Sites of the Future: How to Be Technology-Forward

As sites navigate technology changes and advancements within the industry, they have to make important decisions about what solutions to adopt and how. What are common challenges that sites face when integrating new technologies? Lilith Hayakawa Mist, Executive Clinical Research Director at Merck, raises important considerations for sites with technology implementation, as discussed in a panel session at SCRS West.

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Jimmy Bechtel 0:00

Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks is a program that allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and just to learn generally more about our community. Today we have Lilith Mist, the Executive Clinical Research Director at Merck here to share with us a little bit more about the solid foundation that her and her colleagues at the SCRS West conference laid around building the digital future of clinical research sites. She was part of a panel where we talked about navigating the digital life cycle and really what's next in terms of integration and innovation when it comes to digital technology on our clinical trial. So Lilith, we're excited to have you with us today to expand a little bit more on this topic and share some of the insights that you were able to gain from participation in that session. But before we do that, let's hear a little bit more about you and what you do at Merck.

Lilith Mist 1:16

Well, hi, Jimmy. First of all, it's wonderful to be here with you today. Thanks for having me. Like so many people, I chanced into my clinical research career by going to work for an investigator site. I was incredibly lucky to be hired at a psychiatric research site straight out of college. And I went to work for Merck as a CRA a few years later. So I've spent my entire 24 year career. Working in clinical trial operations today at Merck as executive clinical research director. I oversee the execution of all of our infectious disease and vaccine trials that are implemented within USA. So I'm part of our country operations team. I also sponsor and lead an electronic regulatory binder or e investigator site file initiative at our company, which we are very excited to be taking enterprise wide this year, which means it's now an optional site enablement service available to our sites, our partner sites, on all new protocols. And lastly, I participate in a few work streams that are tackling both questions of How do we first of all reach patients who aren't typically invited to participate in clinical trials? And secondly, how do we in a thoughtful way explore non digital decentralized trial elements like mobile clinics or retail pharmacy or other community based presences to build trust in the community and extend the reach of clinical trials? That's something I'm very passionate about. So you mentioned the digital elements and I'll mention that there are also non digital elements in the way we may be working in the future that are innovative or new for all of us.

Jimmy Bechtel 2:52

Thanks, Lilith. It's again, great to have you and really excited to dive into some of this conversation around digital change here. So again, you participated in that, in that really insightful panel at our inaugural SCRS West conference, really discussing how sites can be technology forward. So what was your general experience? Maybe we'll start there with the session and an SCRS West as a summit in general.

Lilith Mist 3:17

Yeah, generally, I was so excited to attend and just delighted with the rich and fruitful discussions on technology and innovation at the summit. As a sponsor representative, it was really wonderful to spend time connecting with sites deeply around their needs and challenges, specifically as related to technology. I attended so many sessions where I learned what technologies are important to sites, how they are using them, what the pain points are, especially in regard to proliferation of technology, which I think is a challenge we're all dealing with. So I felt like I came away having heard the site voice very strongly, and it was an incredibly interesting summit.

Jimmy Bechtel 4:02

Great, Lilith. I think that sets us up really nicely for our next question, but it was really energizing. It was a great summit on really one of the first times that all those different industry stakeholders were able to come together and talk about have candid, open, honest and solution based conversations in technology. So speaking to some of those solution based ideas, maybe you can share some of the takeaways from your session and what some of the common challenges are that sites face when integrating those technologies into their existing infrastructure. And again, Maintaining that solutions focused. How can those challenges maybe be overcome or at least put us on the right path to starting to solve them.

