A New Era in Clinical Trial Budgeting

A powerful new partnership is transforming clinical trial budgeting. Join Medidata’s Tina Mincher and NIHR's Laura Bousfield as they dive into the evolution of the UK’s Interactive Costing Tool (iCT) and its integration into Medidata’s Grant Manager platform—unlocking new levels of standardization, transparency, and efficiency. With growing international interest, they discuss global collaborations like the Global Costing Task Force and how this initiative is setting the stage for data-driven, cross-border harmonization in clinical research operations.

Transcript

Jimmy Bechtel: 0:02

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I am Jimmy Bechtel, the Chief Site Success Officer with SCRS, and I'm joined today by Tina Mincher and Laura Bousfield, Tina's with Medidata and Laura's with NIHR here to share with us a little bit about a new collaboration, a new partnership that they have, and a program that founds what this partnership really means. Really excited to have both of you here with us today to talk about this really interesting new endeavor between your two organizations and what the future of this program might look like. But before we get into that, Tina, I'd love to start with you with an introduction please.

Tina Mincher: 0:47

Thank you Jimmy, for inviting us to this podcast. We are very excited to be here. I'm Tina Mincher and my role is director in Client Strategy in the Clinical Trial Financial Management at Medidata. My focus in the role is on driving innovation and engagement, not just with our customers, but across industry.

Jimmy Bechtel: 1:10

Wonderful. Thank you Tina and Laura. Please, if you wouldn't mind, we'd love to hear a little bit more about you.

Laura Bousfield: 1:15

Hi. Well again, thanks for inviting me onto this Jimmy. My name's Laura Bousfield. I work for the National Institute of Health and Care Research based in England. And my role in this organization is to help speed up and spread out research on behalf of the public. Specifically, this includes managing the single UK costing tool which is required for all commercial research taking place in the nationally funded health system so that we can be efficient and effective at costing and contracting research.

Jimmy Bechtel: 1:48

Excellent. It sounds very interesting and I know everyone's excited to learn a little bit more about that. Tina, why don't you start us off. Can you set the stage and walk us through how this partnership between Medidata and the NIHR first came about and really why it's important for the future of clinical trial budgeting and what that means for all of us?

Tina Mincher: 2:07

Yeah, absolutely. So it's quite a unique and meaningful story actually. The partnership grew out of a friendship and a shared passion for improving clinical trials for patients. Our collaboration began well over a decade ago, I think pushing 15 years now, if I'm not mistaken. And that was when Laura and I first met to discuss the UK costing template, which at that point was a mere Excel sheet. And how this affected sponsors and CROs using benchmarking solutions. As a vendor of benchmarking products, we need to ensure that users have access to accurate and reliable data. And that's where Laura and I began working together to explore how we can incorporate the UK costing data into these benchmarking products to ease the challenges for the customers. Over the years, we kind of work together identifying pain points and investigating possible solutions and then finally we're able to bring the first phase of the integration to life, which we are thrilled about. It's obviously taken a lot of time. But we are very proud that Medidata was the first Life Sciences company to integrate the UK mandated health costing data into its financial products. I think this kind of collaboration is incredibly important for the future of clinical trial budgeting. With more countries developing their own national costing frameworks, the global landscape is becoming increasingly fragmented. Partnerships like ours can really help create a more harmonized and data-driven approach that benefits everyone, sponsors, sites, and obviously most importantly patients.

Jimmy Bechtel: 3:50

It does sound really interesting Tina, and it does seem to be the wave of the future. We know Australia is doing other similar endeavors when we talk about the national one-stop shop and what that means for them. This sort of unification and standardization around how we execute clinical trials and the various aspects of it. This is a timely conversation. Laura, the interactive costing tool that we are referencing here and Tina's alluding to has become really the cornerstone as we know of budgeting in the UK. Can you talk a little bit about how that was developed and what role your rather large constituency played in driving its adoption?

