Show notes
Dr. Chino welcomes Dr. Jennifer Miller and breast cancer survivor Megan-Claire Chase to discuss Dr. Miller's recent OP article, "Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for U.S. Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time," highlighting new research about how we are doing with diversity in key cancer clinical trials TRANSCRIPT Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an associate professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. There are known problems in enrolling a representative sample on cancer clinical trials, with stark disparities within certain demographic groups, including age, sex, and race and ethnicity. Patients who are female, non-White, and at the age extremes, either younger or older, are known to be less likely to participate. With skewed patient participation, the validity of randomized data may be questioned, with some asking whether clinical trial results based on a charmed enrollment sample can truly be applied in routine practice. I'm happy to welcome two guests today to discuss new research highlighting how we are doing with diversity in key cancer clinical trials. Dr. Jennifer Miller, is Co-Director of the Program for Biomedical Ethics and an associate professor at Yale School of Medicine. Her research focuses on ethics, equity, and governance in research, development, and accessibility, as well as in the ethics of healthcare data sharing. She is the first author of the manuscript, "Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012 to 2021: Bright Spot Trials and Trends Over Time," which is featured in JCO OP's March print issue. Megan-Claire Chase is a 10-year breast cancer survivor, patient advocate, and a current program director at SHARE Cancer Support, a national nonprofit that provides free education, assistance, and navigation services for people with breast and gynecological cancers. Since her treatment for stage 2A lobular cancer, she has worked to fill the gap of knowledge and advocacy for young patients with cancer, including through her blog, Life on the Cancer Train, and through the podcast, Our BC Life. Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today. Jen and Megan-Claire, it's really nice to speak to you today. Dr. Jennifer Miller: Thank you for having us. Megan-Claire Chase: Thank you. Dr. Fumiko Chino: Jen, before we dig into the specific research, do you mind giving us a little bit of background about your work in bioethics and what led you to start this specific work on clinical trial diversity? Dr. Jennifer Miller: Yes, thank you so much. So, as you mentioned, I'm the Director of Bioethics for Yale School of Medicine and a professor of internal medicine at Yale. And then also in 2005, I co-founded a nonprofit called Bioethics International and direct a project called the Good Pharma Scorecard. In all of those roles, I'm focused on one big question: How can we help the 7 billion people around the world live a good life, a flourishing life? And in order to even talk about that bigger concept, we need to think about some basic things: access to clean water, housing, food, education, among other things, and a level of health. And there are so many determinants of health, but one of them is access to medicines and vaccines. And when you think about access to medicines, you have to think about the role of the pharmaceutical industry, given that it sponsors 75 to 90% conservatively of the clinical research supporting FDA approval of our new medical products. What's interesting is while the industry has a very stated noble mission, right, to 'cure, heal, and advance people's health', when you survey Americans in particular, 91% think that companies put profits before people and patients, so money before people and patients. And when you look at the media and the court cases, they're covering mostly scandals and outright ethics failures ranging from concerns about whether companies are telling you the truth about the safety and efficacy of new medicines and vaccines and worries about outright price gouging. And what's interesting is when I host a meeting every year with C-level executives from pharma, when I get them together and show them all of the concerns that stakeholders have about their patient centricity, I often hear the same two things: one, "Those are old issues that we fixed. If only you academics looked at more up-to-date data, you'd see that that is no longer a problem," right? And so they called the pricing problem a 'hoodie' problem because Martin Shkreli, he wore a hood, a black sweatshirt with a hood. But as we know, there's a widespread current and genuine pricing problem with medicines and vaccines. And then they said it was an outlier company, right? "That's one company in an otherwise sound industry or rogue employee in an otherwise good company, not the industry as a whole." And so when I walked away it's, wow, there's a black box. We actually don't know the ethical or patient centricity