Jodi Akin, Hawthorne Effect - Making Clinical Trials Accessible | LSI Europe '22

Transcription

Jodi Akin  0:06  

So the pandemic changed all of our lives. And believe it or not, it actually claimed changed clinical trials for the better. And the reason is that, you know, when shut down and shelter in place and stayed home orders happened was actually terrifying for the world of clinical trials because they just stopped. New trials couldn't start only elective emergency procedures and hospitals, and patients couldn't get back to the institutions for their clinical trial follow up. So many drugs and devices, their clinical trials globally were halted. But the problem existed way before the pandemic. The problem was that clinical trials don't happen where patients live anyway. So the burden of going into hospitals and navigating their clinical trial journey has always been problematic. And the limitations are that we expect clinical trials to happen at the clinical site. That's where the patient visits happen. The procedures happen clinical oversight labs, and the whole infrastructure for patients to participate in trials are happening at a brick and mortar institution. But that's where the barriers are, is again, trials don't happen where patients live. So the catchment areas of these institutions aren't really in the pockets where patients live. And that explains why we lacked generalizability of data and the inclusiveness in clinical trials. So we limit the patient pools that actually have access to these catchment areas, we lacked diverse and Representative populations, the visit burden is just too high, no matter how wonderful, beautiful and academic institution is, it's just really hard for patients to navigate to get there. And the sites themselves, they're overburdened as well competing between clinical trial needs, and regular clinic needs. So Hawthorne Effect is changing this landscape forever. We started before the pandemic. But the pandemic really illuminated these issues that have been around for decades. So what we do is we mobilize access to patients to participate in clinical trials from anywhere and anytime, regardless of how complex the trial is, then essentially we mobilized all the patient journey outside the institution. We do that with a combination of technology, and a network of people. So I'll explain that. We have transformational technology that includes all of them sort of underpinnings of a clinical trial management system, including electronic data capture and all the things that we need to manage clinical trial workflows. But it also manages the workforce to go to see patients. And that's the magic is what we call Hawthorne heroes, an international or global network of medical professionals who can bring the clinical trials to the patients. And so therefore, we are now able to extend the reach of brick and mortar institutions and our academics so we don't intermediate them, we actually extend their reach and their catchment areas, and really bring the hospital to the patient. So this is our global network of Hawthorne heroes. And this is really special. It's not a home health service or home health model that's kind of patched into clinical research. These are highly curated medical professionals that are of a very wide variety of medical specialties, physicians, advanced practitioners, technologists, like imaging specialist and phlebotomist. And they're curated and they're actually like a gig economy or gig network. So it's sort of like clinical trials meets an Uber concept. We specialize in complex trials, really grounded in very complex things that wouldn't otherwise need to happen in the hospitals. There's more than 3000 heroes in our network across the 50. United States and outside United States as well. So clinical trials are complicated, especially in this world of med medical technology, where we require multi modality of data to render whether new technologies are safe and effective, and are scalable. So we need to measure things like physical assessments, functional assessments, biometrics and imaging, and Hawthorne effect has mastered the way to bring what would be of the excellence of your most primary institutions at the same quality and conformity in the home. So this is sort of ground zero for me for Hawthorne effect. I've led global clinical trials for more than 30 years, bringing amazing breakthrough technologies to the market, like transcatheter, heart valve therapies and other breakthrough therapies that required not only FDA approval or global regulatory approvals, but really evidence To drive adoption of a new procedure, and the way I broke it down is that it's all about the data. So if you take a trial of 1000 subjects who need 10 visits over time, where there's 10, or 15 assessments per visit, you're talking about 100,000 assessments that need to happen to deliver those millions of data points required for your regulatory approvals and market adoption. And this is ground zero what we started with in terms of building out hall floor. So we started in 2016. Commercially, the company started 2015. And these are all the different areas that we serve from drugs, devices, a digital health and population health, and in all of these therapy areas, demonstrating that the concept is ubiquitous and conserve different therapies and different types of sponsors. And through this, we have more than 200 clinical sites on our platform that are using us and adopting. I'm gonna give a couple quick examples in terms of our success. So this is a study, that's actually an academic study founded by the leaders in cardiology and cardiac surgery globally, called a preview valve study, I'm going to demonstrate where Hawthorne effect is actually conducting the trial end to end without a brick and mortar institution. So going back for a second, the population is coming direct to consumer. So CVS health is our source of patients. Columbia University is the core lab and data managing center. Vanderbilt is the bio banking center. And the pilot study was funded by Edwards life sciences. And the idea is, if we can cast the net to 5000 Random patients, can we establish with the prevalence of heart valve diseases, this kind of trial would be 100 times more expensive and years down the road, almost impossible to conduct in any other way. So what we're doing is, CVS has a flyer that's gone to their patients in targeted zip codes and geographies. And the person can either click the the link to the website or QR code, they come to a Hawthorne effect landing page describing the study in multi languages, a subject will apply to the study and they come onto the Hawthorne platform. From there, we do the screening and the E consenting, the enrolling, and then scheduling of visits and going out to the homes. So what's happened is we launched this pilot in April 20 and enrolled the 500 patient study in less than four months, which for any of you have ever done a cardiovascular clinical trial, this nature is literally neck breaking speed. And then the visits themselves, we are way ahead of plan and those visits should be completed in the next week or two. These are where the patients are. So this is astounding. Because normally, you would have to put up a 50 or 100 sites to be close to those patients so that they can go into the hospitals for their assessments. And we've seen patients from Hawaii all the way to the northern corner of United States. Another example is a pivotal trial. This is Abbott. So this was the first trial then embedded Hawthorne effect into their pivotal study. And we met the enrollment goal early. The utilization is extremely high. But most importantly, the quality of the data is really high and consistent across the board. You could see by these maps, the catchment areas are really wide for these very famous institutions. So no longer do they have to draw a you know, a small circle around their institutions. These red dots are patients participating in the trials for these major institutions. And you could see it strong representation across the United States. So the market is growing. It's called decentralized clinical trials, anticipated to grow exponentially over the next few years. But this is just a small dot in my opinion of what our capabilities are today, with the bottom square being the current clinical trial market. But you can imagine what we could do now to democratize clinical research, and do broader and broader studies. But most importantly, on the patient is now at the center of clinical research. Our patients love it. They feel really connected to their institutions, but in the comfort of their homes. One patient said I'll live longer just to have my heroes come every year, which is the definition of the Hawthorne effect. So the future as we learn of humanity depends on well conducted clinical trials, and we're really excited to bring this new capability to the world