During DIA Global in Boston last month, (June 2023), OSP caught up with Curavit’s president Dave Hanaman and chief commercial officer and Natalia Husby, business development manager. The company has been working with underrepresented groups in clinical trials for some time – and before the FDA issued guidance on inclusivity.
We discussed the meaning of diversity, how these groups can be reached and finetuning the balance between patients, science, and business.
OSP: Can you give me a bit of background on the company and an overview of what you do?
DH: We started Curavit just before the pandemic, launching the company in January 2020 with a focus on virtual or decentralized or digital clinical trials. One of the fundamental advantages of these novel trial designs is that they can recruit from populations that have typically never been available to clinical trials.
I think the statistic is 97% of the people who could participate in a clinical trial are never exposed to one or even aware of it, yet let alone able to enrol. The very premise of our company getting into virtual clinical trials sits on top of this fundamental advantage of decentralized trials, which gives access to these very diverse populations, whether you're talking about Native Americans in the four corner states, rural farmers in Appalachia or the inner-city single mothers. So, gaining access to those populations is part and parcel of what we do as a company.
Fast forward to a couple of years ago, the FDA started to provide specific guidance on this, and we were paying attention. Everybody wants to do the right thing morally and for science and it's the right thing for the business.
OSP: Do you think this guidance will be taken on board?
DH: This is bigger than just the pharma industry. This whole idea of diversity is across the board in a lot of different industries.
What I think is unique about the pharma industry is that diversity is essentially good for business – meaning we can support it, not just because it's the right thing to do, but because it's the right thing for the science and the right thing for the business.
In terms of commercialization, there's everything from access to market and diverse markets, where you can sell your products more widely. In addition, there is a health economics aspect to it and a lot of issues that disproportionately affect different groups in that diversity spectrum – whether it's race, culture, gender, geographic access, or socio-economic ability. There are all sorts of maladies that disproportionately affect groups within that spectrum. By getting the data right, you're doing the right thing for science.
OSP: Could you outline your role, Natalia, what you do for trial sponsors and exactly how you help?
NLH: I've been helping our operations team working on this idea. There are six components to it but it's really whatever the sponsors need and how we can help in terms of planning using the diversity plan. This includes identifying potential populations that they may want to focus on when recruiting for the specific disease that they're studying. Then we figure out some good partners that they should work with, depending on what their specific needs are.
I’ve been connecting with partners specialised in outreach and engagement with specific communities. I also get involved with helping evaluate protocols for potential design issues that could be a barrier for some people to participate that the sponsors might not have been aware of.
So, evaluating protocols as well as understanding the messaging and content. Looking at brochures or a website where a patient might learn more about the potential trial. I see whether there is information on there that might be not easily digestible for people of different health literacy backgrounds or different cultural backgrounds or language barriers.
I also provide dashboard updates for sponsors to check on enrolment and patient engagement, so can mitigate or optimize the situation.
OSP: So what would you say the most underrepresented groups were in the US?
NLH: I think it can vary by disease state and site location. So, another thing we do is look at certain sites a sponsor has already selected. We want to look at the populations within those sites and see if there's a diverse population or not. If there's under representation of a specific group, we start looking at alternative sites or other ways to recruit people. I would say it can vary, but I think people who have indigenous backgrounds, specifically because there's already a bit of distrust with the government in general, and a distrust with the medical system for obvious and good reasons.
It is a challenging population to reach but will only get better with continued engagement and not just saying, ‘hey, you're underrepresented, but we need you in this study’, because then it becomes transactional.
OSP: It's good point. So, who reaches out to these patients? How are they linked up?
NLH: What we're doing right now is establishing partnerships with different organisations and understanding how their methods might be different and how they can access different populations. Some of those organisations will engage directly with communities.
Different organisations have different strategies but it’s a really cool place to be because you're learning about so many different ways to reach out to people and help improve their health. It’s exciting to see the creativity of people trying to figure out how to solve this issue because there's so many different potential avenues, but we don't yet know the best strategy or answer – but it’s exciting to be involved in it.
OSP: I suppose there must be some sort of incentive to keep people motivated and retained on trials?
DH: Depending on who you're trying to recruit and why, it's fairly complex. Patient recruitment has always been the hardest thing in clinical trials and the diversity component just makes that more complex. Like the advertising industry, we go through many channels to reach different targets, we're no different.
We almost always have what I would call a belt and suspenders approach, which is – you don't want to rely on any one channel. To get everybody you need from a certain subset, you have to cast a wide net and we are working with a variety of community groups, churches – you name it. It does sound interesting but it's a tough gig. It's hard.
OSP: Do you think you'll see kind of lots of other people trying to concentrate on this now that the FDA have issued draft guidance on it? Do you think people will tackle it themselves or they will use companies like Curavit?
DH: Others will do what we're doing, certainly the CROs. We will all have ways of doing that, especially the big CROs. We are in a very unique space in the area of these novel, virtual decentralized digital clinical trials.
Our approach is also a novel approach that lines up very nicely with the type of trials that we run in the therapeutic areas that we're in, and the type of sponsors that we work with. This is not to suggest that the big CROs won't have good solutions - they will but they tend to be involved in totally different types of trial, or they tend to be very good at a different type of trial than us.
OSP: How receptive have people been? Has there been any cynicism, or has it all been well received?
NLH: I don't think anybody's against it. I think they're more cautious when they first start talking to you to see what the intention is. When they get to know us and understand where we're coming from and realise, we're doing this because we care and because it's important, they are a lot more open and willing to engage with us.
DH: It's always important to remember that the whole concept of drug research and clinical trials is, at its base, an agreement between the participant in the trial and the company doing the research.
You're looking to prove safety and efficacy in clinical trials. The idea of truly informed consent is important, because we're not saying we want to provide therapy that we know is safe and effective - we're just asking you to be a recipient of it. It's a contract that says you are acknowledging the risks and the opportunities. You are participating of your own free will and people are motivated to be in clinical research because of the greater good that it serves.
It's not just a one-way ‘we're here to help you’ street it's a two-way street where they are acknowledging the risks. Part of the reward is doing the right thing to help themselves potentially, but also to help maybe family members that may end up with the same genetic disease that they have, or people in their community that are hit harder by this particular disease than others. That is a really important thing on the clinical trials side to keep in mind, is it's a two-way street and you not only want them to know that you care about them, but you want them to also be fully informed and doing it for the right reasons.