Parexel is bringing clinical trial recruitment where the patients are — pharmacies and neighborhood care facilities.
In the latest industry initiative to enhance trial diversity, the clinical research organization is partnering with CVS and Javara to make it easier for patients to access and join research studies in community health settings, such as MinuteClinics and hospitals.
“We wanted to capture the 95% [of people] that don’t get access to research,” Clare Grace, Parexel’s chief patient officer, says of the program, announced in June.
Called the Community Alliance Network, the initiative aims to serve as an “add-on, not a replacement” to other, more traditional trials the company manages, Grace says.
“The research infrastructure we have built over many decades is still going to be needed,” she says, especially for trials of more complex treatments and in certain indication areas. Rather, this initiative aims to recruit a more broad, representative population of patients for standalone trials.
"We know that to get true representation in trials we need to include other sources for patients. We really wanted to seek out those organizations that would be able to tap into different locations, different demographics, as well."
Chief patient officer, Parexel
It’s no secret that the pharma and biotech industries have struggled for years to improve patient recruitment and diversity in trials. Less than 5% of people in the U.S. participate in trials, according to 2021 data from the NIH and out of the patients that do participate, only 2-16% are from racial and ethnic minority groups.
Parexel’s initiative is the latest in a series of moves by CROs and retailers to bring more patients into the fold by allowing them to enroll in studies at their local pharmacy counter. The announcement of the new initiative comes just months after CVS inked a similar deal with decentralized clinical trials organization Medable, which is also partnered with Parexel, to provide access to research studies at select MinuteClinics. Walgreens also recently launched its own clinical trials business with Pluto Health and is looking for ways to expand trial offerings for patients.
Grace says this competition is a positive.
“Honestly there is more than enough to go around, and the most important thing is that patients get access … and more pharmacies support research awareness,” she says.
Here, Grace shares how Parexel’s initiative differs from the other community-based recruitment programs and how the company plans to leverage its partners’ data to reduce drug costs.
This interview has been edited for length and clarity.
PharmaVoice: How long has the Community Alliance Network initiative been in the works?
Clare Grace: It has been in the works for quite a while, actually. We have been working on this I would say for probably about nine months to almost a year.
Why are CVS and Javara your first two inaugural members?
We already have an amazing alliance site program which targets those big research institutions. The patients that go to those are of a certain demographic — usually the quite privileged, city-center dwelling sort of population who have access to those academic medical centers that are at the top of their game. But the data shows that’s only 5% of the population.
We know that to get true representation in trials we need to include other sources for patients. We really wanted to seek out those organizations that would be able to tap into different locations, different demographics, as well. So CVS obviously is a big, national organization that has a great deal of respect in the community and a great deal of trust. And it’s located on almost every corner, isn’t it? We were keen to bring CVS on board and they were very excited.
For Javara, [an integrated research organization], it was very similar in that they work with multiple large healthcare systems. They are going in and taking what they’ve learned from a very professional research environment in the IMO world and bringing it into those much smaller hospitals. So they have access to a vast number of patients that would not be accessible through the normal research angles.
They’re both looking to be in this space, they’re both able to tap into those areas of unmet research potential. They’re good because they’re both national organizations. We don’t expect this to have a large number of partners. This is very much going to be a few select large organizations that can help us move the needle.
How is this initiative different from what Walgreens is doing?
I’m not convinced it’s massively different. However, I think the difference that we bring as a CRO is that expertise of running clinical trials for 25 years. We’re able to bring that to these types of organizations that have never done it before, so we understand which protocols are most applicable, which ones really will resonate in these communities and in these settings. Then, in addition to that, we have longstanding relationships with so many pharma and biotech clients that we’re able to bridge that gap.
Do you see this as the two entities, Walgreens and CVS, going head-to-head for patients?
Competition is not necessarily a bad thing. I would love to see a world where any patient could walk into any pharmacy and get access to clinical trials.
What is the vision for the types of services that are going to be provided?
It’s not gene therapy yet. It probably will never be gene therapy at CVS. But for Javara they have the potential to possibly build into that. There’s two elements to this. CVS and Javara are aligned in the way that we’re working with them, but they are different. They are different settings, and they have different needs.
When we look at which are the best environments for both partners they do differ. For CVS it is very much about some of those low intensity, high volume studies: chronic disease, diabetes, hypertension, obesity, vaccines. In addition to those, we’re looking at CVS for their decentralized capabilities and how we can supplement potentially more complex studies in the inpatient setting.
For Javara it’s a little different because they’re integrated into a healthcare system. For them, it’s very fluid. Really what we’re looking to do with Javara is work with them to build more investigators, to build more capacity in those settings. That then opens the door to so many different indications and opportunities.
Is the data that comes from this going to feed into the Parexel machine?
Absolutely, it is. It really helps us understand where these populations are and where we should be going. Also, it enables us to do some clever things on the back end. What we do now as an industry is ask sites to enter data into an electronic data capture system and then that data is processed. Now, there’s an option for us to look at whether we can pull this data out of the back end and not require that data entry piece. That leads to cost reductions in the price of research and drugs.
You noted that you want to reach 95% of patients who don’t currently participate in research. How long do you think it’s going to take?
We’re trying to target the 95%. I don’t think we’re going to get 100% of people participating in research, let’s be honest. Our goal, really, is I think these organizations have the potential to really provide between 20 to 25% of Parexel’s patient demand over the next five years. That’s what we’re aiming for.
Is there going to be training on the ground floor for individuals who work at these MinuteClinics?
Absolutely. To build those MinuteClinics into clinical research endeavors it does take time, effort, investment. CVS is putting all of those pieces in place. They are an extensive organization with great options to do that. The one thing CROs are experts in is scale-up. We have big, global scale and we’re used to juggling large numbers of staffing across multiple clients. There is a lot that goes into it, and that’s why it’s taken nine to 12 months to get to this point.