So my name is Craig Cole and I am from Carmanos Cancer Institute in Detroit and Carmanos Cancer Institute in Lansing, Michigan. So I'm actually going to be talking about bispecifics and minority populations as well as talking about enrollment of blacks and other ethnicities in clinical trials. One thing that we know is that the number of blacks in the United States with myeloma is about 20 percent. But the FDA looked at their data of registration trials and there's only one to five percent of blacks actually on the trials that approve the drugs that we use to treat the disease. Despite there being eight percent Hispanics and Latinos in the United States, it's more like one to two percent are involved in those clinical trials. And if clinical trials aren't inclusive, if they don't include lots of different types of patients of different ages, different races, different ethnicities, making sure that we have women on those trials as well as men, then how can you know that these drugs will work across the board? And so one thing that I'm going to talk about is the problem of not having enough people enrolled in clinical trials, black people and brown people enrolled in clinical trials. And a lot of that responsibility lies with us. That the FDA looked at inclusion and exclusion criteria for clinical trials, why people get in and get out of clinical trials or excluded from clinical trials. Blacks and Latinos were more likely to be excluded from clinical trials than whites because of how we wrote the trials. We didn't write the trials to be inclusive, specifically making sure that we change the blood counts and change the hemoglobin and change the neutrophil count to accommodate more broad swaths of patients. Then the final thing I'm going to talk about are solutions. How do we solve the problem? And one way we solved the problem again is making the clinical trials written so they can include more people. Also putting the clinical trials in the community. A lot of people don't go to academic centers or can't afford to go to academic centers for their myeloma care. So what if we can, instead of doing a myeloma trial at one of the big academic centers, which have been doing for hundreds of tens and twenties of years, why not move that into the community, right where people live. And therefore they can afford to go, they can afford to be on clinical trials and be included on clinical trials. I think one of the most important things is to include patients in the design and the implementation of clinical trials. To make clinical trials easy for patients. Just the FDA, just a few days ago, actually published guidance of how we can decentralize clinical trials and make it easier for patients to go on those trials. Because the only way that we're going to cure myeloma is to do clinical trials to make sure that the drugs work for everyone.
HealthTree • October 8, 2024