performance of pharma companies, of an individual company, of a product, of a trial, or of the whole industry as a whole, and it's really important to know this. And so, I got together a multi-stakeholder group and I said, "Hey, fine, I'm neutral. It's either a misperception, you're doing great and we need to build merited trust, or there really are some problems and we need to fix them and get them right for patients around the world." That's how I started the Good Pharma Scorecard, which is really designed to set ethics goals for the pharmaceutical industry and turn them into metrics so we can benchmark the performance of trials, products, and companies and then rate and rank them. What that does is it recognizes where there are good practices so we can study how they did it, but importantly to catalyze reform and change where needed for patients. We started by looking at the transparency of clinical research, right: do pharma companies tell you all the safety and efficacy data about new medicines and vaccines? And we were able to measurably move the needle. In other words, pharma companies really changed their practices as a result of getting their Good Pharma Scorecard ratings and rankings. And so we turned our attention and said, "What else should we tackle?" And the next thing we tackled was representation in clinical trial enrollment, for exactly the problem that you mentioned. We tend to test our new medicines on healthy, young, White males that don't represent the patient population in the US or other countries who end up taking products post FDA approval. Dr. Fumiko Chino: What a great narrative of how you kind of reached the point where you are doing this research. And again, I think you've highlighted that diversity in clinical trials is only one aspect of everything that could potentially be improved in healthcare in the United States. So I am so excited about what you're going to do next to address the next issue. But let me ping over to Megan-Claire. I know a little bit about you personally, but can you share with our listeners a little bit about your background and just discussing for example, the multiple hats you wear in life? You have a cancer survivor, you're a cancer caregiver, you're a patient advocate, and obviously you work at SHARE. So what is your origin story for Warrior Megsie? Megan-Claire Chase: Well, first of all, I always knew I would get cancer, and when people hear that, they're like, "Why would you say that? Like, why would you even, like, mention that out into existence," right? But it's no, like, I know my family medical history, at least mainly on my mother's side. And I'm an IVF result. It took my parents 8 years to even get pregnant, and then during the third month, my mother was diagnosed with ovarian cancer. And so, I like to say I'm literally a cancer because I was born in July. I was born 3 months early. I was supposed to be born the last week of October, and I was born July 3rd. And so the joke in the family is, I look nothing like my mother externally, but internally, I got all the issues. And so we really are both walking miracles, the fact that we did both survive this, but I knew, I just knew I would get ovarian or cervical cancer because that's where all of my issues were. So I had been monitored since I was 16. And then, of course, having other health issues, being born premature and all of that, and then ultimately, I had very strange symptoms. We hear the guidelines of breast cancer, and I had none of those. But I also was an advocate. So in my family, my parents are divorced, so I'll mainly be talking about my mother's side. My maternal grandmother, my Nana, she was the first biracial registered nurse at St. Vincent's in Bridgeport, Connecticut. And my grandfather was a mortician, so we're like, "Boy, aren't they like the perfect couple, you know? She helped you in life, and he helped you in death." But all of that to say, I was raised to know my patient right to change doctors, my patient right to ask questions, and my patient right to get pushy. And I did all the things. So we often hear, "Hey, you need to advocate for yourself." Well, even when you advocate for yourself, sometimes you're ignored because I'm a woman, then I'm a Black woman, and then I was under 40. So I wasn't even old enough to get a mammogram. And because there is that correlation between breast and ovarian, I was able to get one early and covered by insurance 100%, and they were like, "Hey, you're good. Come back when you're 40." But I kept having all these other strange symptoms, and I just kept pushing and pushing for close to two and a half years, and then it wasn't until the cancer was like, "Okay, we're going to have to just make a grand entrance because no one's believing you." Then everyone sprung into action, and it was because of all that, and I thought to myself, "Oh my God, if I'm being ignored and I am someone who's pretty darn vocal, what if English wasn't my first language? What