Advarra CEO Discusses Implementing Technology in Diverse Clinical Trials

ACT: It seems like AI is on everyone’s mind currently. How can AI along with some of the latest technology in clinical trials be used to identify diverse patient populations?

Saroony: I think it is revolutionary, and I think it’s going to change many industries. But I also think it's going to take time. To say that today, you apply AI and tomorrow you have a more diverse participant pool in clinical trials is a stretch. Having said that, I think there are a few things that AI can help one do. First and foremost, how do you leverage AI? Calling through all this data, calling through the EMR data, and identifying the patient population, identifying signals that say, this population this treatment is less effective for but this other population it is more effective for. I think leveraging AI to call through the data and identify one, the population and two, what trial they would be most appropriate for and three, actually goes as far as saying, what in the clinical trial made it burdensome for participants to participate? This means that any clinical trial that had these three procedures in it which added no value, but we can see that these three procedures actually meant that there were many fewer participants. Therefore, maybe we don’t need these three procedures. I think AI has a role, I think machine learning has a role, but I also caution people to understand that at the end of the day, there's still a lot of work to be done there. Data is one thing, but there are actually bigger obstacles to just identifying the patient to increase diversity. I think it's a misnomer to say you don't know who the patient is or where the patient is or the subject. That's why you don't have participation at the degree that you want.

I think there are other bigger problems. For example, there's a lack of trust by certain populations in the whole clinical trial process. There's lack of accessibility to clinical trials. What do I mean by that? If you think about where the vast majority of clinical trials are being held, they're not being held in community centers where you have a large, diverse, underrepresented population. So, how do you actually make trials more accessible by reaching out to sites that may be naive sites mean, they've never done a trial before? Or maybe maybe they're somewhat experienced sites, but there's sites in the communities where you want to attract the patients. For that to happen, you need to have sites that have the right technology to capture the data to conduct a trial, you need to have sites that have the right technology to capture the data to conduct a trial, and you need to have sites that actually conduct a trial through leadership, whether it's the investigator, whether it’s the site coordinator, who can relate to the population they’re treating. I think that that's really a bigger hurdle than identifying the population.

The other piece I would say is, we have to get to a place where the folks are conducting clinical trials that more closely resemble the participants that we want in the clinical trials. One of the things that we’re looking at right now is work with HBCUs to help train their staff so they are not just great physicians, but they also are great investigators and great coordinators of clinical trials. We're working to give them the HBCUs' technology so they can actually conduct clinical trials in their communities with the patients that are already seeing. To me, make it accessible, make yourself much more trustworthy. I don’t know if there is one sort of magic bullet that solves this whole thing. Many constituencies have to take the lead. Sponsors have to be much more thoughtful in the protocol design, much more thoughtful on and much more daring in terms of going to sites that they haven't gone to before. Look, the biggest chance of clinical trials is recruiting patients. So, what do you do? You go to sites to recruit patients. Well, you have to be daring and say, I'm going to go to the sites that haven't shown me in the past, I can recruit patients, but I'm going to help them be able to recruit patients because they're in the centers of the patients that I want to have in my trials. Those are the types of things that I think need to happen much more.

ACT: Looking forward to the remainder of the new year, what do you think industry needs to focus on the most to improve diversity in trials?

Saroony: I really think it's awareness and it’s awareness at the local level, it's not awareness by having a sort of DE&I statement on their website. It’s by actually going into the community centers and teaching, educating, sharing the benefits, and showing the process, the rigor that goes behind clinical trials. But t's not always been done the right way, not always been done the ethical way. This is one of the reasons Advarra exists, to make sure that these things are done in an ethical way, done the right way. I think what has to happen is going to the communities, go into the underrepresented centers, and share with them how clinical trials are conducted, why they're so important, how it evolved over the years from being an unethical venture, to an ethical one.

I will also tell you that going to the community doesn't mean putting a billboard up. Going into the community means engage with the influencers and the stakeholders in the community. It's not just the doctors and the nurses, but it’s also the church leaders and the community center leaders. I think this is what pharma needs to do more of, it needs to really engage directly in the communities if we wanted to increase the diversity. I think the same applies to sites and the same applies to the regulatory authorities. They all have that wall. So to me, that's the low hanging fruit.