Diversity in Clinical Trial Enrollment in Key Oncology Trials: Are We There Yet?

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," …