The COVID-19 pandemic created a significant shortage of suitable patients for clinical trials worldwide. Within this crisis was another more serious issue around inclusion and representation, driven by COVID’s disparate effect on certain ethnicities, that spoke to a wider issue of certain patient populations being unable to find or be invited into important trials for them. Proventa spoke to Liz Beatty, Chief Strategy Officer at Inato, about how they believe this issue can be rectified. 

Proventa International: Tell me about yourself, and how Inato was founded?

Liz Beatty: I’m CSO at Inato, and have been with the company now for around two years. Before that I was at Bristol Myers Squibb for 16 years in various roles, including clinical operations. When they closed our office in 2018, I decided to go out and see if I could help shape and influence new technology coming into the clinical trial space. 

I joined Inato in the early days of the company, and was well aligned with it on technology’s impact on accelerating drugs to market, helping patients get access to new medicines faster. We’ve since been growing our position as a company that can help all investigators offer the right trials to their patients. 

Inato was founded in 2016 as a feasibility platform for sites and sponsors, running feasibility questionnaires. During this work we heard a lot from smaller sites that they weren’t getting the same opportunities as larger academic centers and didn’t know how to position themselves properly, and heard a lot from sponsors that traditional feasibility models weren’t providing them with the site performance they needed.

Because of this, we believed there was an opportunity to do something different to bring access to smaller sites, while showing reliability to sponsors. In 2020, we halted our feasibility operations and launched our current marketplace model.

Inato’s goal is to make trials accessible to patients, as well as ensure sites and physicians are aware of the trials going on and that they have access to them for their patients. We’re also hoping to ensure trials are inclusive by going to a broader range of sites, as opposed to just the top few that are used most by pharma. 

We think there is an opportunity to be more inclusive in research, and to ensure that underrepresented populations are part of trial datasets. Finally, we want to make all this work more efficiently by accelerating drug development and reducing anything that slows down timelines in clinical trials. 

PI: Why is it so important to engage underrepresented populations in clinical trials?

LB: Historically, clinical trials have been largely performed within Caucasian populations, and even historically taking male participants over female. It’s a very important problem we’re facing as an industry. Even from a broader perspective, in the United States, diversity and inclusion are part of a big discussion around all aspects of our culture and society. 

We need to take this opportunity now to leave no-one out as an industry, and ensure data is representative. It’s the right thing to do from an ethical perspective, but for trial data it’s also important that all patients are represented to treat diseases that affect different populations unequally. 

If our data doesn’t represent populations accurately, then when a drug goes to market, we won’t have reliable data on how effective or safe it is in those patient populations. This is important to ensure treatments are safe and effective for all patients with that disease, not just certain subsets that were in a clinical trial. 

PI: What are the best ways to enroll these communities?

LB: It’s important to realise that participating in a clinical trial is a big decision for a person to make. Trust is an important factor that comes with that. People have trust in their local communities, in the nurses and doctors that they see day to day. The best way to ensure underrepresented populations are better included in trials and medical data is to ensure trials are available near them, with doctors and medical staff that they already have a relationship with. 

This trust in medical providers can really make or break a patient’s decision on whether they want to participate in a clinical trial. Ensuring that local, community sites have access to more trials for the patients can do this.

When Inato started out, many companies were relying heavily on data and data-driven models to support site selection. But there needs to be a combination of data and a current assessment of what the site’s interests, needs and capacities are for a given trial. For this, sites need to be able to raise their hands and self-identify about what opportunities are best for them and their patients. 

PI: Are there any risks specific to partnering with more community-based trial sites? How can these be overcome? 

LB: Pharma companies are certainly very reticent to partner with sites they’ve never worked with before. They don’t know the staff, how the site is organised and run, or how it has performed in the past. This creates a lot of risk, because it’s a brand new working relationship. Even operationally, you need to create new contracts, budgets – it’s all new in such a situation.

At Inato, we try to understand the ins and outs of the sites we work with in the community – their timelines, experience, past performance – all these characteristics that would help position them for an upcoming trial.

We support them all through this process, ensuring they’re overcoming initial challenges which might occur with a new sponsor. Acting as an intermediary between site and sponsor to understand timelines and performance and capabilities helps reduce risk of working with sites on operations. 

In effect, it’s about finding the strengths of individual sites and working to those. This is very important for diversity and inclusion: just because a site is in a diverse community doesn’t mean they actually serve those patients right now. To that end, it’s good to characterise access to patients to a very specific level with sites, in order to understand which patients they’re seeing at their centre, who they’ve enrolled in the past, strategies used to engage with the community, etc. 

It’s a very specific job for every site. You can really help shape capabilities, which patients they serve, and bring them forward to the right trial for them. 

PI: Over the COVID-19 pandemic, there was a shift to decentralisation and a push towards wearable and disruptive technologies, providing more patient data. Will this new data improve representation? Or simply provide more information on current trial populations?

LB: I think it depends on the indication. For some of them, the data you’re collecting could be quite broad and remote. For others, patients would still need to come to the clinic for tests. Additionally, the role of individual doctors treating patients could vary. 

Decentralised trials will overall help sites participate more, as that shift to more flexible systems and greater technological support will definitely generate a shift in clinical trials to improve access in their communities. 

That said, I think the role of the investigator is still very important in many disease areas, and we must ensure broader access to more investigators in the community to allow underrepresented communities to engage better.

PI: Will the investigator role change post-pandemic? 

LB: Investigators still have an important role, and over COVID many have adapted well to performing telemedicine visits and having remote calls with patients. Personally, I hope we don’t revert from the changes that have been made. I think more trials need to be brought to the patient, and the improvement of technology has really helped. COVID-19 has inspired a lot of change in this area. I hope as an industry we continue to leverage technology to bring trials to the patient. 

Often, the reason patients don’t participate is economic, for example not being able to take time off work, problems with childcare, etcetera. What’s happening during COVID should help patients have more flexibility in how they participate, and bring a broader range to trials. 

Joshua Neil, Editor
PharmaFeatures

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