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To drive trial diversity, one company is bringing them to the patient

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Imagine this: You’re newly retired and are ready to become a “snowbird,” spending your winters in sunny Florida and your summers in the northern U.S. Then, you receive a diagnosis for a disease with a treatment that is enrolling patients in clinical trials near you. However, to participate, you would have to trade in your flip flops for snow boots indefinitely.

It’s a problem that’s more common than you might think, David MacMurchy, CEO of the clinical research solutions provider Lightship, said. Geographic barriers like this can often deter people from enrolling in clinical trials — and it’s one reason many in the industry have turned to decentralized study models, which allow for enrollment of a more diverse patient pool who might not otherwise be able to participate.

It’s also one of the key barriers to trial access, FDA Commissioner Robert Califf said during the Milken Institute’s Future of Health Summit in early December, noting that it particularly limits participation for people in rural areas.

“If you live in a rural place three hours from the nearest endocrinologist and you have hard-to-treat diabetes, that’s a big problem,” he said.

Many in the industry are attempting to close this gap by making it easier for patients to access trials in their day-to-day lives. Earlier this year, CVS Health inked a partnership with the decentralized clinical trials software company Medable to help patients enroll and participate in trials right at the pharmacy counter, and Walgreens launched a similar clinical trials business with partner Pluto Health in June.

Lightship is taking a slightly different approach by meeting patients where they are — literally. Self-described as a “virtual-first” clinical research provider, Lightship aims to design accessible trials using hybrid designs that cater to patient needs. In some instances, it even uses tour-bus-sized “mobile research units” to bring the clinical site directly to patients who might otherwise not be able to participate in a trial that could not be conducted virtually.


“We’ve really focused on how we create the continuity of care through the clinical trial to build that comfort with the patient populations.”

David MacMurchy

CEO, Lightship


In pursuit of its goal, Lightship announced a partnership with the digital health company Acclinate earlier this year to improve engagement among communities of color in a neurology clinical trial — a move it hopes could lead to longer lasting relationships with the groups it serves. The collaboration leverages Acclinate’s #NowIncluded diverse digital community and Lightship’s trial design approach to enroll and retain patients in the trial.  

Here, Scott and MacMurchy discuss the company’s approach to eliminating barriers in trial enrollment, how it’s building trust within communities and why developing long-term, care-based relationships with trial participants is important.

This interview was edited for brevity and style.

PHARMAVOICE: Tell me about Lightship’s virtual-first approach.

David MacMurchy: We think about three main areas that are important. So, access — and access is defined as you can live anywhere and be in a clinical trial. Historically, and largely today, if you don’t live near a site or a clinic, it’s really hard for you to get onto a trial and that plays out in a number of different ways.

The second thing is virtual first supports choice, which is (about) where you can receive your trial treatment. Within the restrictions of the (trial) protocol, can you receive the treatment in a clinic, can you receive it at home, or can you receive it in a third place — a mobile unit, a local community center, or a room in your place of work if that’s convenient?

If you create access for all patients, regardless of where they live and you create choice around when and where they can receive your trial, our thesis is you start to drive a real increase in diversity and deal with the equity challenge that exists in clinical trials. Today, that equity challenge is summed up as basically the lowest socioeconomic people do not have access to clinical trials and the disproportionate number of people of color in the lowest socioeconomic profile means that if you’re poor, and you’re a person of color, it’s much harder for you get access to clinical trials. That’s what we’re trying to solve.

How does the mobile research unit fit into that?

Rachael Scott headshot

Rachael Scott, COO, Lightship

Permission granted by Rachael Scott

 

Rachael Scott: Many people actually don’t want someone coming into their home but then, equally, the (clinical or academic) site is geographically too far from them. This is about being able to create an extension of that site and take it into a community where people can go to somewhere that is a high-grade, clinical-fitted unit and feel that they’re part of something, feel that they’re respected by just the way in which the unit was set up. But it’s not in their home, so it’s closer in proximity but it’s not overstepping the mark.

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