if I didn't know my family medical history?" Like, I just went down the rabbit hole, and my background is in media and marketing, and I'm also a writer. And so I was very open with my diagnosis because I'm an only child too. So this is like huge. It was just too big for me to deal with alone, but also I wanted to like amplify the barriers that I was experiencing and then also losing my fertility. I mean, it was just so many things at once, and it was through that, I ultimately realized, "Hmm, this cancer journey, it's never really over." And that was how I came up with the name "Life on the Cancer Train" because I was like, I keep waiting to get off the stop permanently, and that's not happening. And though I am now in double digits of 'no evidence of disease', I call it my boyfriend NED. We've been in a long-term relationship now for 10 years and we're going to continue going strong. I've had so many other issues that no one prepared me for. And so I was doing a lot of advocacy work while I was in media and marketing, and then I was like, "Hmm, what would happen if I actually worked in this space? Like, imagine what I could do." And that's ultimately how I ended up finally working at SHARE Cancer Support remotely because I live in Atlanta, Georgia, so you may hear a slight twang every so often. And I am the Breast Cancer Program Director and host of Our BC Life podcast. And, you know, through all of that, I am known in Cancerland as Warrior Megsie because my hair came back curly. And, you know, so many people are like, "Oh, I would have loved for my chemo to turn my hair curly," and I'm like, "Well, I wanted my hair." Every time I look at myself, it's traumatic. Yes, do I rock it? Sure. I mean, when it was coming in looking like a chia pet, I was a little concerned, but every day I'm reminded of what I've gone through and what I continue to go through. And that's ultimately how I made my grand entrance into Cancerland. Dr. Fumiko Chino: Thank you for sharing that with us, and I know that this is not kind of how you wanted to find your mission in life, right? You would have been much happier to just live your previous existence without cancer, or just being a cancer caregiver, or just being an advocate, or just being a communicator and not being a cancer survivor on top of all of that. So, I do appreciate though that you took it for what it was, which is this is the path that you're walking down, and so let's try to make that path better for everyone, more comfortable, clearer, more outlined. And so I appreciate that. Now, Jen, do you want to walk us through your actual JCO OP study, what you did, what you found, why it matters? Dr. Jennifer Miller: Sure. Second plug for St. Vincent's in Bridgeport. My mom works there as well on Nine North, so I was so excited to hear that, that common touchpoint. So when we added the representation challenge to the Good Pharma Scorecard, we, obviously unsurprisingly, found abysmal representation of a variety of different groups or pretty much everyone. And we stepped back and we said, "What more can we do to measurably move the needle?" Because there have been 40-plus years of policy efforts to try to improve representation of women, older adults, and racial and ethnic minoritized patients among other groups, and we haven't measurably moved the needle for any group in cancer over the last 10 years. And that's shocking not to see any improvement in 10 years. That's a lot of time and there's been a lot of investment on this issue. And so, what we settled on was this idea of doing a bright spot analysis. The bright spot approach assumes that somebody, somebody's getting it right, and if we could find that bright spot and study how they do it, we might be able to develop generalizable guidance for everyone else to be able to repeat that positive behavior. That bright spot analysis was done with the FDA Oncology Center for Excellence with their support. And so, while the 10-year data looked abysmal, right, we hadn't seen any improvements overall, when we started to look by sponsor, it turns out there were some bright spots. There were some sponsors who were able to consistently adequately represent one group. They couldn't represent everybody, but they were getting one group, right, and we decided to focus on Black or Latino identifying patients. And we found 33 bright spots. So I'll tell you the overall data and then I'll talk a little bit about the bright spots. So we looked at a 10-year sample, novel oncology products approved by the FDA between 2012 and 2021, which was 111 novel cancer therapies sponsored by 70 different companies based on 121 pivotal trials enrolling over 50,000 patients around the world. And what we found was zero trials, zero trials adequately represented all the demographics we were looking at, which was sex, age, and racial and ethnic identity. And we were comparing enrolled participants to the patie…
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