‘Knowledge is Power’: Advocating for More Representation in Cancer-Related Clinical Trials

Although cancer outcomes have improved across patient populations in recent years, racial disparities remain.

There are a variety of reasons as to why disparities exist when it comes to cancer outcomes in minority populations, according to experts. More recently, attention has been placed on clinical trial access and the lack of minority representation in clinical trials.

READ MORE: Cancer Sees Color: Investigating Racial Disparities in Cancer Care

Recently, during the DONNA Foundation’s How to be Fearless Virtual Seminar, Melissa Gonzales of Genentech; Dr. Pooja Advani of Mayo Clinic; and triple-negative breast cancer survivor Carmen Reynolds discussed understanding clinical trials in the context of health equity.

Question: Dr. Advani, how do you see health equity?

Advani: I really like the definition of health equity that is posed by the (Centers for Disease Control and Prevention), which defines it as health equity being achieved when every person has the opportunity to attain his or her full health potential. And no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances.

(W)hat health equity means in the context of clinical trials – is something that is near and dear to my heart, running and doing clinical trials here for our patients with breast cancer at Mayo Clinic. I think health equity in clinical trials may potentially serve as a metric of societal equality and access to health care while also allowing assessment of certain biologic differences that may determine differential efficacy and side effects of medications that we use for breast cancer for our patients.

Additionally, I think that health inequity may prevent certain population groups, such as minorities or vulnerable populations, from sharing the benefits of our scientific advances, and it can make the trial results less generalizable. Additionally, things like race and ethnicity, and associated genetic variation can also be an important determinant of drug metabolism and responses to treatments that we test in a clinical trial.

Question:As a survivor, Carmen Reynolds, how do you define health equity?

Reynolds: Equity, to me, is sort of touching on what (Dr. Advani) said. It is about the equality and being the minority with the (triple-negative breast cancer) that I was initially diagnosed with. I am on my second round of cancer coming back right now. So, I did have to get out of the trial. But, just as (Dr. Advani) said, when I did get in the trial, it was not, to me, an equal trial.

You can't get a good trial because, depending on the disparities that you use, whether it be minorities, economic, financial status, and things like that, I think that plays a huge part on how well a trial can go and how much information or results that you can really get out of it. So, health equity to me should be more on an equality basis. If you don't have insurance, you should still be able to get in (a trial). And that doesn’t result in a good trial, if not enough people can get in it so that you can study them. And I see that that was part of a problem that there's not enough of the different types of minorities.

Question: The more the more diverse the pool of participants, the better outcomes for everyone. So, Melissa Gonzales, this is really your area of expertise. How do you define this concept?

Gonzales: At Genentech, we have an initiative called Advancing Inclusive Research. And this is to make sure that research is more inclusive. We should not be looking at the data and saying, “well, this only represents a segment of the population.” That's not inclusive of the patients we need to serve in this country. So, our mission is to make our trials more comprehensive, and more inclusive of all patient populations. And breast cancer is especially near and dear to my heart because I'm the daughter of a breast cancer survivor. And I realized that as a Latina, I want to be able to look at the data and say, “I know my risk. And I know that the scientists are studying this. And I'm confident in the data they're generating because I see a person like me in the trial results.

Question: Can you elaborate a little bit more about how the portfolio works at Genentech, some of the concrete steps that you're taking, and how you're seeing that actualized around the country?

Gonzales: When it comes to health equity, there are systemic barriers, there are barriers at the sponsor level that we need to address in our clinical studies and then there are barriers at the patient level. We want to make sure that we're being good corporate citizens and highlighting the needs that need to be addressed at the systemic level. Now, as a study sponsor, we have revamped our clinical development program to make sure that when we are designing trials, we're bringing patients (in) at the beginning of the trial and listening to the patient perspective, listening to advocacy perspective about what trials need to truly incorporate to make them more inclusive of patients.

We're (also) looking at the inclusion and exclusion criteria. Did you realize that for many years, inclusion and exclusion criteria have been based off of male Caucasian lab values? That's not comprehensive. So, we're addressing that. We also realize that there are out-of-pocket costs that could be preventing patients from participating. So, we're looking at addressing those and helping patients with things such as transportation (and) paying for parking.

And then of course, we need to raise awareness. Oftentimes, patients are not asked by sites to participate in clinical research, or the sites don't realize that there are trials available, and they just need to refer the patient to these. So, we're really trying to make sure our external partnerships continue to grow, to raise awareness. I don't want to be in a future when minority patients say, “Well, nobody ever mentioned a clinical trial to me.” We need to change that dialogue to know they're aware, and they understand the benefits of a clinical trial.

Question: Dr. Advani, one of your main areas of expertise is racial and ethnic disparities in breast cancer biology and treatment. Tell us a little bit more about your perspective of what's driving these disparities.

Advani: It's possible that we have these pre-identified barriers, socioeconomic factors, environmental factors, that can certainly influence disparities in our outcomes in breast cancer or other cancers. But as a lab-based clinician investigator, I also want to consider salient differences in disease biology. So, in this case, like cancer biology, African American patients have a higher mortality from breast cancer as compared to their Caucasian counterparts. So why is this difference there?

