Decentralized Trials and Research Alliance

It is always a great pleasure to engage with clinical trial innovator and thought leader Craig Lipset. We asked Craig to join the People Always, Patients Sometimes podcast to share more information about DTRA, which stands for Decentralized Trial and Research Association. As an industry, we have embraced more fully the idea of serving patients better with a decentralized clinical trial. As we bring the corona virus under control, it's important that we don't become complacent and return to business as usual. Give a listen to the podcast and I hope you'll join us in declaring there is no going back.

Janet Kennedy: (00:43)

It is always a pleasure to welcome Craig Lipset to the podcast. He is a man that really needs no introduction, but I'm going to give him one anyway. As the former head of clinical innovation and venture partner at Pfizer and on the founding operations committee for TransCelerate Biopharma, Craig is recognized as a leader at the forefront of innovation in clinical research and medicine development. He is a frequent speaker at healthcare and pharmaceutical conferences, and he has also led the call to innovate and recognize that there is #nogoingback to improve clinical trials. Today though, we're talking about DTRA, Decentralized Trials and Research Alliance. Welcome to People Always, Patients Sometimes Craig.

Craig Lipset: (01:29)

It is such a pleasure to be back with you, Janet, thank you for everything that you're doing to give so many voices the opportunity to share.

Janet Kennedy: (01:38)

Oh my great pleasure. This is always a learning opportunity for me. I am not a journalist, but I do play one on this podcast and I get to ask all the air quotes, dumb questions, that I'm sure a lot of people want to know about, but sometimes they get caught up, that something's already rolling ahead. And they're like, did I miss it? Did I have a fear of missing out what's going on?

Craig Lipset: (02:00)

Absolutely. You know, there's so many different ways for people to stay current and stay connected. And you know, sometimes we have to hit a lot of different channels to make sure that everybody gets that opportunity to, to connect and to stay current with what's going on out there.

Janet Kennedy: (02:18)

So on the connection aspect, we obviously have been dealing with the pandemic for gosh, a year now, and this time last year we were preparing for the last in-person event, which might've been SCOPE, and then suddenly things spun out of control and we were all sent home. I think things have changed a lot for you as well. So I'm curious, being able to look back a year over how things happened in 2020, what do you think has really impacted clinical trials with folks being sent to their rooms?

Craig Lipset: (02:56)

You know, I think a lot of people will expect me to say things telemedicine and remote monitoring and risk-based monitoring. I would say that the thing that's really impacted us is willingness to adopt. And what I mean by that is so many of the things that have been so important for business continuity this year, the things that have kept our trials running weren't solutions that had to be cooked up in a lab in the year 2020. Most of these were solutions that already existed. They were just struggling for adoption, usually struggling for adoption because we operate in a very risk averse environment. But when the risk changed in the environment and all of a sudden, some of these things that might've been viewed as risky, suddenly became risk mitigation, they became the way to maintain business continuity. 2020 became a story about adoption, about so many great solutions that had been at our feet that had been at the doorstep suddenly seeing their moment in the sun when study teams and organizations were able to pick them up and bring them into their studies and bring them into their portfolios. And that's an exciting way for us to now get 2021 going, because now our organizations have seen that we can bring these different things to life, whether it's risk-based monitoring decentralized trials or whatever other solution your listeners were able to bring into their organizations to keep their work going.

Janet Kennedy: (04:23)

Well I think that's an interesting point and you've been fortunate in that you've been able to sit a little bit in the cat bird seat because you've had an opportunity to participate in a lot of virtual conferences. You advise a number of companies. So you've been able to get feedback from a lot of different sources, as opposed to, if you were solely ensconced at Pfizer, you might not have access to the kind of information I'm thinking of. So here's my question. Do you believe that all companies, saw that opportunity to innovate and to accept and to accelerate? Or do you see that there's been a, sort of a separation of the wheat from the chaff and there are the companies that already had a innovation growth mindset, and then there are the folks that are just struggling to keep up?

