Decentralized format can elevate research: Hawthorne Effect

There are patients out there motivated to contribute to clinical research. According to a recent survey of people who had never been a trial participant​, 92% indicated they’d consider taking part someday.

Still, according to figures from decentralized trial solutions firm Hawthorne Effect, 50% of trials end up with missed visits or patients dropping out completely. This week, the firm received a vote of confidence in its technology’s ability to improve patient recruitment and retention, via a $20m USD Series A funding round led by Northpond Ventures.

Jodi Akin, CEO and founder of Hawthorne Effect, spoke with Outsourcing-Pharma about the barriers to participants, her firm’s approach to improving patient recruitment and retention, and the benefits of expanding access by bringing research to patients at home.

OSP: Please tell us about Hawthorne Effect—who you are, what you do, key capabilities, and what sets you apart from similar firms.​

JA: Hawthorne Effect was developed through decades of experience designing and executing novel and challenging clinical trials around the globe that led to groundbreaking research and delivering breakthrough therapies that changed the practice of medicine- like transcatheter heart valve therapy. The tech and process were informed through years of collaboration with the FDA, investigators, and leading clinical research as the industry sponsor myself.

Our tech team is composed of software developers focused on user experience. Our solution for decentralizing the entire lifecycle of a clinical trial was informed by analyzing the roles of all the stakeholders in the ecosystem. Our aim is to eliminate friction at the site level and for patients by focusing on the visits where data is collected. Through this, we really transform the trial process altogether.

What sets us apart is the novel intersection of our technology stack with the first network of medical professionals curated, certified, and trained specifically for remote clinical trial visits. This is NOT a home health agency plugged in to conduct clinical trial visits.

The Hawthorne Cloud is the organizing backbone for the trial process and takes the journey from recruitment to visit completion to data delivery to sponsors and investigators. But the magic is the patient experiences where and when needed. When we make amazing, trusted, and confident experiences for participants and for Heroes, the rest follows.

OSP: It’s widely known that there are disparities in the demographics of clinical trial participants. Could you please talk about some of the gaps?​

JA: Access is a function of multiple obvious and subtle factors: geo-local (clinical trials don’t happen where patients live), economical (there is an economic burden to patients making their visits), scheduling (clinics provide limited windows and hours for visits, competing with work, life, etc), but more importantly, cultural and trust barriers (HELA, Syphilis project, lack of translating what the potential benefit of participation is, etc.). Hawthorne Effect’s Hero network represents the very diversity of the population and draws from these communities to build trust and meet participants at their level; this changes the paradigm of participation by addressing these barriers not only for ethnic diversity but also gender, age, and other considerations.

Another issue is that clinical trials also fail to reach a diverse group of people because of their design. Clinical trials often eliminate participation (exclusion criteria) if participants live beyond 50 or 100 miles from a clinical site where in-person visits are essential.

Not often broken down this way, but the way I think of a successful trial is that a trial of 1000 participants, requiring 10 visits per participant means 10,000 in-person visits, and more than 100,000 assessments need to be completed to collect the necessary safety and effectiveness endpoints required for FDA approval. This is a heavy burden for both patients and sites; for those living in rural areas without access to transportation, it becomes increasingly difficult to meet these in-person meetings when trial sites are hours away.

The ability to deliver the level of quality required in clinical trial assessments to participants in a rural area, church, homeless shelter, or home will change the equation entirely. This is the very core of the Hawthorne Effect technology and Hero ecosystem — we deliver the trial to participants, on their terms and can still turn over super high quality and timely data to the investigators and sponsors.

OSP: Is there a difference between the “conventional wisdom” regarding reasons for these disparities (i.e. purely reluctance to take part, lack of awareness re opportunities, etc) and reality?​

JA: I believe the reasons for the disparities and equity gaps lie a bit deeper than convenience, location, and awareness factors alone. I believe if participants understood that their participation in clinical trials can not only provide them with access to care in general but that they also may have a tremendous impact on the future of medicine, touching millions if not billions of people.

Think about the participants who signed up for the vaccine trials and how their participation was a huge part of vaccines becoming reality sooner rather than later. I think if we can make the participants' journey not only convenient but also meaningful — we can reduce disparity barriers and accelerate enrollment and timelines of trials. At Hawthorne Effect, we came at the problem of clinical trial continuity through this lens first.

Regarding the conventional issues of logistics, this is still huge and part of the calculus. For example, if I am from a rural, small town in California the closest hospital could be Stanford Medical. My doctor may recommend I sign up for the trial, but that requires numerous, time-consuming visits, not to mention figuring out my travel, the spend, etc. — all these factors play into someone being reluctant to participate in trials.

The reluctance from the community then leads to a lack of awareness about opportunities. This is why Hawthorne Heroes are so important to Hawthorne Effect. Our medically trained staff is equipped to facilitate complex assessments and support the patient experience throughout the study lifecycle whenever, wherever it is most convenient for them. Heroes are geographically distributed in North America, Europe, and Africa, giving us incredible reach to these communities.

OSP: Please tell us about the University of Missouri study​ of cancer patients and trial participation—does this study confirm or conflict with the aforementioned conventional wisdom?​

JA: In some respects, this study confirms conventional wisdom, but it would be important to put these statistics in context to assess whether the incidence rates of the cancer diagnoses correlate to the percent of people of color participating in the trial to understand whether there is true equity there. In other words, there may be a higher prevalence in people of color, hence higher participation.

