The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
The American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) are combining their efforts to increase racial and ethnic diversity in clinical trials.
“Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments,” the organizations said in a joint statement Friday.
The research report includes six key recommendations:
1.) Clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate...All organizations that sponsor, fund and administer cancer clinical trials should demonstrate clear commitment to improving equity, diversity and inclusion (EDI).
2.) Trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing equity, diversity and inclusion (EDI), and work with sites to conduct trials in ways that increase participation of under-represented populations.
3.) Trial sponsors, researchers and sites should form long-standing partnerships with patients, patient advocacy groups and community leaders and groups.
4.) Anyone designing or conducting trials should complete recurring education, training and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication and a commitment to achieving EDI in clinical trials.
5.) Research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce.
6.) Research stakeholders should collect and publish aggregate data on the racial and ethnic diversity of trial participants when reporting the results of trials, programs and interventions to increase EDI.
The announcement follows another partnership revealed Thursday between Pfizer and Headlands Research to launch new clinical trial sites in areas with highly diverse populations. Their first location will be Brownsville, Texas.
Health equality is improved when those participating in the clinical trials are reflective of the patients that will use the tested medical products. This is particularly pertinent given that minority groups are disproportionately impacted by certain diseases.
To illustrate the disparity in the number of minority participants in clinical trials, a 2019 paper led by Dr. Jonathan Loree, a medical oncologist and assistant professor at the University of British Columbia and Dr. Kanwal Raghav, an associate professor in the department of gastrointestinal medical oncology at MD Anderson Cancer Center, analyzed 230 oncology clinical trials between 2008 and 2018 that resulted in U.S. Food and Drug Administration (FDA) approvals. Of the 18 trials that provided a population breakdown of what the authors referred to as the four major races in the United States, whites made up 76.3%, Asians accounted for 18.3%, Hispanics 6.1% and Black/African Americans just 3.1%.
The paper concluded, “Given the growing racial and ethnic pluralism in society, it is a scientific and ethical imperative to ensure that our research reflects and benefits all.”
FDA Commissioner Robert M. Califf, M.D. issued a similar statement in April.
“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated products is fundamental to public health,” he said.
Califf’s comments came as the FDA issued draft guidance intended for industry sponsors developing medical products for the purpose of developing a Race and Ethnicity Diversity Plan.
The report was authored by a host of FDA divisions including the Oncology Center of Excellence (OCE), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) and Office of the Commissioner, Office of Minority Health and Health Equity (OMHHE).
The FDA is also promoting the OMHHE’s “Diversity in Clinical Trials Initiative,” which includes promoting public education and an outreach campaign directed toward increasing minority participation in clinical trials.
Additionally, the OCE launched its “Project Equity” which is designed “to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of patients for whom the medical products are intended.”
One hindrance to achieving the inclusion of minorities in clinical trials is a mistrust of the life sciences and medical communities.
Mónica Guerrero Vázquez is the executive director of Centro SOL, an outreach organization of Johns Hopkins University whose goal is to advance educational opportunities for Latinx high school students in Baltimore. She told BioSpace how the mistrust of the Latinx community toward the pharmaceutical industry plays a role in their lack of participation in clinical trials.
“We saw during COVID, there was no trust because it was like, ‘Okay, I’ve never had access to this [medical care]. Are you kidding me? Don’t ask me anything.’” Another person told Vázquez, “I don’t have access to health care. Why do you want me to participate in this?”
Grassroots organizations like Latinos in Clinical Research (LICR), which has members throughout the southwest and California, are working to inform their communities about how they can benefit from clinical trials. LICR Co-founder Monica Cuitiva told BioSpace what her group is doing to increase the number of Latinx individuals involved in clinical trials.
“We’re getting people that are not yet in clinical trials and trying to help them learn more about it and where they could be a potential patient. Our aim is to educate from the grassroots which means we’re trying to educate even the children that are finishing school to know more about clinical trials,” she said.
Another issue potentially accounting for the lack of minorities in clinical trials is that they don’t see people like themselves working in oncology jobs.
According to a 2022 ASCO report, representation in the oncology workforce was only 4.7% Latinx, and 3% Black. Correspondingly, Latinx individuals make up 18.7% of the U.S. population and Black Americans represent 14.2%, per the U.S. Census Bureau. By 2060 those percentages will increase as Latinx individuals are projected to account for 29% of the total populace and Black/African Americans more than 16%.
“We know that across all healthcare, basically, Blacks, Latinos, Pacific Islanders, Hawaiians and Native Americans are severely underrepresented. Among all the medicine sub-specialties, oncology actually is the least diverse,” Ana Velázquez Mañana, M.D, a clinical instructor in medical oncology in the division of hematology/oncology at the University of California San Francisco (UCSF), told BioSpace in a previous interview.
To tackle the issue of the lack of minorities in medical professions, ASCO and UCSF announced an internship program for populations underrepresented in medicine.
Finally, there is the financial impact of racial disparities in health care. A 2020 AACR report projected that eliminating health disparities for minority groups would have led to a reduction in direct medical costs of about $230 billion and indirect costs from illness and premature death of more than $1 trillion between 2003 and 2006.
Cancer is the second leading cause of death in the United States behind heart disease, according to the Centers for Disease Control and Prevention with 602,350 people dying each year. Improving efforts to increase racial and ethnic diversity in cancer clinical trials is a crucial starting point to combatting cancer’s many forms in the diverse segments that increasingly represent a larger portion of the U.S. populace.
With files from Heather McKenzie