Craig Lipset: (05:11)

I think that in that April, May, June timeframe, a lot of organizations were all in the same boat. They were all trying to scramble to keep their portfolio going. They were rushing to introduce whatever countermeasures they could to keep patients being monitored, keep drug supply flowing, and keep capturing data. So that studies didn't wind up futile. But, Janet, I do think that we start to see some separation when we look to the latter half of 2020, because in that latter half of 2020, then we start to see that there are some sponsors out there that are starting to commit to some of these changes they're putting in place, new resources, they're relooking at some of their SOP and processes. They're expanding their vendor and partner lists some really starting to rethink how they write protocols and introduce some new training. These are the companies that are really starting to show commitment. They're really looking at the things that were adopted earlier in the year and being thoughtful about what's needed now to instantiate these and make them a part of our organization going forward. And that's different from some others that just maybe haven't been able to step forward to make those kinds of organizational commitments yet because they're hard.

Janet Kennedy: (06:35)

Well, not only, they're hard; you may not even have the environment within your company that can embrace that kind of change and thought process. You really do need leadership that is willing to invest in that kind of information and that kind of structure, those kinds of individuals.

Craig Lipset: (06:53)

Absolutely right, Janet. If there's one thing we saw in 2020, it's that these new approaches, well, they don't need special regulatory permission. Yes. The FDA produced some really important guidance for the industry about running clinical trials during the pandemic. But I encourage people to take a close look at that guidance. They didn't lower the bar on what technologies or approaches to introduce. They just said, use them and use them thoughtfully engage with your regulatory reviewers. And so from a regulatory perspective, these solutions were available; from a technical perspective, they were available. What does that leave? Exactly where you're pointing - culture, and our organizations ready in terms of their own internal culture and receptivity and willingness to change, or is it the culture that will ultimately stand in the way of those organizations being able to commit to and adopt these new approaches that were introduced last year?

Janet Kennedy: (07:51)

I imagine that's a big part of what you do as a consultant is helping companies revision how they look at the growth of their company and expanding their capabilities through innovation.

Craig Lipset: (08:04)

You know, Janet, I can only help organizations that are ready to be helped, but when they call, I'm certainly happy to be there. And mostly what I do professionally, whether with pharma companies, tech companies, or with others, is to help them make their strategies fabulous. And to help them make their implementations resilient. I can't fix the culture on my own. I can't show people solutions that they're not ready for. And so, you know, I can really only come in if leaders are ready to commit to these areas.

Janet Kennedy: (08:39)

So you had a lot of time on your hands where you might've been traveling on airplanes, going places, and you obviously found a nice little hobby on the side where you decided to get together with some other thought leaders and launch a new initiative, the DTRA, the Decentralized Trials and Research Alliance. So I'd love to know the backstory. How did that come about?

Craig Lipset: (09:04)

With all of that free time? Really Janet. So, it's interesting. DTRA is planning actually preceded the pandemic. It dates back to just prior to the pandemic when a friend and colleague Amir Kalali, who is well known in the industry from his time at Quintiles leading the neurosciences, and his time as the leader for the CNS summit Amir reached out and that he was exploring some different convening opportunities around decentralized. And we both appreciated that the world didn't need another conference on this topic. But when we have talked about decentralized in different meetings and events, there was always something left on the table. There was something that would come up at every one of those conversations about an opportunity to make the field better together. That was then left behind when that conference ended. And so we started to explore together what could be really sustaining and help to change this field.

Craig Lipset: (10:02)

And then, the pandemic emerged. Which, in many ways, amplified everyone's attention around decentralized, but also was pretty distracting in terms of people needing to be heads down and keeping their portfolio going. And so while there was a lot of interest from a lot of my network around coming together with the DTRA, we did have to push some of our plans out to later in the year and give people in their organizations time to make the adjustments that they needed to, internally. By the end of 2020, in early December, we were ready to go live. And so made a public launch of DTRA, the Decentralized Trials and Research Alliance. We had over 50 founding organizations as members. These were groups that really took a chance with us believing that there would be a community that came together to try to make adoption of decentralized research, easier and help drive the scale that we know as possible, but it's hard.

