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Connecting ALS is a weekly podcast produced by The ALS Association in partnership with CitizenRacecar. We aim to discuss research and technology developments, highlight advocacy efforts, and share the personal stories woven through the community.
This transcript was exported on Feb 08, 2023 - view latest version here.
Dr. Paul Larkin:
And I think that's the other point to make here is that more, better, faster is a good shorthand. But really this is part of a much broader funding strategy where we're funding across the entire ALS research ecosystem with the goal of getting new and better treatments.
Jeremy Holden:
Hello everyone and welcome to Connecting ALS. I am your host Jeremy Holden. Clinical trials are the most reliable and ultimately the fastest way to translate promising laboratory science into new and better ways to treat and care for people living with als. However, many people with ALS are currently unaware of clinical trial opportunities, have misperceptions about research or are unable to access trials because of distance, finances or other obstacles. In order to create more opportunities for more people from more communities to participate in clinical trials, the ALS Association in 2022 launched the Clinical Trial Capacity Awards program. The association recently awarded 4.9 million to 13, established an emerging ALS clinical trial sites in order to help speed the testing of ALS therapies through clinical trials. To learn more about the inaugural class of Clinical Trial Capacity Awards recipients, I turned to Dr. Paul Larkin, director of research at the ALS Association. Well, Dr. Larkin, thank you as always for being with us here on Connecting ALS.
Dr. Paul Larkin:
Happy to be here, Jeremy.
Jeremy Holden:
Yeah, we're here talking about the association's, the first cohort of the Clinical Trial Capacity Awards program. And let's just start at the beginning. Why did the association launch this initiative in 2022?
Dr. Paul Larkin:
Yeah, I think the short answer is that it fits with a principle we often pursue around here, which is more, better, faster. We want more opportunities for people with ALS to participate in clinical research. We want more clinical trials because we think that will lead to more therapies. We want better trials, both for participants, because it certainly can be burdensome to participate in a clinical trial. So a better trial would be one that reduces that burden. We want better trials for the clinicians and medical research staff who are often overstretched as they devote so much time and effort to these trials. And we want better trials for the biotech and pharma companies who invest so much money in these trials. And we want all this to happen faster because with als, we can't be satisfied with the status quo, because despite what I think are some really promising advances in the field recently, we do need everything ... We need to do everything we can to move this whole drug development process along faster.
I think we can do that with this and with a number of other efforts that we're working on. And I think that's the other point to make here is that more, better, faster is a good shorthand, but really this is part of a much broader funding strategy where we're funding across the entire ALS research ecosystem with the goal of getting to a better treatments. So we start by funding fellowships, whether for clinicians or for researchers. We fund basic biology that generates new ideas for therapeutics, and we fund preclinical research, which gets these ideas ready for clinical trials. And all these things are really pushing programs towards the clinic. But if [inaudible 00:03:18] programs are successful and we do see more potential programs, more potential ideas ready for trials, than clinical trial capacity could become a bottleneck.
And if there aren't enough trial sites or if there aren't enough people with ALS who have access to trials, then it might not matter as much how many good ideas are ready for testing if we can't test them as quickly as we'd like. And we're already seeing some evidence that that's the case, that recruiting for clinical trials is slower than it used to be. So with that in mind, just as our preclinical research funding is pushing ideas towards the clinic, we started thinking about boosting clinical trial capacity as a way to pull those ideas into clinical trials as quickly and efficiently as possible, so that ultimately we can get answers and hopefully therapies more quickly.
Jeremy Holden:
The association recently announced the first projects that would be funded through the Trial Capacity Awards program. The first cohort has been announced. I want to get to that in a minute, but as you started to dig into recruiting potential recipients and going through the applications, what were some of your expectations? What were you finding along the way of understanding who was stepping forward to try and be part of this?
Dr. Paul Larkin:
Yeah, it's a great question because it was an educational experience for us because this type of effort hasn't really been done, certainly in ALS, and I think it's relatively rare across other disease areas also. So we weren't sure what would be the right way to fund this. And so we talked to a lot of leaders of clinical sites and staff at clinical sites about what barriers they face, and we came up with the general idea that these should be relatively large awards. We went with 400,000 over four years, and the four years is important, which is longer than most of our grants, because we want whatever solutions these trial sites are putting together to be things that can become sustainable over time. And so we wanted to give them time to establish new programs that would really be able to continue after our funding has gone.
And so we're tracking what happens with those programs. We're hoping to get some new best practices out of that and spread them to other sites. But really, with the specific types of programs that we fund, we wanted to keep it really open because we got a lot of different ideas from our conversations with different leaders in the field. And it seemed that different types of clinical trial sites would also have different ideas. And so we were interested in funding new solutions, both at established clinical trial sites that have been running trials for years and have a large practice established and at emerging sites where there may be few or no opportunities for clinical research currently, but there is a willingness to go down that road and provide opportunities for that population in, perhaps, an underserved area. And so those different types of sites are going to have different needs, and we really just wanted to leave the funding opportunity open to as many creative solutions as we could see coming in.
Jeremy Holden:
Yeah, this is an important conversation. I think it touches on something that I've heard and we've heard here on Connecting ALS from people in the community about the frustration of trying to find a clinical trial that they can participate in, trying to get in. So really kind of important work that we're talking about here. I mentioned the first cohort, 4.9 million dollars awarded to 13 projects, and looking at them, it seems like there's a natural breakdown, maybe two general buckets of research that we're looking at here. As you look at the field of 13 research projects, what strikes you about how these are kind of organized?
