Site-Centric Strategies: Merck's Approach to Collaboration

This special episode spotlights Merck's site-focused initiatives and work that contributed to its designation as the 2023 SCRS Eagle Award sponsor of choice. Jennifer Sheller, VP & Head of Clinical Sites, Data Management & Quality discusses Merck's commitment to increasing trial access, supporting the next generation of research staff, and improving site-centricity. 

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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 to just learn more about our expansive community. Today, we have Jennifer Scheller, the vice president of clinical trial sites, quality and data management with Merck here to share some insights about how Merck has recently addressed some of the industry challenges that they've heard from sites. This conversation is very timely because Merck is the 2023 recipient of the SCRS Eagle award, highlighting the fact that they are a sponsor of choice that sites have picked, the sites have spoken and voted, and Merck was the recipient of this year's award. So Jennifer, it's great to have you with us here to share again those industry challenges and how Merck has addressed those. So we'll start things off, if you wouldn't mind, a little bit of an introduction.

Jennifer Sheller 1:06

Sure. My pleasure. Thanks for this opportunity and thanks to sites out there for your vote of confidence and your partnership and clinical research. We're very humbled and inspired with the Eagle Award this year. So, for my background, I have been working in clinical trial operations to some capacity over the past 25 years. I started. In the industry, out of school, sort of stumbled upon this career and lucky me, I started as a junior CRA and then did various roles in country operations and global trial management, data management and spent a lot of time on sponsor inspections with different health authorities. So I've garnered a lot of experience and joined Merck in 2017, so over six years ago. And now I'm responsible for our strategies and support for our clinical trial sites, as well as, as you highlighted our overarching quality approach and data management.

Jimmy Bechtel 2:03

Great. Thanks, Jennifer. It's again. Great to have you here and congratulations on receiving that Eagle award. Let's start things off by having you maybe elaborate on some of the initiatives that Merck has undertaken to support sites in increasing, I guess, trial access and promoting diversity and inclusion in our clinical trials. We know it's, it's a important aspect of the modern clinical trial, so I'd love to hear again what Merck is doing in that space.

Jennifer Sheller 2:30

Sure. And this is certainly a priority for us. It has been a priority for us, not just because the FDA, you know, issued some draft guidance and requirements coming out. But, you know, firstly, I just want to highlight we stood up a dedicated organization of diversity program leads to really build our internal expertise and advance our ways of working beyond, you know, traditional trial support activities. So we have a dedicated team in place. And they're really working across the ecosystem to bring different tools and support to our sites and our teams to, to really approach things more at the community level and, and different ways where we know there's known barriers for trial access. So, some of the ways that we are directly supporting our sites. We know that travel and expenses are often a challenge to get access to clinical trials, you know, beyond awareness. So we have instituted this year from our global trial operations team. We have lift transportation for all U. S. patients. patients and trials. That was something that we brought on board this year. And we also offer ClinCard which is a tool to give patients to reimburse them for their expenses. And the idea here was to help have timely reimbursement for patients, but also take a lot of the administrative burden off of busy study coordinators and site staff. We've also worked to build dedicated relationships with sites that are supporting communities and particularly underrepresented racial and ethnic group communities. And we built sort of a network of of centers of excellence, and we were working with those sites to, you know, understand more how we can support more directly some of the community activities and. One area of support that we've begun to implement is a research navigator role, which is really a role dedicated to making that connection in the community of trial awareness and also, you know, answering questions, building trust and and connecting people and patients to clinical trials. We know we can't just keep putting more and more tasks onto busy study coordinators and principal investigators. So this is a new role that we've implemented this year and continue support and grow this even, you know, beyond our, our diversity centers of excellence. And you know, trial teams are busy. We wanted to provide a way where we were providing education and sharing best practices across sites. And from members of the community, we stood up a community advisory board, and we have lots of engagements, you know, with patient groups, and we wanted to provide a forum outside of the busy trial space to, bring sites together to provide best practice sharing, and also to share what we're offering to support sites, because it can get a bit overwhelming. So every quarter, our team runs a webinar for U. S. sites. It's optional. It's if people want to attend, and we've had great attendance. We have several hundred attendees per webinar, and we have guest speakers in from different sites or community leaders just to again, share and educate. And then we also share what we can do to provide support for sites, and we have lots of materials out there to educate on trials. We give each site a diversity inclusion clinical trial toolkit which provides brochures to help sites educate patients on clinical trials and, and also to provide tools for sites on ways that they can be more, more culturally aware. And our next webinar is focused on unconscious bias and, and so we're really just trying to tackle it from the trial level, but also more broadly in the ecosystem and just a few other areas. I'll, I'll briefly mention community engagement has been a big part of our strategy. So we've developed an agreement and a partnership with blackdoctors. org to have very targeted educational series. And trial awareness. We have another partner coming on board very shortly, who's going to do targeted outreach and different communities across the U. S. And then we have this fantastic mobile unit that's out there at one of our sites, and they're using that in the community. I know we've had a lot of sites raise their hand to say, when can I sign up next? So we've just gotten started with one of our sites, and it's been really great pre screening and trial awareness activities using that mobile unit and engaging in the site community.