Regarding the financial factor of higher income, this does reflect the need for financial resources to be able to complete the visits and assessments required for these trials. A while back I analyzed zip code to site distances for patients with various cancers to see what travel distances they needed to participate in a cancer trial. It was stunning to see that typical distances ranged from 150 miles to hundreds of miles — this is a non-starter for a low-income patient who cannot pay for travel nor take time off of work.

OSP: If, as the Mizzou study indicates, people of color are more likely to sign up for trials during treatment, how can it be that trials are still failing to enroll (and retain) such participants?​

JA: This comes back to whether other demographic factors are controlled. Looking at people of color in San Francisco vs. in Greensboro, North Carolina, for example, would likely draw different conclusions. And again, whether the overall demographic distribution of people with the underlying diagnosis is higher in people of color or not.

I think it comes down to whether the patients have affordable, continual access to these trials and most do not. Finally, often in cancer, participation in a trial is the only access to care and this can also explain that statistic.

OSP: Are we seeing improved enrollment and/or retention rates with decentralized trials, compared to traditional onsite studies?​

JA: The unvarnished truth is that for virtual trials and patient-reported trials compliance can be much worse, and for many reasons. Digital platforms alone do not resonate with all demographics and may be challenging where internet or cell access is unreliable.

With Hawthorne Effect, we have the human connection all the way through, even if assessments are conducted through the platform and telepresence. We enable data collection even if internet access is not available. Having a Hero through the journey keeps it sticky for the participant. I liken it to why we do better going to the gym or yoga class than thinking we will do that workout at home (never do).

Another point is that when people talk about decentralized trials, they are talking about the 5% of types of assessments that can be done remotely, not the full picture of physical assessments, biospecimens, imaging, and functional assessments. Still, the majority of trials require these in-person visits.

Hawthorne Effect provides true decentralization by conducting these complex assessments outside of the brick and mortar institutions at homes and in communities, therefore allowing the full trial experience and unprecedented compliance. Our results are astounding; 99% of assessments complete and in window even in very complex clinical trials and even during a pandemic.

OSP: What are some of the reasons you believe DCTs offer patients (particularly from underrepresented groups) advantages when it comes to continued participation?​

JA: The main reason DCTs offer patients advantages is the improved access. Decentralized clinical trials enable researchers to mitigate a lot of the access barriers by conducting trial assessments anywhere, whether it be virtual or at a home, church, shelter, or clinic, compared to site-reliant trials that require patients to continually travel to that site. We’ve found that patients are more willing to engage in a trial long-term if they’re able to do so on their own time/turf.

As a clinical trial architect myself, I think the real potential disruption of truly decentralized clinical trials is the idea that having ubiquitous access to patients anywhere, anytime will allow us to develop more novel trial designs that were not possible before technology and distributed models were here. I am most excited about that! I will be bold enough to throw out the idea that traditional clinical trials will be a thing of the past when decentralized models are fully realized.

OSP: How does your DCT platform work, and what advantages does it offer from similar technologies currently being used.​

JA: Ideally, we work with the sponsor from the top of the trial design to the full execution by creating the study visit portals that connect the patient journey to the data collection while complying with regulatory standards and practices. We also can come in late into a trial and “rescue” longitudinal follow-up in the same way. Our start-up times are fast and efficient because the platform is intuitive and integrated from end to end.

Most decentralized platforms integrate preexisting features such as eCOA, eConsent, EDC, ePRO. Hawthorne platform does all of that, but this is the only platform that does so by integrating the visit first and integrating a professional network.

Hawthorne Cloud is a 21CFR, GDPR-compliant platform that has been used to complete more than 25,000 assessments in more than 15,000 in-person or virtual visits for over 50 clinical trials across a wide variety of therapeutic areas and phases. Its novel architecture manages all aspects of the clinical trial journey for patients and investigators from recruitment through study exit, including clinical assessment development; visit choreography; data acquisition via patient-reported outcomes; devices; interoperability with health system databases and directly from all forms of clinical visit modalities (in-person, via telepresence and in remote geographies).

HawthorneHeroes is a robust specialty network of multi-disciplinary medical professionals is made up of more than 2,200 highly-vetted and highly-trained HawthorneHeroes. Heroes are geographically distributed in North America, Europe, and Africa to deliver compassionate care to patients; they are equipped to facilitate complex assessments and support the patient experience throughout the study lifecycle.

Capabilities include complex clinical and physical treatments and assessments such as medical histories; consenting; ultrasound imaging; neurological; cognitive and functional assessments; complex blood draw and sample management; adverse event reporting and more. These medical professionals shape the future of medicine by playing a role in clinical trial research that enables them to have an impact on individual patients while improving health care for humanity.

OSP: Please tell us about your firm’s involvement in Operation Warp Speed, including what you contributed to the effort, and lessons your company learned from participating.​

JA: Hawthorne Effect has strong collaborations with academic institutions leading groundbreaking clinical research. Through such relationships, investigators of a couple of the OWS trials introduced Hawthorne Effect to the NIH as a partner to ensure that post-discharge follow-up visits are completed in time-sensitive windows and that biospecimen and blood samples are collected and processed according to protocols.

We are also responsible for the general enabling of clinical sites to extend their capabilities. It has been a great partnership and we are increasing the number of sites we are supporting throughout the country. We have conducted hundreds of visits in geographies that would be typically precluded in trials or have compromised follow-up. Some of our favorite stories include following a patient discharged to a homeless shelter, conducting visits in rural communities, and enabling participants representing diverse and vulnerable populations. Most importantly, enabling high-quality, long-term data follow-up is essential to answering questions about the long-term impact of COVID and COVID treatments.