Craig Lipset: (11:04)

And so with that, we launched DTRA. Now we're at about 85 members. I think we'll probably be at a hundred member organizations and over the next month or so, we keep posting those updates on LinkedIn and Twitter. So what is DTRA? There's really two aspects to the decentralized trials research Alliance that I speak to. One is the work that we're doing together. The initiatives that we're taking on, and the second is the network and the community that we're creating that can support B2B transactions and raising more awareness and activity in the field. For the initiatives, our leadership council, our members, defined four priority areas together. The first is around definitions and how we agree on archetypes and key performance indicators to help reduce some of the tower of Babel in this category and help make sure that we're talking about the same things in our conversations with one another.

Craig Lipset: (12:06)

The second area has been around best practices considering that our members, whether pharma, whether CROs, tech companies, site networks, advocacy groups, and the FDA themselves, our members have been involved in most all of the decentralized research studies that have gone out in the last few years. What are the learnings, the best practices that we can identify together to help make implementation easier? The third area for us is themed around education, because so many of us get stuck needing to bring our organizations along or other stakeholders, like investigator sites or patients and their caregivers. What type of educational resources can we begin to aggregate and share, and in particular, use data and evidence to drive that education? As an example, we all talk with enthusiasm about the potential for decentralized research to improve diversity in clinical trials. But where's the data and the evidence to back that up?

Craig Lipset: (13:10)

We believe that by having a multi-stakeholder initiative in a nonprofit space like this, we'll have the opportunity to gather the data and evidence across our members. A fourth area, the fourth priority for us is around removing the remaining obstacles that stand in the way to meaningful adoption. And so those might start to include topics like interstate licensing or global regulatory variability, or other priorities. that our members are working together right now to identify and prioritize. Now I know firsthand from my time at Pfizer that we are not the only initiative collaboration consortia operating in this environment. And in fact, we have identified and begun to engage with over a dozen different initiatives, consortia, collaborations that cover a number of different topics, but might have a work stream, a taskforce, a work group that's looking at decentralized trials together and trying to solve a specific problem.

Craig Lipset: (14:12)

We've begun to reach out to each one of those organizations and have been really well received in our call for transparency and collaboration. And by that, what we're looking to do is pull together the overall roadmap across the different collaborations in this space, because when it comes to decentralized trials, it's the only thing DTRA cares about. It is our sole priority. And so we're very well positioned to help show our members and others what different work is already happening here. Make sure there's no redundancy. Make sure that there are handoffs when it makes sense. And Janet, I mentioned earlier that there are really these two areas; one around our initiatives, and the second is a bit the leans in more around network. We realized that our members are the buyers, the sellers, the implementers of decentralized research. Our initiatives are very specifically a non-selling zone there to get work done together.

Craig Lipset: (15:09)

But people in our community want to know about the capabilities of one another. It might spark business to business collaboration among different tech companies or tech and service providers or opportunities to engage with sponsors that might not have otherwise known of certain capabilities. We're also starting to explore opportunities to help some of the younger companies in this category with access to capital, and what ways we can create showcases for investors that are very interested today in decentralized research, and make sure that the spotlight is shown on those that are growing new capabilities here. And so whether for these initiatives or for these network opportunities, or a little bit of both, that seems to be what's drawing this community together.

Janet Kennedy: (15:53)

Gosh, have you said this before?

Craig Lipset: (16:00)

Maybe in my sleep. I'm sure my kids are sitting in the other room saying, "Really dad? Again?"

Janet Kennedy: (16:07)

Okay. So I have a couple questions. I'm curious about the membership. You said you're hoping to grow to about 85 to a hundred members and maybe beyond that, but that sounds like it's all pretty corporate members. Is there an opportunity for individuals to engage in this?