Jimmy Bechtel 6:46

Wow, Jennifer. I mean, it's incredible to hear so many different aspects, right? It's tough to pinpoint one as being maybe better than the other, but the multi pronged approach that Merck is taking is really, really great to hear. And what I think is really important because we hear it from sites all the time is that it's not necessarily just that trial by trial opportunity to increase and awareness for clinical trials and awareness for our diverse patient populations. It's an ecosystem challenge. So that's awesome to hear the again multi pronged approach that you're taking there with not only trials, but also again the ecosystem. But another part of that that you briefly touched on is the concept around clinical research staff and how we increase the pool of available employees for our community and our ecosystem here as a key component of that site centricity focus that I know Merck is so dedicated to could you provide some more details on some of the training programs that Merck has created or might be maybe involved with?

Jennifer Sheller 7:54

Sure. Absolutely. And I always go back to the letter that you issued a call for action, you know, to sponsors and CROs on the detriment of of not building a bench and just tapping into site staff as a, you know, primary source of talent. So,, A few years ago, we've built a very robust entry level program that just continues to grow in the U. S. We have it globally. We have internship programs globally, but we've really enhanced our U. S. program specifically. And we also have a pathway, you know, for college students to come in and come in and be trained entry level and taken, you know, entry level job clinical trial coordinator. It's now turned into sort of this rotational program. It's It's very attractive, and we give lots of candidates and that continues to blossom so that we are building our bench and not just relying on site staff as a recruitment method. We also are committed to the 1 10 program. So we have an office in the Philadelphia area, and that's really a commitment to bring non traditional candidates into our world into our profession. So non degreed African Americans in particular to bring them into you know, careers in pharma. In this case, it's I mean, there's multiple companies involved in one time, but in our case in pharma. So we have in our data management group, we have a group. I think we have about 45 now recruited building our bench with different talents and training up and upscaling and we continue to build. I think the goal is to get to 100 over the next several months or so. And then from there we build. You know, skills into CRA roles, associate CRA roles and and onward. And we thought, while we have such a robust program internally, sites are struggling, how can we help our sites? So we built a partnership with ACRP, the Association of Clinical Research Professionals. They've got incredible tools and training. We don't need to reinvent the wheel. So how can we leverage the ACRP tools to help build site staff? Not specific for our trials, but again, just contributing to that ecosystem. So we had a program that was launched targeting community college students and high school students in U. S. communities. And the idea was to raise awareness of Clinical research, you know, as a profession, jobs and clinical research, but also identifying these schools that are around our clinical trial sites so that they could be a feeder once they complete an ACRP program, they have a nice entry level program. These students could then be future research assistants at sites nearby. So we've had, I think, about 45 students graduate from this program. I know several have gotten jobs at nearby sites. And again, it's not for our trials in particular, but it's just a way where we're trying to grow the ecosystem. In addition, we use the CRC competency program that ACRP has, and we are offering that to our sites that are serving underrepresented racial and ethnic group communities. So we offer t raining for their staff to build their staff, whether it's new staff or staff to be developed. And this is really exploded. We have, you know, over 100. I think that have completed the program thus far, and we're now going into Latin America. And we're, you know, looking at getting translations and seeing how we can continue to build. And help train site staff. So we're kind of hitting it in multiple ways. We also are a sponsor of the National Medical Fellowships. Diversity and inclusion research program, and that program is aimed to build clinicians as as new investigators. So hitting it at all different facets. And again, it's it's really looking at it from an ecosystem standpoint. And if all of us could sort of contribute in these ways, we think we can make a significant difference. It's amazing when you introduce students to the field of clinical research, students who like science and medicine, maybe not on the path to be, you know, a doctor or or nurse, but want to do something different. And there's just so many opportunities that you know, that are very attractive to to students. So it's, it's been a great experience to see the reactions and also to see some of these students get jobs too.

Jimmy Bechtel 12:12

That's really cool. Jennifer. And again, the multi. Spoked approach to solving this problem, I think is really, really important because there isn't necessarily one answer to how we solve this monster of a problem around site staff. And it's clear that site input is so important into the work that you guys do, because both the diversity one that you talked about previously, as well as this site staff shortage challenge, What Is based on direct input from the sites, and so it goes to echo the points that we've made previously around your recipiency of that Eagle award. So how maybe does Merck ensure that it remains closely aligned with the needs and the perspectives, then of sites? And what steps do you take to prioritize that focus and improvements that have resulted from those collaborations then?

