BETA - What are some things that could be done to increase accrual of Black Americans in clinical trials?

How can we improve the accrual of African Americans in clinical trials in the United States? And I think the very first thing is making awareness that there is a problem. And I think that over the past two years, in the past five years, that really has come to fruition. I think that every myeloma doctor has an awareness that we are, and the FDA is now very aware that we have an accrual problem. The second thing is, it's also already happened, that we needed to really make sure that investigators an idea of how they're going to accrue people of different ethnicities and races in clinical trials. And the FDA in April of 2022 set up guidelines that every clinical trial that asks for a IND, which is the step before you open a clinical trial, has a diversity plan built into it, and that they know, the investigators know for the trial how many people of diverse populations need to be included in a clinical trial. They set a number. They then make that accrual goal of different ethnicities and races, and then have a plan to maintain that. So that is built into the clinical trial paradigm, that when you write a clinical trial, when you want it approved, because every clinical trial has to go through the FDA for an IND, that they review that. And when I've talked to folks at the FDA about how well will you enforce that, they say, well, it's part of the plan that you have to submit. So that's been achieved. So now the real question is, is how do we now we're ready for the boots on the ground? How are we going to get people actually of different ethnicities and races involved in these clinical trials? And I think the other part is awareness among the community, is having the community aware that they need to be involved in clinical trials. The perfect example, the perfect example of this is Revlimid and Velcade. We now know there was a paper that was published in 2021 that showed that people who are on Revlimid, black people on Revlimid, it causes darkening of the skin. So it makes their palms darker, it makes their souls darker. And it can be pretty distressing when you're taking a drug and then your palms turn dark. Revlimid came out in 2002, and it took us 20 years to see the side effect of Revlimid, for that to be reported. That is because when the Revlimid trials came out, that less than 5% of the people on those trials were African-American. 20 years to figure that out. Another paper that was published by the folks at Emory that showed that black people have higher risks of neuropathy with Velcade, that just came out in December of 2022. So it took us 21 years to know that Velcade has this neuropathy risk for people of African descent. And it's because of the lower cruel numbers. And I think that if the community saw that, you know, why do people go on clinical trials? It's for them to personally benefit and for it to benefit their community. We can now go to the communities of ethnicity and races and say, this is why you should be on the clinical trial. That we have that when people of diverse populations aren't on clinical trials, we miss efficacy, we miss side effects. Knowing that, because what would happen? You know, if we were to dial the, if I were to jump in the time machine and find this out there, I would have been able to do something for my patients with their neuropathy and their darkening of their skin. And so it's really important that we get the community involved in it. And then the other thing is to decentralize clinical trials. That right now we have what, about 24, 25 myeloma centers that accrue patients to clinical trials. And we know that people of different ethnicities and backgrounds, people of different social economic status, older people, don't engage these big myeloma centers. And so their efforts right now to try and decentralize clinical trials. Instead of the patient leaving their home, leaving their community to come to a big institution for a clinical trial, let's bring the clinical trial to them and make it at their doorstep and make it at the clinic that they're at. So every time that we talk about clinical trials and all the clinical trials we're talking about opening at Michigan State, we're trying to figure out how can we decentralize it away from the university and bring those clinical trials to the community. So this is on many levels a very complex problem. Especially let's say if we talk about just trials. Trial enrollment can be looked at from many facets and say, well yeah, there's many problems to tackle here. Is it about trust? Is it about historical injustices? And those are all relevant issues. But I think there's certain really easy low hanging fruit. When you speak to patients about enrollment in studies, ultimately, and this has been studied as well, ultimately people are people. If they trust you, if you trust your doctor, and if you're offering something that could actually benefit them, then in my experience patients don't say no. So I think one of the major things that we really need to do right now is say, look, there needs to be a minimum number of African American, Hispanic patients within the context of studies. They need to reflect our community if we're going to approve drugs. This is not a small thing. But how do we get those trials to people? We just need to open up in their community. So we need to open up trials where patients are seen. The truth is that many of these patients go to different hospitals. And that's for many reasons. That's financial. That's because of payers. That's also because of distance. So we need to make sure that we don't neglect entire segments of our community in terms of where we open up trials. I think very similar ideas go for rural communities where we have similar data that rural communities don't get access to many of these treatments. There's lower utility of things like, utilizations are of things like, of the stem cell transplant. So same deal for those communities. We need to make sure that we're opening trials at centers that serve those communities. So it's a big question. It's a very complex question. I think there is a lot to unpack there. But if we say that there are doctors that this community trusts, they should have access to those studies. And they will reliably put those patients on trial. I can guarantee you. There are several things being done to increase African-American accrual in clinical trials. Some of those include adjusting the eligibility criteria for clinical trials to ensure that we're not necessarily boxing out patients who may have renal insufficiency, which is more common in patients who have long-standing hypertension or long-standing diabetes. So some of these medications that we're using in clinical trials may not be significantly impacted by a lower renal function. And so that's one thing. There are certain hematologic conditions that are more common in African-Americans, including a lower neutrophil count. And that's a normal phenomenon in some of these populations. And so making sure that the clinical trials include that in the eligibility criteria. Some of these are being considered. And also ensuring that the informed consent is written in such language that is much more amenable and understanding to patients broadly, not just African-Americans, but most patients in general. So a diversity officer is more of a, it's somewhat of a business term in the sense that someone who is well-versed or knowledgeable about ensuring that there is broader inclusion of populations of individuals within a certain area. And so in a sense, yes, we do, it's an institutional decision about inclusion of a diversity officer. And I think that more and more people are inclined to do so because the reality is we need to highlight what it is that are the barriers to involving patients of all backgrounds in certain settings. And that includes the healthcare setting. And so having a diversity officer will help to highlight those barriers. And then you can act on areas that can be improved to allow for inclusion of patients of various backgrounds and increase African-American involvement in clinical care, clinical trials, et cetera.