Cancer Manag Res. 2018;10:2439-2447. doi:10.2147/CMAR.S148710
  6. Tilburt JC, Pacyna JE, Petereit DG, et al. Decision aids for localized prostate cancer: Initial outcomes from NCI Community Oncology Research Program Alliance Research Base Cancer Care Delivery Research (CCDR) Protocol-A191402CD-A Cluster-Randomized Trial. J Clin Oncol. 2020;38(suppl 15).:e24176. doi:10.1200/JCO.2020.38.15_suppl.e24176