Jennifer Sheller 13:01

Yeah, and I first want to just, you know, share our operating model. So we invest a lot in our what I would call front line. Our CRAS are all dedicated to the Merck program. We have, Merck employees, but we also work with our CROs to have fully dedicated staff just to our program. So we invest a lot in training and upscaling our CRAs, but we also ensure that relationship and collaboration with sites is a key competency for this team. So that's a very robust way for us to get feedback on site needs and you know, help to shape our strategy. But I also just want to give a couple examples too, because this is really ingrained across our culture and leadership team at Merck. So, one of our leaders was at a conference a few years ago and was presenting inspection readiness and what people on sites need to do to be inspection ready and a coordinator raised her hand and she said, Well, that's great. It's great. You guys all come in right before you know the FDA comes in. But can you tell us how we're doing throughout a trial instead of just, you know, at the time of an inspection? So with that feedback, my boss came back into the organization and said, we need to build a tool for sites so they have transparency on how they're doing in trials. And with that was the genesis of what's called the site health check report, which is basically a report that was built with sites. So we pulled in sites to build it for sites and it gives the KPIs of trial performance compared to, you know, within a trial compared to their peers in the country or globally. So it's, it's really, one, I think, great example of listening to our sites and and and acting and we continue to do that. We have several offerings that we have for site support that are enterprise wide. And our mantra really is making sure that this is a la carte because every site has different needs. And, we're not here to force different things upon sites. So, the enterprise offerings that we've built has really been based on what we hear from our frontline and also in our site partnerships and site engagements. I think I shared with you last time. I'm often out visiting sites and many across my leadership team very senior levels are doing the same. So we continue to get that really customer feedback, but we've offered things such as the resource augmentation using a vendor if sites need it. And many sites have taken advantage of that and ebbs and flows of workload. We've recently offered an E binder solution. If you know, there's a lot of sites still in paper. There's great efficiencies that can be with an E binder. So we offer that again a la carte. It's optional. It's whatever, works for the site. We've also, implemented what I mentioned the Lyft transportation and ClinCard to try to reduce some of the administrative tasks for sites. We've simplified the use of SIP and taken the work back, shifting the work back to the sponsor and keeping it much more flexible. And there's more that will be happening in that space as well. All based on site feedback. We're also working on modernizing our technology and we've built in user experience as a priority pillar for modernizing our technology for clinical trials. And we actually have a dedicated team within our IT unit that just does UX design, and we've leveraged them and used them with our sites to build some of our tools, and we have a partner network of sites, and it's well known across our ecosystem that we tap into these sites sort of as representative surrogates for other sites around the globe when we have new ideas or tools, you know, we've recently had our supply chain coming forward with a few initiatives, and we wanted to see, is this something that would be helpful? What do our sites think? So we pull in round tables and that happens frequently and. Thank you for having me. You know, I would also say we're also working across our vendor partners, you know, to make sure that that same culture is embedded and that we continue to keep sites as a priority as as really a customer for our work and and serving them so that they can spend their time, you know, with patients and not frustrated on on administrative tasks and tools that are not intuitive.

Jimmy Bechtel 17:12

It's great, Jennifer. It's so interesting to see the approach that Merck takes because what I think is unique is that it goes back really to a cultural shift. Merck has prioritized at the senior leadership level, the relationship with the sites and allowed you and the rest of your teams to implement processes And plans based on site feedback that will actually affect the way that you work with them. So again, really just goes to speak to the fact that you're well deserved for that, for that Eagle award. I do want to shift gears a little bit and talk more specifically about technology and modernizing that technology for development is really a focus for everyone in the industry. So share with us how that modernization of technology benefits sites and trials overall and what we can do in the direction that we're heading there. And how does Merck specifically then plan to continue to grow its enterprise of site offerings and in the form of technology?