Lilith Mist 4:47

Yeah, for sure. There were a couple things I heard from sites consistently that came through loud and clear at the conference overall that I've been repeating back within my internal audience at Merck. First, crystal clear and strong request to include sites in making technology decisions. I was actually blown away by how many sites volunteered their time to consult on tech options that sponsors are considering, which just points to how powerless sites can feel when technology is thrust upon them with no choice. So this request in particular is something that I've been carrying into my internal conversations since my attendance at SCRS Summit. So I now have this refrain in meetings, have you asked sites how they feel about that, so that we're not making decisions in a silo. As another example, I heard how sites aren't always told what technology is involved when they choose to participate in a study. They may receive a core protocol and the indication and something about the study schema, but not some things that are actually going to be really key. To them for implementation and how their staff are working on a day to day base. So basis so pharma can do better. And we at Merck have built a slide into our standard feasibility deck to share with sites those optional services that we now offer from a site enablement perspective. So I hope in this way that we're starting to address that feedback. But I think there's still room for improvement across pharma to be really transparent during the feasibility. You know, particularly if there is going to be a new or innovative DCT or digital technology option that we're very upfront about what that is, and sharing as much specifics as we can during that feasibility phase. But, the last thing I Just wanted to say that I'm really pleased that Merck has a process established now for gathering site feedback, so I wanted to share for an example, just last week, my team was conducting user experience interviews with our sites about our chosen e regulatory platform, and I'm aware there was another team conducting a site Visit to get feedback on new technology we're considering for clinical supplies, but we really need to note is that technology actually alleviate site burden, or is it just adding another layer of complexity and workload. So those are the kinds of things we need to keep bringing to sites and asking those questions. And I'm just pleased that our teams are getting out there asking for side opinions, particularly with the site partners we work with over and over again. And then the last thing, I really did come away with a lot of takeaways Jimmy from SCRS. I heard sites saying really strongly, they want to be able to choose what technology they adopt wherever possible. So obviously, you know, sponsors can't do this for things that are some things that are set at the trial level like EDC, but for other things that we're talking about in this innovative space, e consent or telehealth or e regulatory, if a site has a chosen technology, And all our staff are trained and know it and it's compliant with regulations. Our philosophy at Merck is to try as much as possible to let sites keep doing what works for them. Because one size does not fit all. that also came through loud and clear.

Jimmy Bechtel 7:58

That's exactly right, Lilith. And one of the things I wanted to key in on that you had mentioned was just that small change that bringing the information to the sites earlier, that slide that you had mentioned that lays out some of the options that the sites have to participate in as part of that clinical trial probably will go a long way with them based on the feedback that I know you heard and that we at SCRS have been hearing around solving one of the challenges at the sites, and that's not having the information soon enough, as you had mentioned. So that's great. Again, it's something as small as just adding a slide to the slide deck probably will go a long way with the sites. And so it's great that you've been able to incorporate that. So very exciting to be able to share that with our sites as an advancement that Merck has been doing and truly something that shows we are listening to you as as as one of your partners in this process.

Lilith Mist 8:49

Yeah, I hope so. And I hope it's a jumping off point for sites to ask more questions. Oh, thanks for sharing that for us. We have other questions about what else might be involved, so that we're really in open dialogue in that feasibility and validation phase.

Jimmy Bechtel 9:03

Absolutely. Absolutely. I couldn't agree more. It's great to hear advancements being made. So let's talk a little bit about embracing innovation. So can you talk about the potential benefits and advancements of forward thinking and, and being open to adopting new technologies. And I guess further that then by talking a little bit about how sites might be able to foster that culture of innovation, we'll, we'll call it that within their organizations.

