Interview with DHRA Co-Chair Craig Lipset
Decentralized clinical trials are seen by many as the future of clinical research, but there are still a number of challenges that are still impeding widespread adoption. To help overcome these, and “accelerate the adoption of patient-focused, decentralized clinical trials”, the Decentralized Trials & Research Alliance was set up. Pink Sheet covered the creation of the alliance here.
We spoke to Co-Chair Craig Lipset to find out more about the association and more broadly the implementation of decentralized and hybrid trials during COVID-19 and beyond.
What is the Decentralized Trials & Research Alliance (DTRA)?
"The DTRA is a non-profit collaboration exclusively focused on driving meaningful adoption of decentralized research methods. Our membership is extremely diverse - we have close to 100 organizations as members that include regulatory authorities, pharma companies, CROs, technology companies, niche service providers, site networks and advocacy groups, as well as now a number of healthcare organizations. So you see in our members such a diverse range of skills and capabilities to bring this model to life and to bring it to scale."
Why is collaboration so important for the adoption of decentralized trials?
"Decentralized trials epitomize the saying ‘if you want to go fast, go alone. If you want to go far, go together.’ Organizations have plenty of work to do on their own - they need their own enterprise strategies, they need to on-board tools and solutions that work for their portfolio. But there is only so far that organizations are able to go alone - there are challenges to meaningful adoption that transcend any one organization or company. I've lived that life myself - I was the Head of Clinical Innovation at Pfizer, I helped launch Transcelerate and other initiatives, so I've seen first hand where some of those barriers are and when it comes to decentralized research, the barriers are real.
Our members have been actively defining four priority areas for the DTRA on which to focus, and are now in the process of prioritizing a portfolio of initiatives based on those priority areas that will help them drive adoption that they are all looking for."
What do you see as the main benefits of decentralized trials?
"There are a number of benefits that certainly some organizations are realizing and some are aspiring towards. These are very much based around participation with the goal of improving access, experience, convenience and diversity. If we can remove some of the burden associated with research participation, can we help drive more participation, more engagement in diverse communities that we're not able to access either because of geography, socio economics or otherwise, in the hope that it will expand the population who are able to access research as a care option.
Others look at decentralized trials as an opportunity to get closer to the real world. To move our trials outside of our ivory tower research institutions and help expand places where data is being captured.
Coming out of 2020, some will look at decentralized research as an important risk mitigation strategy because of the unpredictability of our environment. With the need to have risk mitigation strategies, many decentralized research tools became the most important counter measure people were relying on last year."
What impacts has COVID-19 had on the adoption of decentralized trials?
"Certainly in the Spring and Summer of 2020 there was a scramble to adopt many of these approaches simply for trial continuity because trials were at risk in terms of our ability to get the study drug to participants, to monitor appropriately for safety, and to collect the endpoint data that we rely on and are the reason we are doing these studies in the first place.
By late Fall, we started to see the community begin to shift towards more long term thinking and planning - starting to make more organizational commitments around decentralized research. Companies began relooking their SOPs and training, looking at their vendors and partners, developing more enterprise strategies in these areas. That signal is I think the most reassuring from last year. It is one thing for study teams to write protocol deviations and SOP waivers during a pandemic, but SOP deviations and waivers inherently imply that you're going to bounce back to your old ways of doing things - they are temporary by design. But by late Fall we were starting to see these commitments come in place - dedicated resources, teams being formed - that I think has been a very promising sign for sustaining change."
What are the biggest challenges to adoption of decentralized trials that still need to be overcome and how is the DTRA looking to overcome them?
"We do need to build a body of evidence to help bring more organizations into the tent and to join in embracing these new approaches. The DTRA is certainly looking to help catalyze some of that evidence aggregation across those that have been implementing decentralized trials.
We struggle with global regulatory variability and so for organizations and research Sponsors who look to run studies around the world concurrently, having ambiguity across borders stands in the way of sustaining adoption.
I think one of the greatest opportunities for us going forward will be around how we shift our mindset from writing protocols that differentiate between visits in the clinic and visits at home and begin to create options and choice for individuals and how they participate. It is what we're used to as consumers and as people in the year 2021. We can go to the grocery store or we can order delivery to the house - we have choices in how we engage and I think that is, going forward, the aspiration of many in this community. Our tools and our protocols don't necessarily support that today, our endpoints don't support that in terms of ways that we measure things and people, but they're heading in that direction for sure."
What's next for the DTRA?
"By April we will have our initiatives prioritized and we will start to launch teams with our members to address some of the specific challenges and deliverables that they've identified. We are building a balanced portfolio so that roughly two thirds of our work will have read outs in the next 12 months. Allowing us to have quicker wins that can make an impact today, as well as perhaps more challenging longer term bets.
We'll also start to introduce different b2b collaboration opportunities for members and others by later this year, helping to make sure that capabilities are known and partners can be found. And not just among pharma sponsors and technology providers, but whether it is service and tech companies working together, investors finding opportunities here, there's a lot of great b2b that I think we're well positioned to help catalyze."
In April we caught up with Craig again about how the organization is attempting to "accelerate the adoption of patient-focused, decentralized clinical trials”. Read that the follow up questions on the next page.
Last time we spoke you were working on initiatives, how is that going?
"We have confirmed 12 initiatives that align to our four priority areas; definition, best practices, education and removing remaining barriers. For each of those we have three defined initiative for which we are now starting to populate initiative teams with our members. Within the next month we'll be able to communicate what these initiatives are.
We will identify both subject matter experts to work on these initiatives from the different companies, but also some co- leads from our member companies who will be the champions for those different initiatives. In the coming months, we will then begin to see some of the voices from members of DTRA speaking about their initiatives and their work.
There may be some information that is competitive that they have to hold back, and that's understandable, but there is so much that people want to be able to share. They are hungry for sustaining platforms, so certainly from a best practice perspective, having a sustainable model for how organizations can share best practices with one another is essential.
In almost a Wikipedia-like way, we don't want just a freewheeling posting of anything that one person thinks is a best practice - there does have to be a little community vetting around this. Best practices in our space are highly dynamic so we need a dynamic digital space for these to continue to grow and evolve based on the experiences that organizations are having right now."
You also spoke of quick wins that can make an immediate impact - do you have any examples of that yet?
"What I hear from some members, and particularly in pharma, is a tremendous sense of urgency to leverage the momentum for change that is here with us today to establish commitments in the organization. Organizations get distracted and these leaders want to make sure that there is a version 1.0 established in their organization. Even if it's not perfect, they will always then get 1.1 and 1.2, but if they don't have that version 1.0 they will lose this momentum.
Therefore, roughly two-thirds of our initiatives will have some readout next year. We are very committed to be able to give back something not just to our members, but to the community next year."