Craig Lipset: (16:25)

That is a fabulous question, Janet. And right now our members are organizations. They can be corporations, they can be nonprofits. We have a number of advocacy groups, and obviously we have the FDA and our opening engagements with other regulatory agencies. The idea of individual members is something that our leadership and our board have been very actively exploring. Individuals might be between gigs. They might be independent contractors. Maybe they're just great advocates for this field, that want to grow their career in this direction, but their current employer isn't a member because it doesn't align to their employer's goals. We are finding ways to engage with these individuals. Today, those might be roles that are based a little bit on sweat equity, where some individuals want to step forward and help to manage and lead some of our initiatives and work streams. Going forward, though, we are going to be looking later this year for other ways, to open our doors for individual members. And so I would encourage those who are individuals whose organizations might not be members today to visit dtra.org and click to sign up for more information, so that you'll be on our email list. And as new opportunities emerge, you'll be right there among the first to see them.

Janet Kennedy: (17:47)

Obviously just the concept, a decentralized trial, I would assume, that its foundation is 'because that's what's best for the patient'. How are patient advocates and the patient experience part of the DTRA planning?

Craig Lipset: (18:04)

While in 2020, a lot of implementation had to be rushed to try to salvage and maintain studies, in general, our clinical research community is eyes wide open today to actively including patient input and insight from day zero of the earliest plans, whether for a protocol, or if they're smart, for a new technology they're looking to implement. And so for that reason, we wanted to make sure from the very beginning patient voices were an active part of our community. Two of our earliest member organizations, the FasterCures TRAIN Network and the Genetic Alliance joined in many ways, because they're not representing a single disease, but represent a community of different disease specific advocacy groups. And so in each of those instances, while that is a seat of one organization, that one organization is disease agnostic and includes constituents across a broad range of different therapeutic areas. Now, as more patient groups have been reaching in, many of them are actively offering to help serve as a channel for patient input and insights as DTRA initiatives and other priorities start to identify, be they educational needs or other areas to go after. I think we're developing a very nice stakeholder base of patient groups that will be there by our side and help to serve as a fresh channel for getting patient input into our work.

Janet Kennedy: (19:36)

Is there a concern at all that if this is primarily fueled by and funded by for-profit organizations, even though DTRA is a nonprofit organization, that there might be an imbalance of the size of the voice?

Craig Lipset: (19:53)

It's a very fair question. Right now, every organization, whether for profit, nonprofit, whether service provider, tech provider, sponsor or otherwise, every member has one seat in one voice in our leadership council. But to your point, we do want to maintain fairness and equity and the different voices that are out there. I think that we have enough active leaders in this organization that are keenly aware of thoughtful of, and sensitive to patient voice today, that well, shall I say in most cases when the patient voice is raised, most people are smart enough to take a step back and make sure that voice is being heard. And if they don't, they're probably going to hear about that from their peers today.

Janet Kennedy: (20:41)

Excellent. I am curious about how does a company, a member actually engage? Are you having monthly zoom calls? Are you actually working via email? How do you plan and implement some of the programs that you're doing?

Craig Lipset: (20:59)

Every member organization has a seat on our leadership council, which has a quarterly business meeting. In these business meetings where we're reviewing the status of the various initiatives and other work that may be happening. We also have a quarterly community meeting for that leadership council. This is a bit softer. It's not covering the hard topics such as what initiatives progress and status is looking like. But in contrast, these are a bit softer topics that our members have flagged to us as being important to them. One great example there is exactly where you started this conversation, Janet, around culture. Are there tactics that different organizations have been able to introduce in their organizations, large or small, that have been particularly successful or unsuccessful that we can use this community to help share and propagate with others? As I mentioned, in addition to our leadership council, we do have several initiatives that are underway and those initiatives will meet much more frequently. As they get going, they're meeting weekly. And as they get moving that cadence may back off a bit. But right now we're very much in the prioritization stage. It's a pretty busy time right now, as these initiatives are getting going. And so the cadence is a bit busier than it probably will be as we move into more of a steady state.