Lilith Mist 9:32

Yeah, thank you. I mean, in general, many industries are living through a period of accelerated pace and disruption, and it can be quite challenging. In any business, we can't be sticking our heads in the sand and hoping the change goes away. We are and should be thinking about how not to be left behind. We talked a little bit at SCRS about how things like disruption and upheaval, hurricanes, wildfires, political disruption. Of course, we just lived through the pandemic and all of the disruption that brought, you know, forcing us to explore new means to maintain business continuity. So business continuity is a competitive advantage, being able to keep. Working when things get shaky or unpredictable and keeping our, our doors open metaphorically to be, do that important work of bringing new medicines to patients. That's a competitive advantage. And we also talked a lot about how do we take work out of the system? Like we all know there's a staffing crisis in healthcare generally and in clinical research specifically. There's a proliferation of clinical trial work, a lot of trials being conducted and more coming in the future again with that pace of technology and innovation on the basic science side, we need to figure out how to support the trials to bring forward those new treatments that are really going to make a difference in patient lives and how can we do more with the same staffing resources. Those are innovations where I think we should be focusing our attention or some of the advantages of, of focusing our attention there. And in regards to the last part of your question, Jimmy, about like fostering a culture of innovation. Culture change is accomplished through investment in time, resources, and consistent communication, I think, particularly by leadership saying this is where we need to go. This is what we have to pay attention to. When you have limited hours in a day, we want you to spend some time working on it. This and that can be hard when we all have so much to do, and it's a pretty fast paced industry. So, as leaders, we have to reward risk taking, and we have to make time for people to think strategically about the future and the ways we want to be working in 5, 10, or 20 years. That's certainly challenging, again, with everything on our plates, but we have to keep the focus on it, and again, reward people who make time and try new things.

Jimmy Bechtel 11:54

That's great. Great sentiments there, Lilith. Lilith, I think maintaining that positive... Outlook and realizing that this is the direction that we're heading as an industry and be willing and open to providing two way communication with your sites and your sponsors and zeros, whichever side of the fence you're on when we're listening to this is a really important way for us to again instill that culture. So thank you for sharing those thoughts. How can sites determine then which solutions are most suitable for their needs and goals when they're looking at adopting some of this new technology or bringing it into their processes?

Lilith Mist 12:36

Well don't do what happens when I go shopping at Costco. That's what I'll say first. When I go shopping at Costco without a list, it's a disaster. I go in to buy staples and core needs, like, I don't know, cereal and rice, and come out with a flat screen TV when my current TV works just fine, and a new inflatable kayak for my kids who don't kayak, but I think they might like to learn someday. We all know we've done it. It's overwhelming right now. The number of new choices and directions that we could take in terms of technological platforms or new things to try. And I think sometimes tech is proposed as a solution, but we have to be critical about whether it offers substantive advantage for advantages, for example. Is a video call always better than a phone call, or does a phone call meet most of your needs? So, thinking about this, what's the opposite of the Costco Impulse Buy experience? Here I'll say, just being very thoughtful is the right place to start. What are your staff pain points? Who in your organization either already has the expertise or has the right skill set to build expertise at your site to evaluate the service offerings. So starting from the pain point, what problem are we solving from? Who is the team that we're pulling together to address and establish an infrastructure for evaluation that includes all your stakeholders and particularly the voices of the end users, right? This comes back to that feedback that sponsors heard at SCRS, which is please involve sites. I think at the site level, it's please involve the end user evaluate any. Technology platforms or offerings against your site's particular needs and pain points, right? So where are your staff frustrated? What's wasting their time or decreasing morale or keeping them from the critical work of engaging with patients, right? That's what this is all about the work that we do. So that's where sites and sponsors should focus their efforts. And one of the great things about the site driven solutions is a site can pick a solution that works for them. And we as sponsors, I think, should be looking to sites to figure out what works for them and take their lead. Like if I try to pick a solution from the sponsor side, it has to work in multiple regulatory environments and maybe across the globe. But sites can be really focused on their specific needs and what's going to work in their local environment.

Jimmy Bechtel 15:04

Exactly. Understanding taking that step back as a site and doing the necessary steps to assess. What do I need? What's going to work well for me? What isn't going to work well for me? What do I need to do? What do I not need to do to prepare for this? So many questions that the sites can ask that you that you hinted to as part of that process for assessing which solutions are suitable for them. So thank you for sharing those valuable insights around what can be done there. Well, if, as we begin to, to, to close our conversation here, let's talk a little bit about the future and, and, and again, looking ahead at what trends and advancements that you might foresee that will impact how sites adopt and utilize that technology on their clinical trials.