Dr. Paul Larkin:
Yeah, I think you're right about there being two large buckets. And I'd say the first is really around accessibility of trials, and the other is really around improvements to the sites themselves. So to go into that a little bit more, accessibility could be simply geographic accessibility. That was one thing that came up pretty often is that people would want to participate in a trial, but it was too far away. The logistics were really difficult and expensive, and there are a variety of costs with traveling that far. And to be fair, many trial sponsors do pay for some of those costs, but we feel that more support in that area would make sense. And so that's one thing that we wound up funding some of. But even beyond travel, another way to avoid some of that is to simply open a site that is closer to more people who want to participate in a trial.
And so we did fund a couple efforts to open new sites or open sort of satellite trial sites where there is an established trial site that works with a smaller regional provider to expand the offerings they're able to provide there as well. But accessibility beyond something like logistics could be more like knowledge of trials. So that could mean that we are funding outreach to underserved populations. It could mean that we're funding translation efforts, so translating clinical trial educational materials into languages other than English, and it could mean an amalgam of those approaches where we have a clinical trial navigator or somebody like that who is on staff at the clinical site who's just there to help with all of these questions that trial participants may have about how to do this, how best to do this, which trial is right for me. So a lot of those issues around making trials available to people that want to participate is something that we saw a lot of.
And then the other bucket was really around improving the site itself. And that could be something as simple as buying the freezer that's necessary to store the biospecimens that are part of the clinical trial. And that sort of thing is something that the biotech and pharma companies that sponsor clinical trials will check for. They'll ask if you have the right equipment on a site that can say yes is one that can then offer more clinical trials. Or alternatively, we saw quite a few applications and funded quite a few applications that were around hiring and training more staff, because this is often an activity that is a bit outside of the day-to-day job of the clinicians that are running these sites. And so it's an additional burden on that staff.
And so the more protected time that they have to run clinical trials, and the more staff that are trained in the techniques that are necessary to run a clinical trial, the better, and the more they're able to offer a wider variety of trials. But I think those are the two big ones, is sort of making trials more accessible in general, [inaudible 00:09:43] people who would like to be in them, and then improving a site's ability to offer more and better trials.
Jeremy Holden:
No time here to go through all 13 projects that were funded. And we will share links in the show notes so people at home can kind of explore some of the projects that are going to be kind of facilitated by this grant program. But what are some of the projects? Are there a few that you think that strike you as being illustrative of the work that needs to be done and will be done going forward to expand access to clinical trials?
Dr. Paul Larkin:
Yeah, sure. I mean, I think all of these efforts are really exciting in their own right, and many of the sites are pursuing a variety of different efforts, but there are a few that stand out and just sort of easy to understand, easy to summarize type of way that conveys the excitement that we have about this program. And so there, I'd start maybe with Dr. [inaudible 00:10:33] at the University of Puerto Rico who is working to create the first center for ALS clinical trials in Puerto Rico. And so that's awesome because that's obviously a population that needed to travel quite a ways to participate in trials. And so that was a limiting factor for many people living there. And similarly, we're funding Jackie White Soul at the St. Faas Regional Medical Center Research Institute. And that is the only clinical trial site in Idaho and one of the few in that region of the country.
And so this idea of funding new sites or funding expansion of operations at sites that serve populations that don't have much access to clinical trials is one that we saw. Get it again. And it's certainly illustrated by it by both of those proposals. But access, as I mentioned, doesn't have to be just geographic. And so for example, we funded Dr. Terry Hyman Patterson at Temple University in Philadelphia to focus on recruiting more patients from underrepresented populations. And so those are people that may just be down the block from the clinical trial site, but don't have much awareness of clinical trials or trust in the process because of just lack of educational materials that are available to them or lack of outreach to that community in particular. And so they're working on a couple of efforts to reduce the burden of participation for the people who may be right there but not aware of or so far interested in participating in clinical research and really give them access to the world class center in their backyard,
Jeremy Holden:
Exciting projects there. And really throughout. And again, we'll share some links in the show notes so folks can explore each of those projects. Dr. Larkin, before we let you go, any closing thoughts about the clinical trial capacity awards program or the research program in general?
Dr. Paul Larkin:
Yeah, I think this is a really exciting project that is part of their strategy of really funding the whole of the ALS research ecosystem. And it's a new one for us, like I said, a relatively rare type of grant program. So I think it's a great learning opportunity for us to see what types of applications come in and also to over time see what funded programs produce and if there are new best practices that we can glean from the successes of these projects and help to move them to other sites across the country. So that's the hope is that we're not just funding these 13 clinical trial sites, but we're gathering knowledge that can help the whole network of clinical trials across the country and improve the accessibility and efficiency of clinical trials for everyone that we serve.
Jeremy Holden:
Dr. Larkin, thanks again for your time this week.
Dr. Paul Larkin:
Thanks, Jeremy.
Jeremy Holden:
I want to thank my guest this week, Dr. Paul Larkin. To learn more about the ALS Association's Clinical Trial Capacity Award recipients and the inaugural class, check out the links in the show notes. If you like this episode, share it with a friend. And while you're at it, please rate and review Connecting ALS wherever you listen to podcasts. It's a great way for us to connect with more listeners. Our production partner for this series is Citizen Race Car. Post-production by Alex Brower, production management by Gabriela Monte Keen, supervised by David Hoffman. That's going to do it for this week. Thanks for tuning in. We'll connect with you again soon.
ConnectingALS_020923_Ready1 (Completed 02/08/23)
Transcript by Rev.com
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