I think about it as a cancer biologist, is it because they have a higher incidence of triple-negative breast cancer that has been associated with more aggressive disease biology. Is it because they tend to be more resistant to standard therapies that we use for breast cancer, is it because they're more susceptible to micro metastases early in the disease course? I think these are very important questions to answer.

Clinical trials start in the laboratory. So, I think it's very important to have good representation right from the laboratory stage. One of my team's focus is to develop biomarkers for determining resistance and early micro metastases, specifically in African American patients, and also to design relevant models from breast cancer that has been derived from cells that have come from either African American patients or Hispanic patients so we can closely emulate in the laboratory, what we're actually seeing the clinic. We're truly going from bench to bedside in all spheres.

Question: We have to be focused on dismantling the old systems and opening them up for other kinds of people. Because it's not going to change on its own. We have to actively break down these old systems and these old barriers, and it's so difficult to do. And so, Carmen, as you've been listening to this conversation, can you share a little bit more about your experience, because I think it's a powerful story to share.

Reynolds: I was at first confused about how the trials went. But it's a huge educational piece for outsiders that No. 1, cannot afford the Mayo Clinic. A lot of (insurances) that other minorities have do not cover the Mayo Clinic. I got fortunate enough to be able to go there. At first, I was at another hospital. And then I got chosen to come to the Mayo Clinic for the trial. But that’s because I was searching for things. And No. 2, I was enlightened.

Once I was selected to be in the trial, I started to ask the questions. And then I was told, “Well, if you don't have insurance, you can't be in the trial.” Well, I wasn't told that in the initial invite. But now once I get into it, then here's the paperwork. And I'm sure it's over the doctors’ heads, where this initially comes from for a trial. But my question to them was, “Am I the only African American in this trial; my size, my weight, the way (the disease is) progressing or not progressing?”

They probably were surprised that I asked the question, but I'm thinking this. And moving through it, I said to them, “How can you get a good study, if I'm the only one?” And, so all the money that was being spent on this type of research, to have one or two (minorities) in there, to me is not a good trial. And I expressed that to them. Of course, everybody wants to do the research because that's exciting. I still (wanted) to be the lab rat. But in the end, when (the disease) came back for me, I had to get out of the trial because it's about the longevity of the trial. And I think in our country, right now, the trials are two, three, four or five years, which you can see thanks to COVID-19, it can be sooner.

So when (the disease) came back for me, and I had to get out of the trial, (my question was), “Which treatment was I on, because you have a placebo, and then you have a treatment. And you have to be on this for five years.” So, my question to them was, “How do I know if I was getting better from it?” And they said, “Well, if it comes back.”

I still don't know which one I got.

But to adequately get a good trial, you have to go out in the community. Because I think a lot of times now to get different minorities to come forward and go to different hospitals, (it’s important for them not to) be afraid of their situation, because (this is their) health, and they are scared. And again, they don't have the money.

I can understand why I was fortunate. Had I not had insurance, I wouldn't have been a candidate for the trial; when in actuality, I'm a perfect candidate for the trial. So, I don't know how the advocacy moving forward from things like this will be but it's going to be huge, because it's not a good trial with one or two different types of minorities in it adequately.

Question: Melissa, in blunt terms, that explains what barriers people are facing. What can people do to advance more inclusive research? How can patients out there make this a more pressing issue for the medical community?

Gonzales: I think all of Carmen's questions truly highlighted that if we are going to ask patients to enroll in clinical trials, they should have time to sit down with dedicated staff and ask the questions, “Will I know if I'm going to be unblinded? When will I find out that data? Who has access to my data? If I sign on this form, does this mean it gets sent to the government to explain to me the process?”

I think Carmen's question about “Well, how many patients that look like me are in this trial? How many patients with this type of breast cancer? How many black patients develop this type of cancer? Is that reflected in this trial?” We need to do a better job of sitting down and communicating with patients. And trials should reflect disease prevalence. For example, triple-negative breast cancer has a higher incidence in black women, then trials should aim to enroll more black patients. We need to empower patients to ask these questions, because that's how we're going to drive change. So that's why I love the title: “Knowledge is Power.” When patients have more knowledge, they feel like they're more in control of a situation that they didn't ask for.

Question: Dr. Advani, what are your thoughts about ways patients can empower themselves?

Advani: I really love what Carmen said. She was a fierce advocate for her health and for her right to participate in the clinical trials. And I would just continue encouraging the people that are listening to this talk that it is a privilege truly to be an advocate for yourself. I think that as a part of the medical community, we need to foster a better relationship with our patients and their family members to truly understand what barriers that particular patient is facing and how we can bring them on board for these very important clinical trials. I think that we have a lot of work to do from our end in the medical community, but I really appreciate Carmen and I hope several other patients like her just continue to be fierce advocates.

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*This virtual seminar was simulcasted on CURE®