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Improving Diversity in Multiple Myeloma Clinical Trials With Craig Cole, MD

At the recent American Society of Hematology (ASH) Annual Meeting, Craig Cole, MD, Assistant Professor at Karmanos Cancer Institute, sat down with Oncology Data Advisor to share his passion for improving diversity in multiple myeloma clinical trials. He discusses the efforts that are currently underway to increase diverse accrual and the importance of raising awareness in order to address this issue both within the community and on a global scale.  

Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, we're here live at the ASH Annual Meeting, and I'm joined by Dr. Craig Cole. Thanks much for coming on today.

Craig Cole, MD: Oh, thank you for inviting me.

Oncology Data Advisor: To start off, would you like to introduce yourself and share what your work focuses on?

Dr. Cole: Yes, my name is Craig Cole, and I'm from Michigan State University's Karmanos Cancer Institute in Lansing, Michigan. My focus is in multiple myeloma, specifically in health care disparities in multiple myeloma.

Oncology Data Advisor: Just last week you were a faculty member for our Multiple Myeloma Task Force panel, which was an awesome conversation with six peers in the field. We're talking a little bit about this topic as well today, and one of the sessions presented here at ASH on Race and Science: Bench to Bedside to the Community. So, for a little bit of background, what are some of the challenges surrounding diverse accrual to clinical trials?

Dr. Cole: For decades—almost a century—there have been significant disparities in medicine between races, specifically in the United States between African Americans and Caucasians. These were exacerbated by the Flexner Report in 1910, which really segregated health care in the United States. That has especially been perpetuated into multiple myeloma, where we've seen clinical trials that have primarily enrolled Caucasians and people of European descent.

The FDA has done several analyses looking at the number of people of different ethnicities involved in clinical trials. Overall, worldwide, the number of people of African descent and Blacks in clinical trials has been about 4.5%. For other races and people over the age of 85, it's even lower than 4%. We know that in the United States, the number of people of African descent with multiple myeloma is about 20% of the myeloma population. Therefore, there's a great disparity between that 4.5% of Black people involved in trials and 20% of the overall population.

Oncology Data Advisor: Are there efforts underway now to increase more diverse accrual and bridge this gap?

Dr. Cole: I's been an incredible five years, and it's been an incredible meeting here. There have been incredible efforts that have really tried to bridge that gap to improve enrollment and make the enrollment in clinical trials more diverse. A lot of it started when the FDA, the American Association for Cancer Research (AACR), and the National Cancer Institute (NCI) noticed that there was this gap. They then had a meeting in 2020 to try and come up with solutions.

That then resulted in a paper that really assisted and set the groundwork for making trials more diverse by coming up with diversity plans—reaching out in the community to discuss clinical trials, setting goals of accrual, and maintaining the accrual of different ethnicities into clinical trials. I think a big thing that happened was when the FDA, in April of 2022, put out their guidelines for increasing diversity in clinical trials. That document, as well as the ASH diversity in clinical trials document, really did give a clear explanation for how we can improve diversity—not only in myeloma clinical trials, but in clinical trials in cancer and in benign hematology overall.

Oncology Data Advisor: Absolutely. I think they talked yesterday in the session about the diversity plans that you mentioned, about how these are standard for phase 3 trials, but not for phase 1 and 2 trials—is there a reason behind this?

Dr. Cole: I think there are a couple things. One, we know that the meat of a lot of the recommendations that are put forth in registration trials are within phase 3 trials. The phase 3 trials accrue the highest number of patients, and phase 3 trials are where we've been failing the most. There was a study that was done a few years ago looking at Black enrollment in phase 1 trials, and that's low too, but the stakes are definitely much higher with higher-accruing trials. There are still a lot of concerns within the community about randomization in clinical trials. I think that if you can solve the problem of enrollment in phase 3 trials, that would then definitely filter down into improving the enrollment in phase 2 and phase 1 trials.

Oncology Data Advisor: That makes sense. You mentioned about the different levels where this is being addressed, from the community and up. How do we expand this conversation to a global scale?

