Race and Medicine

Race and Medicine

Source:

Healio Interviews

Disclosures: Oyer and Pierce report no relevant financial disclosures.
July 31, 2020
5 min read
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ASCO-ACCC collaboration aims to make clinical trial diversity ‘part of our DNA’

Source:

Healio Interviews

Disclosures: Oyer and Pierce report no relevant financial disclosures.
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Two prominent oncology organizations have launched a collaboration designed to increase racial and ethnic diversity in cancer clinical trials.

Representatives of ASCO and Association of Community Cancer Centers (ACCC) hope to identify novel strategies and practical solutions to ensure trial participation rates among traditionally underrepresented populations better reflect the overall population of individuals with cancer.

Infographic with key points about ASCO-ACCC collaboration

“Clinical trials are the foundation of cancer research and are vitally important to ensure the best possible care for our patients,” ASCO President Lori J. Pierce, MD, FASTRO, FASCO, told Healio. “If clinical trials don’t represent the individuals we treat ... patients with life-threatening conditions may miss out on the best — and perhaps only — treatment options for their condition.”

Lori J. Pierce, MD, FASTRO, FASCO
Lori J. Pierce

A steering group that includes representatives of both organizations will oversee the initiative. The group will encourage ASCO’s 45,000 members and ACCC’s 25,000 members to submit their ideas for consideration via this online form.

In addition to improving individual patient care, the collaboration can help minimize the broader negative effects underrepresentation of racial and ethnic minority populations in cancer trials has on the field of oncology, ACCC President Randall A. Oyer, MD, told Healio.

Randall A. Oyer, MD
Randall A. Oyer

“Bias due to underrepresentation is a critical threat to the validity of trial results and can exacerbate existing health disparities,” Oyer said. “If certain people are not represented in a trial, the results may not be applicable to them. Trials may not be accessible to patients simply because of where they live, and they don’t always accrue sufficient numbers of patients needed to ensure scientific validity. All of these factors underscore the importance of this effort.”

‘This issue is not new’

Black individuals account for approximately 15% of patients with cancer in the United States but only 4% to 6% of cancer trial participants.

Hispanic individuals account for 13% of patients with cancer but only 3% to 6% of trial participants.

“This issue is not new,” Pierce told Healio. “President Clinton signed the NIH Revitalization Act in 1993, and the purpose was to increase representation of women and minorities in clinical trials. Since that time, there have been some improvements but there has not been a consistent move forward. I think that has to do with the complexity of the issues. There’s no one thing causing this. It is a multitude of factors.”

Potential barriers to trial participation include socioeconomic and education status, access to care in a geographic region, cost of care, insurance coverage, provider bias, lack of awareness of trials, lack of trust of the health care system, or cultural or literacy-related factors.

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These variables are intertwined, Pierce said.

For example, a patient’s work schedule or financial circumstances may impede trial access; a practice’s finances may dictate whether an additional nurse practitioner or physician assistant can be dedicated to educate patients about the benefits of clinical trials; and literacy issues or language barriers may prevent patients from fully understanding the reason why a trial is being conducted, potentially contributing to mistrust.

“It’s like peeling the layers of an onion,” Pierce said. “You begin to see how connected many of these issues are, and the complexity of the questions we’re trying to address. If each of these barriers was easy to address, they would have been addressed before.”

A natural partnership

Oyer took over as ACCC president in March. He adopted the theme “Community oncology can close the gap in cancer research,” with a focus on underserved populations, geriatrics and models of care.

Pierce began her term as ASCO president in June, choosing the theme “Equity: Every patient. Every day. Everywhere.”

ASCO CEO Clifford A. Hudis, MD, FACP, FASCO, noticed the common thread in their missions and facilitated an introduction. Early on, Oyer and Pierce agreed they could achieve greater success if they worked together.

They formed a steering group comprised of clinicians and researchers who have been involved in prior efforts to increase trial diversity.

The two organizations also established the ASCO-ACCC Request for Ideas (RFI) online platform, which allows members of the clinical community to share their own practical solutions with the steering group. These could be strategies that have been implemented successfully at an individual practice or novel ideas that have never been tried.

“We are looking for the most promising strategies or solutions that are likely to remove barriers to trial participation, while making sure they are sustainable, scalable and amenable to scientific study,” Oyer said.

The steering group will review all ideas and combine or modify them as appropriate.

“We are going into this with an open mind,” Pierce told Healio. “We do not have any preconceived ideas of what will be successful and what won’t, so no idea will be dismissed.”

The RFI component of the initiative will be open through Aug. 24.

Pierce and Oyer will review ideas with steering group members this fall, decide by the end of this year which ideas they want to carry forward, and then begin implementation in early 2021.

Some of the strategies selected for implementation may be evaluated in ASCO’s TAPUR study, a nonrandomized trial designed to evaluate the efficacy and safety of FDA-approved, targeted cancer therapies for patients with advanced cancer who harbor potentially actionable genomic alterations.

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Individuals whose ideas are chosen to move forward will have the opportunity to participate in their implementation.

A toolkit for success

Pierce and Oyer acknowledged variations in communities across the country — as well as the challenges they must overcome — make it unlikely that one-size-fits-all strategies will emerge from this effort.

Consequently, their goal is to provide a toolkit to help providers overcome the barriers most prevalent in their communities, whether they be related to assessment, training, education or communication.

“It’s also very important that we identify the level at which we need to make the intervention, whether it be the patient, physician, program or community level,” Oyer said. “One intervention alone won’t be enough. We’re really going to need to change the whole ecosystem.”

Although the initiative is designed to increase clinical trial enrollment among traditionally underrepresented populations, retention of those patients on study will be a key measure of success, Pierce said.

The development of structural and policy changes that make this effort sustainable also is crucial, Oyer said.

“We want this to continue beyond an initial effort that involves a small group of really enthusiastic people,” he said. “We want this to become part of our DNA.

“Cancer care in this country is very good but it can always be better,” Oyer added. “We have made so many strides in cancer research, yet not all Americans have benefited equally. Until that happens, I don’t think we’re there yet.”

References:

For more information:

Lori J. Pierce, MD, FASTRO, FASCO, can be reached at ljpierce@umich.edu.

Randall A. Oyer, MD, can be reached at randall.oyer@pennmedicine.upenn.edu.