Jennifer Sheller 18:14

Yeah, and so I would say with the technology modernization, it sounds like a very blanket statement. We're really trying to shift. We're shifting towards a more platform approach so that we have as many tools and systems on one platform. It's not 100%, maybe 80, 20 so that we're more efficient in data collection and data review. So the idea would be to, you know, avoid Redundancy in data collection. So it's collected in one aspect. We don't need to redo it in an EDC or something of that nature. So in those areas we'll see efficiencies and queries in the volume of data collection. We're working on things like local lab normal ranges and making sure that we're supporting the entry of those ranges and then it has to just be done, you know, once and sites can just use a drop down and systems that, are more intuitive that convert units just really taking off some of those tactical steps that that don't have a lot of value. You know what I mentioned before with the user experience design. I think if you look at our smartphones are extremely intuitive for many different generations and populations, and we need to take the same types of approach and building tools as. As you know, Apple or or other companies, and that's what we're doing with our UX design team. So while we're partnering with a new partner in modernizing our technology there is an EDC system, for example, that's out there and has a lot of site users, but we want to make sure it's. That's a great superior user experience for our sites. And that's not up to us to tell the EDC vendor how to do that. That's really, really need to hear that from our sites. So we pulled together coordinators across the globe who wanted to participate to test the system and tell us what's intuitive. If you fill out this, is it intuitive where to go next? Or,. What do you want to see? What would help you in your workload management, within that platform? So the idea is really to optimize the user experience minimize the frustrations, you know, other things you hear of all the different logins that site staff have to manage each trial has several different logins and vendor solutions. So we're working on things like single sign on which I can't wait for and really just trying to ease that burden and make the experience more platform and streamlined versus, feeling chopped in sort of all different directions. So we'll continue to get feedback. As I mentioned through our front line through our country operations. We have our annual site surveys that we take very seriously and follow through and read every single comment and and look at the trends and support systems that sites are seeking. One example is while we have resource augmentation, that's for, more of the coordinator level role. There's a lot of pharmacy staff issues across the globe. So now we're exploring how can we use resource augmentation for maybe some of the pharmacy activities, and we're also looking at things like piloting API connections for eBinders so that there's direct document flow, and these are all things that sites have asked for, and it's actually built into our formal goals and objectives for the year and then we'll continue to be out there, continue to be talking to sites and and understanding their needs and making sure we're not making decisions from an ivory tower.

Jimmy Bechtel 21:33

That's great. It's an excellent approach and I applaud Merck for it because not everyone takes it, unfortunately, but the emphasis again from the top down that Merck has on that site focused site and patient focused mentality is really, really valuable and appreciated. I'd like to wrap up our conversation here, Jennifer, with one final question. As trials continue to become more complex, it's obvious that Merck is working to simplify them in their own way as much as possible. So can you maybe share what Merck is working on to simplify through the trial process specifically and how that might affect site operations and trial efficiency overall?

Jennifer Sheller 22:15

Yeah, we have mentioned just a few few points here. One is we have a vast initiative on protocol simplification and A lean design approach. So it's starting from what is needed versus I think in the industry, you see a lot of copy paste of protocols, inclusion, exclusion criteria. So we're shifting to a more lean design approach and and focusing on the end in mind and and critical data. And I think from a site perspective, that should feel lighter, right? In many ways. And you know, less heavy on on data collection. The other area we're focused on is query management. We have a dedicated team exploring, how we can improve and reduce our queries. So that we can make that a more smooth and streamlined and focus on what matters type of approach. The eBinder I had already mentioned that will really simplify document management. And in many ways, it will also facilitate remote monitoring, which I know many sites are eager to do. It's always a balance of, of the traditional on site activities and remote, but this is a great tool. And even in the U. S., I see a lot of sites still in paper, so there's still a great need out there, and we continue to simplify the technology for our CRAs, which indirectly impacts and influences our sites. So we have a lot of investment in how CRAs have to document things and make it really simple. So they can do it real time. So, really, they can focus on answering site questions and being there for sites and not getting caught up in too much of an administrative burden. So, yeah, we have many others. These are just a few that I'll mention, but really looking forward to some of the impact of some of these newer projects as we kick off in the new year.

Jimmy Bechtel 23:57

Excellent, Jennifer. Well, I think that's a really wonderful place for us to end our conversation. Thank you. A for doing all of these things on behalf of the sites and working towards greater site sustainability and be then listening to the site so that you can do these things. Because oftentimes we hear a lot of organizations that do. Listen and are very well intended, but then don't take action and don't make change as a result of that. So it's really inspiring to hear that Merck is not only listening, but also taking action. So again, thank you for being here with us today. Thank you for the work that you do. And a big thank you to Merck for continuously supporting the clinical research site community.

Jennifer Sheller 24:39

It's a pleasure and thanks. Thanks for this opportunity. And again, thank you to all of our sites for your collaboration for all that you do for patients. We tremendously value our relationship with you and work hard to meet your needs and understand your needs. We also recognize every site has different needs, so we're not perfect and we don't know all of the needs. So don't hesitate to ask. So I think that that's the next step is my message, and let's keep the dialogue open. We really value relationships, and we know that's really important. And you know, please leverage your dedicated CRA too who's really there to be your eyes and ears and support, and we'll continue to improve Jimmy and continue on this journey, and I look forward to sharing more things with you next year as we evolve.

Jimmy Bechtel 25:24

That sounds great, Jennifer. Thanks again. For those that are listening, make sure that you register for upcoming summits being held throughout the year by visiting our summit page on our website, mySCRS. org. While you're on our website, be sure to also check out the other SCRS publications and resources built for the site community we appreciate your participation in today's program and look forward to having you join us for more great content coming out soon. Thanks for listening.