In November 2022, the Decentralized Trials & Research Alliance (DTRA) held its annual meeting in Boston. At the time of the meeting, the Life Science industry was 2.5 years into the COVID pandemic and the push for hybrid and decentralized clinical trials (DCTs). The meeting was a chance for members of the Alliance to come together to discuss the progress that has been made and what the future holds for the emerging technology. I took this opportunity to speak with Craig Lipset, co-chair of DTRA, about the meeting and the topics discussed.
Ed Miseta: What were the main topics you heard discussed at the DTRA Annual Meeting?
Craig Lipset: The main themes at the Annual Meeting were stabilizing the core of decentralized trials — our ability to define and scale the core attributes of decentralized research methods that sponsors, sites and regulators are rallying around. While we are doing these things, we cannot lose sight of the need to continue to innovate. Not everything is straightforward and clear. There is certainly a fair amount of ambiguity that remains in certain areas and that means we will need to continue collaborating. DTRA has delivered on our initiatives, but we still have work to do in 2023 to deliver on our mission. At the Annual Meeting we also shared updates for the audience to be aware of the current state of initiatives coming to life. also Importantly, we also heard from regulators from different regions about their plans for upcoming guidance, what their asks are of industry for sharing experiences, and hearing from leaders in pharma who showed up to share their organizational strategies for how they are committing to scale of decentralized trials.
Miseta: When you mention collaboration, is that between pharma companies, vendor companies, or regulators?
Lipset: All the above, along with the site community and patient organizations. There are several areas of shared challenges that are not unique to one pharma, one tech platform, or one CRO. They are shared challenges across the ecosystem. Some are new areas for DTRA, such as best practices for monitoring in decentralized trials, or how we can best integrate sensors and wearables into studies. What are the unmet needs of investigator sites that they need to see addressed for the industry to drive adoption? What are the gaps that remain around diversity and inclusion in trials that may be decentralized? We are seeing these and other new areas of interest emerging, such as the environmental impact of shifting to decentralized trials and how that can help support corporate social responsibility and environmental, social, and governance (ESG) objectives within organizations. Some of these questions will lead to collaborations and mature over time into initiatives with new solutions from DTRA.
Miseta: What are some of the remaining challenges?
Lipset: We have some geographic gaps around the world where certain regions or markets are looked at as ambiguous in terms of operating models, whether regulations, policies, cultural or otherwise. That variability creates challenges for operators at a global scale. We have unaddressed concerns from research sites that are still struggling with many of these technologies, maintaining their confidence in oversight, and making sure they have proper budget for new responsibilities. These are just a few of the areas for us to address through collaboration.
Even things like language can get in the way of adoption, and a glossary certainly helps. We had a fascinating conversation that emerged across multiple panels just around the term investigator site, which is a foundational term for many of us in the industry. In one session leaders questioned if the term needs to be modernized and if it has kept pace with existing innovations in the area. One of the regulators in attendance contributed that it is not the regulations that define the term site, that the definition comes more from the research community. It’s interesting how some of these foundational questions continue to emerge as we continue to innovate.
Miseta: At this time do companies seem to be concerned about the cost and ROI of DCTs?
Lipset: Perspectives on ROI vary from company to company. There are some that are much more concerned with near term key performance indicators and what the impact is on recruitment and retention without compromise to data integrity and patient safety. There are some that look at near-term cost implications. But many decentralized elements have a longer-term ROI, such as improved recruitment and retention rates and their associated costs. While most sponsors are not focusing on near-term cost impact, the economics of DCTs at scale will always have to be in minds of operators as we’re looking at those KPIs. Companies must ask if they are able to deploy these approaches at global scale in a way that is cost sustainable. It doesn’t have to be a large and direct cost savings, but it does need to be a sustainable business model.
Miseta: What do companies currently see as the main benefits of DCTs?
Lipset: I believe there are three levers that people have focused on. First and foremost are patient factors such as recruitment, retention, experience, access and representation. Those patient factors were part of the original value proposition for DCTs, and they remain a top priority for most organizations today. Behind that we see business continuity. We have seen the impact on patients who are unable to get to research sites for the duration of a trial due to many factors such as global conflict, future pandemics, or other environmental factors. These decentralized methods have matured into becoming a risk mitigation strategy in an unpredictable environment. Finally, companies and investors are increasingly concerned with ESG (environmental, social, and governance), corporate responsibility, and the carbon footprint of their clinical development organization. We are now in an era of using digital tools to support design and planning of our studies up front and how we might start looking at the environmental impact of the different decentralized study designs.
Miseta: Some clinical executives I have interviewed have noted finding patients who have no interest in decentralized or hybrid approaches. Are companies going to have to consider how these approaches might work in studies on a trial-by-trial basis?
Lipset: All of these efforts need to start by actively listening to patients in the disease area and in the specific geographies. Drug developers also need to listen to patients who are representative of the patient population that they ultimately want to enroll. I have been engaging with patients in diverse indications on study design for over a decade, and what we often hear is that people are looking for a certain degree of choice and flexibility in studies. That view has been supported by multiple patient surveys. The overall experience of patients at research sites is overwhelmingly positive, so the challenge we are looking to address is hardly that patients don’t like investigator sites. The challenge is they cannot always get there. We are living in a time when consumer facing tools are creating options for people. We should only expect people in clinical trials will be looking for similar options.
Thus far the way we have been deploying hybrid trials is a little different than what the true future of choice will look like. A hybrid trial might mean a patient is choosing an enrollment option where they will go to a virtual site or a brick-and-mortar site. It means that certain visits in the schedule will be at their home versus at a clinic. A study offering true flexibility is one that gives patients choice on a visit-by-visit basis based on where they are in their journey as a patient in today’s environment. While there are a few anecdotal examples of that, it’s an extremely challenging proposition to bring to life, as it requires data to be collected in different way on a patient-by-patient basis.
We will require systems in place like home health or site staff waiting at the beck and call of patients choosing which scenario they want. For that future to be realized, it might mean a lot of redundant infrastructure that isn’t always being deployed. The industry will need smarter, more predictive tools that can better understand patient needs with the same type of sophistication that Amazon brings to us in planning that I’m going to need batteries or coffee at my house in the next week. Those tools don’t exist for us today, but they will. We will move from hybrid trials the way we know them today to a future that truly offers choice and flexibility for people based on where they are in their journey.
Miseta: How much has DTRA grown in the two years it has been around?
Lipset: Two years ago DTRA was launched with 50 founding member organizations. We currently have over 130 organizations as members and have recently added the capability for individuals to join. These individuals may be parts of larger organizations, academics, or freelance individuals. Our organizational diversity also continues to grow as today we have pharma, service providers, site networks, advocacy groups, regulators, and health systems based in North America, Europe, and Asia.
Our initiatives have grown and evolved as DTRA has delivered on our initial commitments. DTRA is a global organization, so in the coming year we look forward to expanding our footprint in Europe and Asia. We want to make sure colleagues in those regions feel they have a home to learn and grow around decentralized research. We will help with awareness, education, and tools to demystify this area of research and create a consistent baseline of understanding that’s agnostic to any individual platform or study. At the same time, we need to ensure we are staying current and aware of new capabilities to create that future of decentralized trials for that pushes us beyond where we are in 2022.