Conversations in Clinical Trial Disparities

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Welcome to ReachMD. This activity, entitled “Conversations in Clinical Trial Disparities” is provided by Prova Education.

Mr. Phillips: 
So my mother was on a line at the post office a few months ago and she ran into a friend of hers. And the purpose of her being on that line is to pick up some medication. And on that line, she was speaking to a buddy of hers about how the doctor that she sees is trying to get her on to some cholesterol medication and how she continues to push back. What came out of that discussion with her buddy on the line was, “Well, I take medication for my cholesterol, and my doctor really made a compelling argument to do so.” And my mother retorted by saying, “Well, every time that I try a medication, it doesn't work, and I don't feel good.”  And her buddy looked at her quizzically and said, “You know, when I take my medication, I find that I take it in the morning and I take it with food, and you ought to try it.” And there was a conversation on the line about, really, the importance of good health and eating well and all those types of things. That discussion really changed my mother's posture. It was the friend of hers, as well as the discussion in the community on this post office line, that encouraged my mother to go home and take that pill and try it. And she tried it with food, and she tried it earlier at a different time. And she's been on that medication ever since. 

So what was a critical learning to me is that physicians and other healthcare providers sometimes need help from other voices that are thought of as being trusted voices to really encourage people to really change their behavior, as well as maybe give things that they might have been resistant to, particularly medication, a new chance – a new chance, a new opportunity. So trusted messengers are good partners for patient health. 

Dr. Vega:
This is ReachMD, and I'm Dr. Charles Vega. 

Mr. Phillips: 
And my name is Lionel. Lionel Philips. I am the president and founder of a consulting firm called Inside Edge Consulting Group. It's a pleasure to be part of the program today.

Dr. Vega: 
Well, it's certainly a pleasure to have you, Lionel, and welcome everyone to this discussion. 

That's a very compelling story about your mother. And it's certainly not the first time I've heard a patient who did not accept my advice personally, but who talked to a family member, who talked to somebody in her church, somebody else in the community who convinced that person to try what I've been endeavoring to get on board for up to a year without much success. 

So it really exemplifies the importance of the messenger. And if you could delve a little bit more, Lionel, into that role and why is it important to healthcare in general, but also to clinical trials specifically? 

Mr. Phillips: 
I think that's a very, very critical point, because if we continue to do what we've done in the past, we're not going to create any change. And using trusted messengers, although may not be a novel concept, it's something that we don't really think of as being part of our everyday practice in medicine. So it is important to identify who that patient is speaking to outside of the physician's office. And sometimes, you know, that should be considered as part of the health strategy. 

So who are those trusted messengers that are often in Black and Latino communities? Well, as I already mentioned, sometimes friends and family members, caregivers are trusted messengers. But even beyond that, pastors or folks that are associated with mosque are trusted messengers. Health ministries are trusted messengers. Sometimes folks gather in community centers, and those community center leaders are trusted messengers. There's a lot of published data out there as well about barbershops and nail salons, where conversations happen in the community. And people pick up different topics and it's a compelling way for people to believe that – it's a believable conversation based on folks that look like them and sound like them. So trusted messengers can take different dimensions and different shapes and exist in different types of areas in a community. But again, going beyond the practice and looking at who those trusted messengers are, I think, is a critical part of medicine today because that's where you can have better compliance as well as better uptake in some of the messages that you're trying to deliver to your patients. 

Dr. Vega:
That's so true, and I completely agree with you. I think the power of the messenger became really clear to me many years ago during our very first inaugural group medical visit for diabetes in our clinic. So we had a group of about 15 patients with type 2 diabetes, and I was one of the facilitators along with our nurse educator. And we started with just general concerns, what's on your mind, as we've been trained to do. And a gentleman raised his hand, said, “Well, my doctor wants me to take insulin because my diabetes is out of control. But I don't want to take insulin. It's going to make me go blind,” which is a common fallacy in our community. Immediately, a woman across from him said, “No, it's not the insulin that's making you go blind; it's your diabetes. You should take the insulin, and it’ll actually help.” And within about 30 seconds, we saw the power of that messenger and the power of having peers and peer educators. And he went on insulin and did fantastic. And it was just a drop-the-mic moment. Like, I couldn't believe that this is exactly why we had group medical visits, and within 30 seconds, they had proven their value. And that's clinical care. And you know, when it comes to taking a new medication or maybe getting a test done, that's one thing where we're talking about our personal health. 

But clinical trials are a whole nother beast. And maybe we should understand a little bit more about why diversity in clinical trials is more important. I think that the public is largely unaware of this, and particularly communities of color, and even clinicians may be somewhat naïve to this issue. 

Lionel, can you describe that for us a little bit?  

Mr. Phillips: 
Certainly. So I know that in speaking to physicians, and we do a lot of advisory boards with doctors, when new data is presented, and in that clinical trial, at least the clinical trials that support the approval of that particular new medication, you have underrepresentation of Black and Latinos. And it's a challenge because, for many physicians, that is a significant part of their practices. And if you do not see that represented in the data, it's less compelling for you as a physician, we know this, as well as for patients because those patients are not part of that work. So it's very critical that the level of prevalence of disease is matched in that clinical trial. And that clinical trial is, hence, what is the data that allows for the drug to be registered and approved. It’s a lot more compelling to, when you're sitting across the table from a patient, to say that, “Yes, you were represented in this clinical trial, someone of your age, someone of your ethnicity, someone of your race, and someone that mirrors your circumstances within your community, your social-economic situation.”