Laura Bousfield: 4:29

Sure. Tina has described wonderfully there how we came together. And it was actually in that role in the network where I had responsibility for the Excel version, which at the time was a best practice tool. This emerged from a n independent report. It was a recommendation to help ensure that the UK and the NHS were globally competitive and we were being transparent and clear around how the costing of commercial trials were being done. To even conceive that we could bring this together across that system. And do that across the Four Nations in the UK was already a huge ask in terms of best practice, but the NIHR has been able to work as a system partner with many other national bodies to actually drive this into policy. What this means is there's a requirement for NHS organizations to utilize this tool when costing commercial research, which has really strengthened that position of shifting the tool from a best practice that really did bring people together. There was lots of use of this tool before that allowed us to take the next step and really driving those efficiencies forward by, getting this in use at a study level. Doing this costing once on behalf of the system using a transparent tool. And really the key for that, facilitating that across the big system, has been to enable the expertise in all those delivery sites to come together. And the tool really is the mechanism for doing that. The transparency that it provides is really the key to building that trust. And I think that's back to what Tina was mentioning earlier around how do we make sure you've got up-to-date information. It's clear how that price is being built, how those numbers are being generated. This is based on activity related to the protocol. We want to be consistent and efficient in how we build that up, and that's the way that we will then build the trust in everybody working together using this product, and that unlocks the efficiencies. We are not doing this in multiple different organizations for a single study. It's happening once, and as Tina mentioned, this is all about bringing that access to the research to the patient sooner. We don't want to be spending time negotiating pounds and pence or in the global world or the currencies. We want to be making that as standardized and streamlined as possible so that we can get on with delivering those trials.

Jimmy Bechtel: 7:02

It is a worthy endeavor and I think one that probably lends itself really well to the way that you all are structured in Europe especially, and certain parts of the world. I'm really interested to learn more and keep an eye on how this continues to develop and continues to grow. It's really interesting to standardize costing at the clinical trial level. Tina, now that the integration of the ICT codes into Medidata's Grant Manager has been achieved, which we know is a major step and a really important part of being allowed to do this, what are the next steps to continue to build on the momentum here and make this tool or tools like it even more valuable for those that are participating in clinical trials?

Tina Mincher: 7:40

Good question, Jimmy. Successfully integrating the ICT codes into Medidata's grant manager is a major milestone. But there's still so much more to do. Right now we are building on that momentum by working to incorporate the French costing template as the next national data set in the product. We're really excited about the potential that this brings to our global users as it adds an another layer of precision and consistency to budget building, as you said Jimmy before Australia also have their costing template too. It's in parallel with our continuing kind of global collaboration with the NIHR, we need to ensure the UK data remains current and aligned with evolving needs. We're also exploring new ways to deepen the partnership and expand its impact. Whether that's through broader data coverage and analysis, enhanced functionality, or further international collaborations.

Jimmy Bechtel: 8:42

That's excellent, Tina. It is that concept of how we bring this to a broader audience and meet the needs from a global perspective for the various different countries and what their specific needs are. It's really awesome to hear the next steps are kind of global expansion into France and like you said the unique needs of various countries like Australia. And then Tina, what other, I guess continuing that trend collaborations are in the work. The Global Task Force initiative is one that comes to mind and what have been some of the major milestones along the way and what's on the horizon for these groups.

Tina Mincher: 9:14

So we are incredibly excited about the ongoing work of the Global Costing Task force. Our recent milestone was the publication in applied clinical trials. And the title of that publication, if anyone wants to read it, is Exploring The Perspectives of Fair Market Value and Clinical Trial Budgeting. And this piece brought together insights from across the industry to help educate stakeholders on the diverse challenges and the many different interpretations of fair market value. It was a true team effort. I think there was about 14 of us on there. Mammoth work went into it. We are thrilled that it's finally being released. Looking ahead the group are currently kind of identifying next key areas of focus. There's definitely no shortage of important topics from demystifying overhead calculations to shining a light on hidden costs. That I know is something that you know a lot about Jimmy, because there's an SCRS upcoming workshop to talk about hidden costs. There's so many areas to tackle, but ultimately the global costing task force is about building awareness, and aligning stakeholders and promoting transparency across the entire clinical trial ecosystem. Because I think the more informed each player is, the more efficient the process becomes.

