On March 9, HC3 collaborated with Ziegler to host a discussion exploring the benefits of decentralized clinical trials. In this conversation, experts provided insight into how they are developing technologies and implementing solutions-based approaches to support clinical trials being hosted outside of their normal structures thanks to technology advancements.
Meghan Phillipp, Executive Director, HC3
Grant Chamberlain, Managing Director, Healthcare Corporate Finance, Ziegler
Patrick Walsh, Managing Director, Healthcare Corporate Finance, Ziegler
Jennifer Junis, Senior Vice President, OnCall Digital Health, OSF Health Healthcare
Melissa Nezos, Vice President, Clinical Operations, Firma Clinical Research
John Reites, Chief Executive Officer, THREAD
Watch the Recap | Link to YouTube
Grant: Please define decentralized clinical trials. John: There is a regulatory definition from the FDA, in addition to other definitions. Essentially it is about taking research that has always happened in one central clinic, and changing where, how, and when data gets collected. Research can happen in both clinical and non-clinical settings through telehealth, home health (going into the patient’s home), and so on. Through access and the usage of technology, new types of data models and data captures are available. We are moving research not only from clinical settings, but a lot of other locations as well.
Melissa: Staff (e.g., a nurse) can now go into a patient’s home and allow them to participate in a trial when previously we could not do that.
Patrick: We will now begin defining the stakeholders’ needs and values that we have around the table, by getting a sense for how each of your organizations fits into the larger story of decentralized clinical trials and why decentralized clinical trials are compelling to your segment of the market. (To John) What benefits are there to decentralized clinical trials for pharma sponsors in particular?
John: We have developed decentralize trials to respond to consumer demand and because the global economy has transitioned to a place where we all do things in omnichannel. Decentralized clinical trials (DCTs) is a tremendously beneficial model because it allows flexibility for participants.
It is important that sites have the tools they need to support DCTs. THREAD and similar organizations support providers like OSF in rolling out DCTs by providing technical assistance, frameworks, digital tools, and so on. DCTs open up geographies and make study designs more inclusive (e.g., getting to rural populations). It is also an opportunity to cut back on the financial burden of producing the trial and reinvest those dollars into the system in other ways.
Patrick: From a provider standpoint, what benefits do providers gain from adding decentralized capabilities / offerings to their trial sites?
Jennifer: The hub-and-spoke structure is what helps systems like OSF address inequities, social determinants of health, and other barriers or factors that prevent participants from being viable candidates to participate. Being able to scale up these solutions by centralizing the parts that need to be and decentralize everything else to provide better access and build out relationships is critical.
Most of their hospitals are in rural settings, and they struggle with access. Decentralized the way they are configured; they are creating pathways for access to these communities that have limitations like transportation to meet the patients where they are. Their digital health vision is really to meet them where they are on their journey.
Patrick: Can you please speak also to the patient or participant experience. Do patients recognize its better now than it used to be? Are they aware of how it is going to be different from now on?
A lot of OSF hospitals are in rural areas and the pandemic also pressed on levers where they were not willing to leave their homes due to COVID-19. This past year has unveiled the “belief bias” that OSF had previously towards some of the populations they served being flexible or able to adapt. However, this has been a critical opportunity for their patients to participate in new ways especially because of the pandemic and they are able to eliminate barriers such as transportation to engage them where they are on the spectrum.
Patrick: What has helped DCTs to progress as they have? How are DCTs used today and how will they be used in the future?
Melissa: With COVID-19, we have been running clinical trials where people want to be included at their home. DCTs used to be very niche, but now companies want to be patient-centrically focused and offer more flexibility with these models. There is not yet one area where DCTs have shown to work best, but currently they can be done with oncology and dermatology, albeit very different experiences. Rare disease immunosuppressed and motility issues have been particular areas of focus for DCTs. And increasing diversity and access is very important.
Patrick: What are some key changes that have taken place that have made it possible to use DCTs effectively?
John: Our overall level of comfort with technology has shifted and become standard operation. People are accustomed to technology. DCTs are actually much more intuitive for participants and they expect the DCT model over what it may have traditionally looked like in the past. The pandemic caused everyone to upgrade their technical equipment, and the infrastructure of the economy moves the needle on these kinds of things as well. We used to do trainings for telehealth visits, but now it is more common and organic to have video and phone visits with your provider than it used to be. Stakeholders have to take advantage of this moment and lean into the situation or they will regress.
Patrick: What are operational changes that have happened with DCTs? Where do DCTs not rely on tech?
Melissa: Regulatory challenges are difficult operationally. Regulations vary across the globe and are not always clear or kept updated. You can run the same DCT globally, but will have different rules in the U.S. vs. France for example – this is a challenge that it has not harmonized yet. While we cannot necessarily decentralize every protocol, we can start with that lens from the beginning. Creating an implantation plan from the onset does not even require any tech. More and more people have the tech, but the challenge is for stakeholders to unlearn some of their behaviors.
Patrick: How does OSF/providers think about the embrace of DCTs going forward?
Jennifer: It is too soon to tell. Thus far, OSF has been reactionary to the pandemic and is just now taking a step back to look forward with strategy in mind. We are always asking if we should build it or buy it and how to get the best value to the patient. This analysis is still being done, and DCTs are certainly a differentiator and a big part of the future for OSF. Keeping costs down is key so that reinvestment in DCTs can and will continue.
Patrick: What does the future of DCTs look like?
John: DCTs have been around for a while, but the general popularity has grown a lot recently and will continue to grow. DCTs will move the needle for all of research and will eventually become the standard. It’s possible we will change the name from DCTs to just trials or something like that.
Melissa: COVID-10 has made clinical trials more mainstream because of the vaccine trials. It may offer some demystification of clinical trials in general. “The DCT book was written long ago, but just got signed to a big movie deal.” The industry needs to be brave enough to continue down this path by developing and implementing more DCTs.
Patrick: How has telehealth changed because of DCTs?
Grant: Telehealth is about expanding access. So, if things can be done at home, that should be a viable option because many folks in cities and more rural areas struggle to receive care or get involved with DCTs.
Patrick: With DCT's getting access to patients in more rural areas and outside of city centers like you mentioned, how are the sites or supporting organizations getting to those patients or who is doing the patient visits?
Melissa: Firma works with sponsors or CROs to find people who live within an hour driving distance from their home. They will source a nurse or a phlebotomist, depending on what is needed to be administered. There are a lot of regulatory barriers and compliance and a lot of close coordination accordingly (e.g., there might be ten homes visits and two in-clinic visits).
Patrick: What are your perspectives on the global/macro-level of clinical trials?
John: THREAD is currently running DCTs in over 50 countries. The context of the use of a DCT is really important country to country. There are global differences in regulations as discussed. The device-provisioning is often done in eastern Asia, even though devices are widely spread throughout the population. Overall, the flexibility the DCT model is working well despite any cultural norms or differences.
Patrick: What are some of the site-specific costs associated?
Jennifer: OSF is still fairly new to this space so we have some startup costs and are still feeling things out. Trial and error with IT, overall data outcomes, and scale of the trial all impact cost.