The ever-expanding importance of diversity in clinical trials and drug development

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Claire Bonaci 

You're watching the Microsoft U.S. health and life sciences, confessions of health geeks podcast, a show that offers Industry Insight from the health geeks and data freaks of the US health and life sciences industry team. I'm your host, Claire Bonaci. For this podcast, I'm switching roles. I'll be interviewed by our producer Tracy Picon, on the importance of diversity and inclusion in pharma and life sciences, and specifically the importance of diversity in clinical trials.

 

Tracy Picon 

Hi, Claire, welcome to the confessions of health geeks podcast, as you know, but today you're in the hot seat, and I'm going to be the host.

 

Claire Bonaci 

Well, thank you, Tracy. I know it's very weird being on this side. But I'm excited. I'm excited to talk a little bit about pharma and clinical trials.

 

Tracy Picon 

Umm, I have a couple of questions for you. But I also want to prepare you for a rapid fire question session just a little bit, just a little bit. So you know, April is diversity month and we've been seeing the pharma conference, DIA  has been having a real focus on diversity, equity inclusion, you have worked in clinical trials and are an expert in this space in the pharma space. So in your words, how is diverse representation, or why is diverse representation so important? I guess, and also, what have you learned throughout COVID?

 

Claire Bonaci 

Yeah, well, definitely, I think this is something that is really, really important, especially just because of the lack of diversity in pharma, and in clinical trials. And just the history of that, I think, you know, as a whole, the industry has come a long way, but there's still a lot of way that they need to go. I think when it comes to even women and clinical trials after the Thalidomide situation in the 60s, the FDA basically excluded all women of childbearing age from early trials in the 70s. And obviously, we know that, you know, men, they do respond differently to medicines very similar to how people of different ethnicities respond different to medicine. So obviously, women will respond very differently as well. So this really posed a huge problem.  In the early 90s, actually, the FDA, they removed that ban from women on in clinical trials. But a recent report, I think, was a few years ago, the FDA released it, that women only represented around 43% of clinical trial participants globally. So clearly, it's still the ramifications from that decision are still kind of felt today. And obviously that results in women, and obviously, we have to assume minority populations as well, they're at a greater risk of having adverse events due to maybe just a lack of representation in those trials for the medications that they're taking. So obviously, I don't think it's a sex issue, in particular, I think it's more of a overall diversity problem within the industry, but also kind of within those trials in the industry, if trials are not conducted with people from all demographic and non-demographic characteristics, that includes sex, race, ethnicity, age, even patients with like organ dysfunction, or different comorbidities, then the industry as a whole, it's not serving the entire population equally. Obviously, that's the ultimate goal of every pharma company. And even from a business perspective, they're missing a large population of just people that could be buying or using their products if they're not making the medicine for everyone. And obviously, when it comes to COVID, everything had to stop, trials had to stop. And they really had to look at, Hey, can we serve rural populations? Can we serve patients that might not be able to come into the hospital every day? Obviously, I think people are very privileged that can, you know, drive 20 minutes to a hospital, but that's not the case globally. That's definitely not the case in the US everywhere. I think the pandemic kind of showed much more inequities, especially in clinical trials. And I think that's something that definitely the industry is kind of woken up to.

 

Tracy Picon 

do you think that will continue?

 

Claire Bonaci 

I do, I think the last 12 months of the pandemic, really expedited healthcare as a whole, probably more than in the last five or 10 years. That definitely happened in clinical trials that definitely happened in pharma. I think there's this like huge emphasis now on decentralized clinical trials and trying to make that available to everyone. So I do think it's probably going to continue. I mean, I hope it does.

 

Tracy Picon 

Right? For sure. I think, how do you serve the entire population, if you don't represent the entire population? How do you make choices for people? If you're if they're not a part of, you know, the entire program to start, right? How do we do that? We don't want to do that we shouldn't be doing that. So given you do have this expertise in clinical trials, right, this is where you spent the first part of your career. Why did you make the leap to a technology company? We all have our reasons for getting over into technology, whether it's scale or or you know, making a bigger impact, but what why did you make the leap to a technology company?

 

Claire Bonaci 

Yeah, well, definitely. I think you kind of hit the nail on the head there on scale, but but really, I did. I loved working on clinical trials. I loved working on a top pharma company. And I think realistically, if I was still there, I'd probably still love it. But the reason I decided to make that change to a tech company was really because I saw so many gaps in technology in the pharma and life science industry as a whole. It was, it was not just the problem within trials, or the trial data, or my company or my group, it really was a whole issue with industry. I mean, I think, you know, across every pharma company, there's so many disparate and legacy systems and the manual tracking of data that happens every day. And what I see when I say, data, I do mean like tons and tons of data, just everywhere, everything is data. And everything is generally done pretty manually, I think that was a huge gap and an opportunity for technology to kind of play a bigger role. And so obviously, I felt that maybe my direct experience in trials and pharma could somehow be leveraged to actually create solutions for the industry as a whole and like a more scalable way that can be implemented across the whole industry. So I really thought, you know, maybe I could make more of a difference than trying to do something just in my department, or just in my company. So that's kind of why I started looking outside of my company and trying to figure out like, how can I go to a tech company? How could I make a difference kind of on the industry as a whole?