Dr. Cole: That's such a good question. I think one of the big things is awareness that there needs to be greater awareness—not only speaking globally about Europe and in Asia, but awareness that there are diverse populations in our cities and in our universities and in our academic centers. We can definitely try and reach out to those communities.

Sometimes we fall into a lull of enrolling the same type of patients in clinical trials. In the United States and between the different diverse populations, there is an overarching culture that we share. In different parts of the world, sometimes there isn't an overarching culture between different ethnicities and races. There is an extra level of challenge in doing that, but I do think that with greater awareness, really using some of the things that we outlined in the United States, we can reach out to improve clinical trials globally.

Also, I think the FDA is really asking for that—for not only trials in the United States, but on a global scale, because we've been doing the same thing for decades. For years and years and years, the way we've been enrolling trials has been the same. With inclusion and exclusion criteria in recruitment of clinical trials, we've been doing the same thing for years. It's exciting to see that there is a flex point that is actually happening right now where people are examining this—not cutting and pasting from prior clinical trials, but actually redesigning clinical trials to be more inclusive. People are looking at, does this neutrophil count criteria need to be what it is? Does anemia need to be what it is? Instead of having inclusion and exclusion criteria in the design of clinical trials to benefit investigators, it really does work to try to benefit patients. This will make it easier to enroll patients, to have a wider group of patients who are recruited into the clinical trial, and to make the clinical trials more accessible to more people.

Oncology Data Advisor: Absolutely, accessibility is the key as well. Awesome. Anything else you would like to mention about your work in this field, or maybe other conversations or other sessions at ASH that pertaining to this topic?

Dr. Cole: There have been a couple meetings at ASH, and I give ASH a lot of credit in having two sessions that discuss disparities in multiple myeloma. The conversations within those sessions are really inspiring. Again, I think that we just need to reach out to more people and have more awareness—not only in myeloma, but in hematology in total, because these issues aren't just confined to myeloma. It's easy to see it in myeloma because of the differences in incidence of the disease, but these are global issues across hematology. Age, gender, and race are all issues in enrollment to clinical trials.

It's just like what I tell my fellows. When you read a paper about a new therapy and you look at the patient across from you, if the patient across from you doesn't come close to the patients enrolled in that trial, you cannot trust that the results of that trial will translate to that patient. The effort really should be that we enroll diverse populations of age, race, gender, and ethnicity so that not only do we have equal representation, but we can have confidence that these new therapies, which are breathtaking, will work for everyone.

Oncology Data Advisor: Absolutely. Thank you so much for stopping by to talk about this today and for your work in this field and helping to raise awareness. We really appreciate it.

Dr. Cole: Thanks for being part of the solution and helping to raise awareness. I greatly appreciate it. The more that we talk about it, the more people feel comfortable with it, and the more that we can push things forward and cure some of these cancers permanently.

About Dr. Cole

Craig Cole, MD, is an Assistant Professor in the Division of Hematology and Oncology at Karmanos Cancer Institute in Lansing, Michigan. He specializes in the treatment of multiple myeloma, non-Hodgkin lymphoma, and myelodysplasia. He has published numerous studies and has presented his work at several large national conferences. Dr. Cole is dedicated to emphasizing patient empowerment and reducing disparities in hematology trials and care, and he works in collaboration with several local and national patient advocacy associations.

For More Information

Nemeth E, Walker AR & Barrett NJ (2023). Special scientific session on race and science: bench to bedside to the community. Presented at: 2023 American Society of Hematology Annual Meeting. Available at: https://ash.confex.com/ash/2023/webprogram/Session24154.html

US Food & Drug Administration (2022). Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials: guidance for industry. Available at: https://www.fda.gov/media/157635/download

American Society of Hematology (2021). ASH statement addressing diversity, equity, and inclusion in hematology research, practice and training. Available at: https://www.hematology.org/advocacy/policy-news-statements-testimony-and-correspondence/policy-statements/2021/ash-statement-addressing-diversity-equity-and-inclusion-in-hematology-research-practice-and-training

Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor. 


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