Janet Kennedy: (22:26)

So the pandemic has gone on long enough and will continue to go on long enough that anybody who was hoping to wait it out, I'm sure has learned that, to their detriment, that they were slow off the starting blocks. I assume now it's sort of full steam ahead for the concept of decentralized trials, or are you still feeling that there are folks hoping that the good old days will be back again?

Craig Lipset: (22:53)

You know, Janet, I think that our community is like any other and we have a distribution of individuals. I think that we have individuals in all of our organizations at the far right of the adoption spectrum; they want to be the first, they want to embrace the new. I think then we have a bolus of colleagues that are receptive to doing the new, if it feels safe, and if it feels supported. we have others that may be a little more indifferent. And then we'll always have that tail of the other end of the continuum who are very comfortable that really don't want their cheese moved, and well, to be honest, are perhaps most likely to trade out, given how dynamic and how much change occurs in all of our organizations every year. You know, I often think about, Janet, the Ted Talk with the video of the dancing man.

Craig Lipset: (23:45)

And if folks in your audience haven't seen this one after the podcast, they should go Google this one up because it's a great voiceover of a story of a concert taking place on a hill. And in this video, you start off with a bunch of people that are listening to the music, sitting on their picnic blankets. And then there's a guy who just gets up and starts dancing. Well people are looking at this guy, and he's the only one standing there dancing. And you know what you're probably thinking - he's looking like a nut. But after that, there are two or three other people that start to get up and dance. Once they do, it validates for everyone else on the hill. Now it's not just a story of one nut dancing by himself, but it's a story of a small crowd that is much safer. And once that happens, it's that rapid tipping point. Everyone else on the hill is now off their picnic blankets and up and dancing. And so I think about it that way with so much of our change in this space. There'll be some people that don't want to get up and dance ever, but once it's made to feel safe, once there's just a couple that are getting up and making it happen, the rest of our community does step forward. They will be up there dancing as well.

Janet Kennedy: (25:04)

Well, on behalf of a dancing man representative, I believe that that is an exciting place to be - out there, by yourself, trying, doing what feels right, feeling that emotion of just doing the thing that really is right for you. And when other people join you, that just makes it that much sweeter.

Craig Lipset: (25:29)

Sometimes it takes time. Sometimes you might feel like you're out there dancing for a while, but I totally agree with you, Janet. We are so fortunate to work in this industry. Our community does amazing work, developing medicines for patients with unmet medical needs. But even within this space, we know there's so much more we can do. And we know that there are things that we can do just because they are the right things to do. And so a lot of us do, you know, get up and dance and take that chance. And sometimes it takes a little while, but if you're doing the right thing, others will get up and dance with you. It just may take a little time.

Janet Kennedy: (26:07)

Absolutely. Well, I would love to get more people involved in DTRA and also following the news that you're going to be sharing. So tell folks a little bit about how to find out more about Decentralized Trials and Research Alliance.

Craig Lipset: (26:22)

Three ways for folks to do that. For those who are social, the first two ways are LinkedIn and Twitter. We're really committed to keeping content flowing, to helping to serve as a trusted news and resource for folks on LinkedIn and Twitter about activity in the decentralized trial space. And then finally, check out dtra.org. If you're interested in learning more, either about organizations participating or just yourself staying current, go ahead and sign up there to stay connected with DTRA.

Janet Kennedy: (26:55)

Thank you so much for sharing that, Craig. I had a lot of questions and you were very patient about answering all of them.

Craig Lipset: (27:02)

You're fabulous Janet. Thank you, and thanks to your audience for spending some time this day.

Janet Kennedy: (27:07)

So if you want to find the link to the dancing man video, or of course, a lot more information about DTRA, please go to spencerhealthsolutions.com and you will find the post of this podcast on our website, under podcast. And we'll have all the links there as well as the links to find Craig in social media as well. Craig, thank you so much for joining People Always, Patients Sometimes.