So clinical trials that are representative is critical, and I know that there are a number of pharmaceutical companies and other healthcare providers that are really driving toward making sure that they’re doing a better job. So yeah, I would say, as physicians, that's an expectation that you should have of your drug makers, that they do have representation, so that as you're introducing new products into your practice, that you can say that that patient was reflected in that clinical trial. From discovery through phase 2 to phase 3, and in some cases phase 4, representation is helpful. And to enable that, it's important that patients hear and begin to develop the element of trust around clinical trials. And that's the link that I would say with community trusted messengers. 

So CROs [contract research organizations] as well as sites that exist in the community really need to engage those trusted messengers so that patients would want to be in those clinical trials. Those trials are then representative. And then when you begin prescribing those drugs, you can actually speak to the fact that the community was part of the work that brought this product to market. 

Dr. Vega:
Right, so what I’m hearing, and certainly what I understand, is that we're not only talking about a problem of mismatched data where the data from clinical trials doesn't match the patients I'm seeing in front of me every day in Santa Ana, California – my patient panel prefers to speak Spanish, 80% of them – but it also can foster even more mistrust of the health system, which is a huge problem right now, particular during the COVID-19 pandemic. 

So I’m really interested to hear other ways that we can specifically try to encourage more participation, particularly in Black, Latinx communities, American Indian, Alaskan Native communities, in clinical trials to reduce these disparities. How can we make progress in this area? 

Mr. Phillips: 
I think that it's important to understand what does success look like? So understanding what the prevalence of disease is and make sure that we set up our trials so that the access is reasonable and that we're able to meet those goals, particularly here in the US. 

Now when I refer to trusted messengers, there are a lot of different types of trusted messengers. One that I didn't mention so far is independent or retail pharmacies. Many patients, after they hear from you as physicians, they fulfill those prescriptions or they go to a learned intermediary being the retail pharmacist. Well, imagine a pharmacist beginning to push information out into the community around just general awareness around clinical trials. Or if there's a particular clinical trial that's being activated in the community, there's then information on what that clinical trial is, why it's important that one be engaged in that clinical trial be pushed out into the community. You can do that through email. You can do that through things that are stapled onto bags, brochures, lots of different things that a retail pharmacist, and independent pharmacists in particular, can be doing at a community level. 

So lots of different strategies that can be employed to really begin to melt the challenges around trust. We note Tuskegee, certainly, is representative if not in a very literal way, in a figurative way in people's minds as the reasons why not to get into clinical trials, but they can be melted away by trusted messengers. And I would suggest that retail pharmacists can be very helpful to that end as well. 

So as we think of the community physician, we know that the community physician has practices in rural areas and urban areas, and that, truly, at the end of the day, is the patient population that should be reflected in clinical trials. So for those of you that are community doctors, having Black and Latinos in clinical trials is critical. But all patients should be fully represented in clinical trials, from whatever community that one is from. Because at the end of the day, you do want to make sure that as there's new drugs that come out, that the conversation is inclusiveness, that folks from rural communities and urban communities, Blacks, White, Latinos, are all represented. Women, as well, are represented in the portfolio of that registered trial, as well as, at the end of the day, the package insert that really defines how the trial was done and why is the drug on the market. So that is certainly something that is important. So community physicians is a critical part of this journey and a part of this work. 

Dr. Vega:
Those are outstanding points, and I concur. And I would also add that, particularly at community health centers [CHCs], which is really the only place I’ve worked, are great grounds for clinical trials, because automatically, they are ingrained in the community. That's part of what they do. And generally, they're going to serve a more poor and more diverse patient population. So it is the group that we don't see enough of in clinical trials. So CHCs are very busy. I know that extremely well. But to try to at least have the ability to refer patients on to clinical trials is a really important step for that clinic, that community, and those patients as well.

And I love the idea of partnerships and trusted messengers. This is certainly not something that only one group, whether it's pharma or pharmacies or faith-based organizations, can solve on their own. It takes a coordinated effort. 

And you haven't really talked about the role that clinicians, the average folks who are seeing patients every day, what role can we play? Maybe this is a good thing to close on is what are our action items when it comes to increasing diversity in clinical trials? 

Mr. Phillips: 
So I think it's so important for clinicians to look at becoming trialists, particularly those that are in underrepresented communities. That's one thing that would be tremendously of use. 

And then also, as these trials become available in the community, please work to enable a referral to a clinical trial site or have some working relationship with those sites to really allow your patients to be involved in clinical trials. So rethink the way that we're currently behaving or operating when it comes down to clinical trials so that our patients can be better represented in the final data that is used for registration of medications so that at the end of the day, we have trials that are done that are reflective of the population and medications that are based on science that’s reflective of the populations in which we serve. 

Dr. Vega:
That’s outstanding, and that’s a really strong close to our program. Unfortunately, that's all the time that we have today. So I want to thank our audience for listening in, and of course, I want to thank you, Lionel, for joining me and for sharing all of your valuable insights and expertise. It was truly a pleasure speaking with you today. 

Mr. Phillips: 
Thank you so much for the opportunity. It was my pleasure. Glad to be able to contribute to this important information. 

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