Lilith Mist 15:52

While many of the sites at SCRS were very technology forward, right, they came to SCRS because they're interested in this topic, I also heard some anxiety from sites that if they didn't embrace decentralized trials or digital innovation, despite all the ambiguity and challenges that remain in those spaces, that they might be left behind. So I want to speak a little to that anxiety. What I and my team look for today during site selection is still has to do with the core aspects of clinical research. Quality PI oversight, overseeing patient safety, ethics and ICHGCP compliance, the training and experience of the staff doing the trial, and engagement and access to the people who are affected by the disease under study. Like that's at the center of what we do and sites are at the center of our clinical research infrastructure. And a site core competency isn't Proficiency with a wearable or a digital. It's recruiting eligible patients and conducting the trial in a compliant manner that produces clean, reliable data. So I want to say first that I don't see that core competency changing. And I told sites at SCRS, I think that's worth its weight in gold, right? Skilled, experienced staff who know what they're doing in the clinical research environment. But I can't imagine a few things in the near to midterm future becoming a bit of a competitive advantage. We talked about keeping the doors open during disruption, and we talked about staffing pressures, right? With all the pressures on staffing trials, any innovation that is going to take work out of the system could be of competitive advantage to the research staff and to the research site. And for me, one of the big opportunities that I'm thinking about is eSource. To E. D. C. feeds because I don't think anyone imagines that in 10 to 20 years, transcription and C. R. A. verification of that transcription are still going to be the preferred process, right? So today we pay one person to record blood pressure first on one screen and then on the second screen in the E. D. C. And then we pay a second person the C. R. A. to see that that transcription was complete and without errors. So that's work. That I think philosophically, we all understand could be taken out of the system. The question is, how soon is an industry? Can we get to new ways of working that involve data feeds instead of manual transcription and manual quality control? And aside from helping research staff. Get work out of the system. The other thing I'm really thinking about are the big questions about how we get research opportunities to the front line of patient care. That's where DCT or digital innovation starts to become interesting to me. it proved to be exceptionally more difficult during the pandemic than we might have imagined. Like, there was all this tremendous will from the public to innovate and find new treatments for treating COVID, but we still really struggled to close that gap between our existing research infrastructure and the front line of patient care. So sites that can innovate to close that gap, and I want to emphasize that infinite Innovation might not be technological or at least not exclusively technology based. It might be partnerships or something else, but increasing patient access to clinical trials is something that's going to benefit not just patients, but sites and our industry overall in the years to come.

Jimmy Bechtel 19:13

Lilith, that's a really positive, great message to end us on. I appreciate you bringing in something specific around what we can see from a site perspective from, like you said, easing that burden on the site. And I would agree that the, the ESource EDC synchronization integration, I think is a really positive place for us to look as an industry and something we've been talking about for a long time now. So it'll be it'll be great to see the first organizations that really tackle that in an effective way. But also then, of course, the answer you gave around the patients and what it means for them and how we can make their lives easier through digital technology. So I think that's an important perspective for us to keep as we continue down this path. path of implementing digital technology onto our clinical trial. So thank you again for being here with us. Thank you for sharing some of those really valuable insights from not only the session, but also from your view as an individual immensely ingrained into the processes behind digital innovation and technology implementation of our clinical trials. Again, thanks for being with us.

Lilith Mist 20:23

Thank you so much for having me, Jimmy. I mean, it's obviously a really exciting but challenging time, and I'm really happy to be here with you today talking about this topic. Thanks again.

Jimmy Bechtel 20:32

Absolutely, absolutely. And for everyone listening, make sure that you consider registering for our upcoming summits being held throughout the year by visiting the summit page on our website, myscrs. org. While you're on that website, you might as well also be sure to check out other SCRS publications like SCRS Talks that we have created for our community in the publications section. We appreciate everyone's participation in listening to today's program and look forward to having you join us. for more great content coming out very soon. Thanks again for listening.