 

Tracy Picon 

Yeah, I love that, because that's one of the reasons I came from med tech. And that was one of the reasons just seeing these gaps, gaps, where I thought technology was the impetus to changing and supporting all constituents, right. So the patient, the clinicians, the systems, this, you know, the C suites of all these health systems, the payer space. So we have talked about, you know, we're talking about equity. It's a it's a hot topic right now. And it has been for a long time, but I think we've seen lots of disparity in care over the last 12 months, it's really been highlighted. We've known it's been there, but it's been highlighted. How do clinical trials become more equitable? And then what's the role of technology? Like how do we, how do we bridge that gap with those in those two, with, with the technology,

 

Claire Bonaci 

I'll say what everyone has probably heard that diversity and inclusion, they need to be focused in every industry, especially in pharma and Life Sciences. But what I really mean by that is that diversity inclusion should be part of every pharma and life science companies company blueprint and plan as a whole. If it's not part of how the company operates daily within that company, it's probably going to not carry over to how trials are run. So especially if they're I know a lot of companies, they have given a yearly audits or internal audits are checks to ensure that they're kind of living up to their values. So I think if they're really making sure that diversity and inclusion is one of those values, and they're keeping up on it, then it's going to carry over into trials, I think it's important to kind of have that diverse workforce as well, at every management level, I think, especially in middle management, since that's where a lot of the like on the ground decisions are made for clinical operations, which typically run clinical trials. I think that would mean, you know, having more women and having more people from diverse backgrounds, whether that's race, or age, or sex, or neurocognitive diversity, I think having all people to be in those decision making positions, or even consulted about the decisions that they are making could really expand the amount of equitable clinical trials that are out there. And I think it also, you know, when it comes to increasing diversity just in trials, if you think about specifics, even just expanding eligibility criteria for trials, sometimes just the strictness of the eligibility has some kind of unconscious bias built into it automatically. Or even expanding the location of trials, like we talked about with decentralized files to make sure that people from rural or diverse locations can still be part of it, you can still get that data. And then of course, I think something that I always like doing was kind of working with the patient advocacy groups or community based clinics, since you do get a very diverse population there as well. So although that's not necessarily focused on technology, I think technology plays a part in all of those since, obviously, we see the work of you know, ethical AI coming into play, focusing on making sure that there's less bias. And then, of course, just the decentralized clinical trial methods of having remote patient monitoring, or having ways that all of this can be done almost from an iPhone or from an app to make it a little bit easier. So hopefully, technology plays a role in all of it. I think it's slow going currently.

 

Tracy Picon 

Yeah, I remember sitting in a room, listening to a speaker, and they were talking about the millions and millions and millions of pieces of paper. And it just struck me if you have to go through all of that manual process. The last thing that's going to be maybe on your mind is the diversity part, because you have to there's so much that you have to go through and support, whether it's through the FDA, you know, positioning and everything else is like so if you without the technology, how do you do that? Right? So maybe the technology will bring that visibility that we're all talking about right and be able to scrub the data so that you know like in real time what's happening.

 

Claire Bonaci 

Exactly. Hopefully we can Fingers crossed.

 

Tracy Picon 

fingers crossed. Yes. And I like that you talked about ease, right ease and then the general Working with the communities like, does that happen often? Or was that just one of your passions?

 

Claire Bonaci 

It happens sometimes. But I think it's harder, especially when trials are run globally. So for those larger trials, it's really hard to be able to know, okay, how do you do this in the Ukraine? Or how do you do this in other countries, so you really have to rely on other vendors or CROs, and really making sure that you have, you kind of have to go out of your way to be like, Hey, we need to assess and make sure that we're getting community hospitals involved, or community clinics, or advocacy groups, it's not something that you know, it's like built in, and it really does have to be kind of like, a check that you really make at the beginning before you start a trial. Unfortunately,

 

Tracy Picon 

I have so many questions for you. We're going to do another podcast, maybe several more, because I have questions. I think we need to tackle things like fear. And and how do we support our communities, if there's a level of fear, so we have, we have more more to come for sure. But I want to get to the rapid fire questions. Okay. So, answer the first thing that pops in your head. I know, it's kind of neat, but let's do it. Okay. Name, your, in your vision, name, the root causes and barriers to inclusion in clinical trials?

 

Claire Bonaci 

Well, I,I feel like the first one would probably be racism. An obvious one. I think another one is probably like language barriers. Since we saw that, and just like global trials, and then probably just like socio economic constraints, or like, just, you know, the overall kind of language barriers or communication barriers with different populations.

 

Tracy Picon 

Yeah. Yeah, no, this is good. Okay, favorite thing about working in clinical trials,

 

Claire Bonaci 

Ooh! I think probably designing the protocols, specifically in different regions, I feel like it was really cool to kind of understand the different cultures of that region. I think it was really cool designing the ones in Japan because they just had such a different way of doing things. And, you know, making sure that you always had to do things out of respect, like it was, it was so cool to learn about. So it really although I was designing protocols, it was more Oh, I'm learning about this Japanese culture, which I thought was super fun.

 

Tracy Picon 

That sounds awesome. Okay, favorite part of designing those protocols. Besides the culture aspect?

 

Claire Bonaci 

Yeah, I'd probably say working with like the medical affairs teams and the doctors, because they were the experts. They were the most knowledgeable and passionate about those disease states that it was so kind of cool to see them so excited, and talking about these disease states that they were so passionate about solving. So I think that was kind of fun of, you know, being able to talk to these really high up doctors that knew so much more than I did, obviously.

 

Tracy Picon 

I love it. All right. Thank you so much, Claire. This has been great. I love that you're in the hot seat now because usually, Claire is our host of confessions of health geeks. And as I said, we're going to discuss we've got so much more to discuss. So definitely tune in for the next episodes of, I don't know, should it be Confessions of Health Geeks Pharma edition?

 

Claire Bonaci 

I love it. Exactly.

 

Tracy Picon 

Alright, thanks, everyone. Have a good day.

 

Claire Bonaci 

Thank you. Thank you all for watching. Please feel free to leave us questions or comments below. And check back soon for more content from the HLS industry team.

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