Research sites to test tools aimed at improving diversity in cancer clinical trials
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As part of a partnership to increase clinical trial participation among underserved racial and ethnic groups, ASCO and Association of Community Cancer Centers plan to test a research site-evaluation tool and implicit bias training program.
Both projects aim to address major institutional- and provider-level barriers to trial participation that result in failure to routinely offer clinical trials to eligible patients from historically underrepresented groups.
“This is a problem that we all need to be concerned about,” steering committee co-chair Randall A. Oyer, MD, immediate past president of Association of Community Cancer Centers (ACCC), said in an interview with Healio. “There are areas of the country that have high levels of socioeconomic deprivation, and these areas have lower cancer survival. And that is linked to biases within our health care system, specifically in terms of poor access to clinical trials.”
A structural framework
The pilot project was launched in July 2020 with a request for ideas from the oncology community. ASCO and ACCC are recruiting more than 40 oncology research sites to participate in the site assessment and implicit bias training program. The assessment tool will evaluate structural and procedural considerations that may affect patient screening and participation. The implicit bias training will be curriculum-based and will include interventional exercises and educational scenarios.
“ASCO and ACCC are working together on two different fronts to create a tool that will help sites to understand where they may be losing minorities in clinical trial enrollment,” Lori J. Pierce, MD, FASTRO, FASCO, steering group co-chair and chair of ASCO’s board of directors, told Healio. “We want them to see where along the continuum more effort is needed to maintain a robust representation.”
The assessment tool will be tested at both small and large research sites within community- and academic-based oncology programs from diverse areas of the country. The sites will be given a stipend for complete participation.
According to Oyer, the tool will consider the leadership and recruitment efforts of an institution when planning and enrolling onto clinical trials.
“For example, the leadership of an organization may or may not be devoting resources to bringing in clinical trials,” he said, “They may or may not be training their staff on what the requirements are or training their staff on explicit and implicit bias. This is all very important. The site-assessment tool can be looked at as the structural framework, while the implicit bias training will consist of ongoing work with individuals who need to have their behavior and their practices improved.”
Oyer noted that one of the most essential parts of recruiting individuals from underserved communities for clinical trials is simply offering patients the option.
“Sometimes when researchers are considering a potential clinical trial participant, they want the youngest, healthiest, easiest patient to care for, the patient who needs the least assistance or has the fewest questions,” he said, “They might think, ‘This will be an easy person to involve in a trial — they came in and asked about it, they were already thinking about it.’ A practitioner who has a poor understanding of what they are supposed to do may not make an extra effort.”
Reducing implicit bias
The implicit bias training will have an institutional component and an individual aspect, according to Pierce. The institutional component will involve specific scenarios and interventions designed to better educate researchers.
“They are going to be very specific vignettes focusing on what the barriers were for the patients in those scenarios,” she said. “Our efforts are to focus on an overview of the issues in terms of health disparities and health equity and being mindful of the need to increase diversity.”
The training focused on individual researchers will be confidential and handled with sensitivity but ideally will bring about a change in thinking.
“With the individual piece, there will be an assessment before and after engaging with that tool and it will be very confidential, but will hopefully be able to enlighten the individual about their biases,” Pierce said. “By walking them through a lot of the data on disparities and then looking at those vignettes, we hope a light bulb will be turned on, and it will be evident in the pre- and post-assessment.”
Pierce emphasized that everyone has implicit biases, and that remaining mindful of them requires ongoing effort.
“Implicit bias training is not a one-and-done thing,” she said. “We have to be constantly improving ourselves, so that we continue to take what we’ve learned and implement it in our daily lives.”
Diversity and community
Increasing minority enrollment in clinical trials is essential for several reasons beyond providing underserved patient populations with what often is the best available treatment for their cancer, according to Oyer and Pierce. Including a diverse patient population is necessary to understand cancer mechanisms and the efficacy and toxicities of treatments in all patients, Pierce said.
“If we don’t include a broad population, if we don’t include all the people who have the condition we’re trying to study, you can’t extrapolate to a diverse population of patients,” Pierce said. “The population that you’ve studied isn’t the same as the population that will be treated or will need to be treated. So, there’s an imbalance.”
Oyer noted the importance of working with underserved communities at the clinical trial sites. He said the project has a patient advisory group that is involved in ensuring community participation.
“It takes many stakeholders to be able to address this — we have to work with institutions, governments and pharmaceutical companies,” he said. “We also need to work with communities.”
He recalled a comment made to him by a patient advocate years ago when listening to his plans for a health equity project.
“She asked, ‘Where’s the patient at the table? Nothing about us without us,’” he said. “That has stuck with me and has changed my approach. We need to listen to the community we’re trying to help.”
For more information:
Randall A. Oyer, MD, can be reached at Penn Medicine Lancaster, 2106 Harrisburg Pike, Lancaster, PA 17061; email: randall.oyer@pennmedicine.upenn.edu.
Lori J. Pierce, MD, FASTRO, FASCO, can be reached at Rogel Cancer Center at University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI 48109; email: ljpierce@umich.edu.
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