Jimmy Bechtel: 10:37

I couldn't agree more, Tina. It's a really great sentiment, the unification and some universal acceptances of standardization, whatever you want to call it. There's a lot of opportunity there in clinical trials to really help drive some of the efficiency forward that we all know our industry lacks so much of. There's such a great a deal of opportunity there. Really cool to hear that this is just one example of what sounds like many different opportunities here. Laura, I'd like to end then with you here with our final question around increasing international interest in the UK's model. How can initiatives like that costing task force help amplify some of the progress on a global scale. In other words, how can we look to initiatives like this to make a difference in maybe some other countries or at a global level?

Laura Bousfield: 11:23

Yeah, great question. For me, that group is absolutely the next level. We've been talking about UK wide or countrywide, and this is bringing together insight from around the world. Could we scale this up? This is the question that's the next level. This is all about learning from each other. You mentioned Australia previously, who are building on lots of models from around the world and being really successful at that. For a public funded healthcare system, like the one in the UK that's trying to integrate research as part of care. The more understanding we have, the more that we can step away from price negotiation and we can focus on things like resource needs and building the capacity to deliver the research in that care setting, which is what is keeping research accessible for patients because research is care, but we also need to recognize that we have to be transparent in how we are defining the resource required to do that within that system. The amplification of this countrywide model really helps to normalize this approach. When the UK started out Scotland that had the first countrywide model for commercial research, and when we were beginning to expand this across the UK. There were lots of places around the world looking at that template, but we were taking it into that place of defining its use at a study level. The more locations that begin to look to streamline and harmonize costing as we've talked about throughout this conversation, it's helping to shift that mindset and behaviors so that we can actually embed this type of approach. And even for non-publicly funded research settings, it does make sense for everyone to get involved. When we're delivering the study, you are only gonna get the payments for the activities that you do. We really do it doesn't matter how skillful your negotiation might be with that pricing, it almost becomes irrelevant if we can't open the site quickly enough to recruit or we don't recruit the numbers that we need to. I think it's that shift in mindset and focus about what we're trying to achieve here.

Jimmy Bechtel: 13:28

I couldn't agree more. I think there's a lot of really great opportunity internationally rather for endeavors like this and looking to find how we can build efficiencies in the clinical trial process and standardizing some certain aspects of it are definitely routes. There it comes with its own unique set of challenges as you can probably imagine, which is probably why you mentioned it in the more private sector. Much like what we have in the United States here. We definitely hear some challenges to potential standardization and things like that around what we're doing here. But again, I think that there's opportunity if we just take a minute, step back, put it nicely, change mindsets and really focus on what's important when we tend to talk about executing clinical trials and starting from that foundation. It's a great place for us to end our conversation here. Laura, Tina, thank you both so much for being here and sharing a little bit more about this. Something that I hope our listeners, were able to gain some knowledge on and maybe go forth and gather a little bit more information to do some research and really learn what this initiative and this program might do for the rest of the world and what it's doing in Europe. So Tina thank you for being here.

Tina Mincher: 14:32

Thank you for giving us the opportunity Jimmy to share our story with the incredible SCRS family. You do amazing things.

Jimmy Bechtel: 14:40

Thank you. And Laura, thank you as well for being part of the conversation today.

Laura Bousfield: 14:44

Yeah, echo that. Thank you for inviting me and let's see where this takes us.

Jimmy Bechtel: 14:49

Well, thanks again both of you. And for those that are listening, make sure to explore other site focused resources made available through SCRS on our website, my scrs.org, other publications, more SCRS talks, and of course the Site Solutions Summits and other publications made available throughout the year. Thanks again for listening and tuning in, and until next time.