Equity Principles Vital for Underserved Populations in Cancer Clinical Trials

Researchers need to understand which patient populations who bear the brunt of specific diseases to build trust, improve diversity in clinical trials, and bridge the racial and equity gaps in cancer research, according to Melissa A. Simon, MD, MPH.

Simon is co-chair of the ECOG-ACRIN Health Equity Committee. One of the group’s core objectives is to help investigators build equity principles into their study designs to ensure underserved populations are recruited and represented.

“It's critically important for cancer because there's so much morbidity and mortality that's associated with cancers across many racial and ethnic minority populations, and other underrepresented or underserved populations,” Simon said. “The opportunities are endless to make your impact in health equity from whatever standpoint you have in the health care, scientific, and public health practice space.”

In an interview with OncLive^®, Simon, vice chair for Research, Department of Obstetrics and Gynecology; director, Institute for Public Health and Medicine (IPHAM)-Center for Health Equity Transformation; George H. Gardner, MD, professor of Clinical Gynecology; professor of Obstetrics and Gynecology (General Obstetrics and Gynecology)/Preventive Medicine, and Medical Social Sciences, Feinberg School of Medicine, Northwestern Medicine; and co-chair, Health Equity Committee, ECOG-ACRIN Cancer Research Group; explained why all researchers, oncologists, and health care professionals play a role in safeguarding equity in clinical trials.

OncLive^®: What inspired the creation of the ECOG-ACRIN Health Equity Committee?

Simon: This committee is long standing since before I started., but it has expanded since I started several years ago. The vision is to ensure health equity principles are embedded throughout the [health care] structure. ECOG-ACRIN is a clinical trial research group, and it is part of the National Cancer Institute clinical trials group, as well.

It is important in the conduct of clinical trials, given the history in this country, that we have equity embedded into everything we do in clinical trials.

What are the biggest unmet needs for underserved populations in cancer clinical trials?

First, making sure that researchers or the team members on a clinical trial understand who bears the brunt of disease they want to focus on, and who’s not getting access to the cutting-edge treatments in that particular cancer, for example.

The second part is connectivity. How do you get potential participants into a clinical trial, and then how do you [build] that trust? How do you make sure at the personal level or the community level that there is trust? Unfortunately, we’ve earned the distrust of many in the United States over the centuries of egregious maltreatment in research, science, and in the practice of medicine.

That is what our committee aims to push forward—making sure that the teams are on all on board with understanding how to design and conceptualize a clinical trial that has equity principles embedded in it, how to make sure there’s appropriate access to clinical trials for everybody who wants the opportunity, and to make sure at the [patient] level that there is enough knowledge, understanding, [and] awareness of the value of participating in clinical trials, and all of the ethics and protections that are in place for participants in clinical trials nowadays.

You are a consultant and an immediate former member of the US Preventive Services Task Force (USPSTF). What are the main priorities for that group?

The goals and objectives of the USPSTF are to create recommendations in preventive services [and] preventive treatments for the entire United States. [It’s] a spectacular opportunity to have methods and approaches that are consistent to review a particular screening recommendation, say, for cancer screening or preventive therapy, for the nation. But the data being included in that process need to be collected in a way that’s equitable, [which] means the trial itself [must have] equity principles embedded, as well.

Over the last few years, I have helped play a role in promoting antiracist approaches to the recommendation-making process. Grades A and B recommendations for the USPSTF translate to correlate to the base amount of coverage for health care services in this country. It is critical to make sure that the recommendation statements are for every person who is in the United States and not advantaging some and disadvantaging other populations.

In 2021, the USPSTF released a report on actions to transform the task force’s methods to mitigate systemic racism. Can you just detail what the findings of that report were and what came out of it?

It's important that we look under the hood of the care, and we examine all the processes every step of the way of the recommendation-making process. [It is important to recognize if there] is an opportunity for systemic racism to come in, or a bias of some sort. That [report] highlighted, how UPSTF systematically reviews every single process involved at a very intentional level, and [ensure we’re] asking the important questions: Is the study excluding certain populations that bear the brunt of the of this disease that we're trying to make a preventive screening for? If so, are there other data to help support it? Are there other approaches that we could do to help support, ensuring that we’re more inclusive in our recommendation making approach, such as modeling?

One of the recommendation statements that [was] most recently released that is an example of embedding health equity is the colorectal screening, where we reduced the age to 45 from 50. By modeling, you can see when that happens, you open up many more opportunities for black persons in the United States to get screened. This is appropriate because we know at the population level in this country that Black persons get colorectal cancer younger in age.

It’s an equity moment when you can reduce the age of screening to 45 for colorectal cancer. You end up including an entire population and help to advantage them with access to screening at the more appropriate age. As we know, early detection of cancer is critical in a cancer like colorectal cancer.

What advice do you give to other physicians and investigators who want to help address some of these disparities?

This is on all of us. Any person in the scientific and health care professional space or in the practice of public health, [are tasked with moving] forward in health equity in this country in everything, not just cancer. It’s critically important for cancer because there's so much morbidity and mortality that’s associated with cancers across many racial and ethnic minority populations, and other underrepresented or underserved populations. The opportunities are endless to make your impact in health equity from whatever standpoint you have in the health care, scientific, and public health practice space.