Behind the Budget: Exploring Hidden Costs in Clinical Trials

Hidden costs remain a persistent challenge for clinical research sites. With over two decades of experience, SCRS Project Manager Mike Pierre discusses the evolution of hidden costs, the ongoing efforts by SCRS to address them, and the launch of a Hidden Costs workshop. 

Whether you're a site owner, budget negotiator, or industry sponsor, this episode provides valuable insights into the complexities of clinical trial budgeting and the impact of hidden costs. Learn how to equip your organization's budget and contract professionals with the knowledge to navigate and negotiate hidden costs effectively.

>>Join us for the Hidden Cost workshop at the Global Site Solutions Summit.
>>Download the SCRS Site Invoiceables Toolkit.

Did you know? SCRS was just ranked a Top Clinical Research Podcast by Feedspot! Thank you for tuning in!

Transcript

Jimmy Bechtel: 0:00

Greetings and thank you for being part of the Society for Clinical Research Sites on SCRS Talks. I'm your host, Jimmy Bechtel, Vice President of Site Engagement with the Society. Get ready to dive into pressing clinical research industry topics, celebrate noteworthy achievements, and create a deeper connection with the research community. This is the space to amplify voices and perspectives that shape the landscape of clinical research. today we have Mike Pierre, a project manager within SCRS who has a long and ingrained history around negotiating contracts and being an expert in the field of hidden costs. Mike, it's great to be able to talk with an SCRS colleague about this important topic. And I know you've been out in the industry spreading the good word around hidden costs for a long time and have recently restarted that work, which is why we're here talking about this today. So Mike, it'd be great for you to start with what are hidden costs. Can you help us define that term a little bit better?

Michael Pierre: 1:00

Sure. But first I'm not an expert as much as I am outspoken on this issue. So the hidden costs in trials are the things that the site is doing For a clinical trial that are not specifically covered in the budget and they are also things that a site would just assume they should be doing And not keeping track of how much time it takes them to do all these different items. It'd be things like the the time and labor for processing a protocol amendment or an irb renewal, things like that where there may be hours and hours of undocumented or unaccounted for labor with regard to a specific trial.

Jimmy Bechtel: 1:38

Thanks, Mike. It's, always been an interesting and hot topic within SCRS. It's something that we've had as part of our summits. Again, it's something that I know you've talked about and advocated on for several years now because hidden costs keep changing, right? As we go about our clinical trials in new ways, I know that Those come with their own new sets of hidden costs. So it's a mainstay within the work that we do. So as I had mentioned in part of the introduction, SCRS is with you at the helm re embarking on this path of hidden costs so can you talk a little bit about why SCRS is launching that program and talk about what that program is and maybe dive a little bit more into its history and focus?

Michael Pierre: 2:21

We used to do this. So SCRS years ago did this in person and then we, we had done it as a webinar series, but the webinar series I felt we missed that interpersonal touch that happens when you meet a group of people face to face rather than over the internet. And so I wanted to have this program relaunched in order to help educate budget and contract people, mostly budget people, but a lot of people at the sites do both, on how to analyze a protocol and compare it to the budget that you're offered, how to make your changes, how to justify the changes that you make. And I wanted to keep it short, sweet and small. You get in, you get out the same day. It's nine to four so that you don't have a coordinator out of the office for two days traveling. I wanted to keep the cost down to to bring in those kind of people at the sites. When we have our larger conferences, most of our attendees will be site owners, site managers, and it's not really cost effective to send your budget negotiator to a larger conference to maybe catch a breakout session, or maybe meet some people. So that's what I wanted to do. Bring it back so that budget people can spend a day, meet each other, meet sponsors and CROs that attend and get this information.

Jimmy Bechtel: 3:43

Well, it's great, Mike, because like you said, they oftentimes don't have a chance to glean and lean into the knowledge, take advantage of the knowledge that we do provide through our events, other than maybe the occasional webinar on the topic or a resource that we might put forward for them. But even then, We're not sure it does a great job of getting back to the people at the budget and contract level. So it's a great focus in diversifying some of the work that we do.

Michael Pierre: 4:12

And it's a great way for site contract negotiators to meet each other because they don't really have that opportunity to do that. So, the history of this program was that Christine Pierre and Ken Getz, 25 years ago, Did a one hour presentation at an ACRP conference on the hidden cost of conducting clinical trials at the site. And they got a lot of response. So after a presentation like that, you say, anybody who wants to know more or talk to us, give us your business card. And they just had packs of cards. And so Christine and Ken did this again, same response, and it started to become more popular, and I just started at RxTrials, which was the site network I was working for at the time that Christine owned, and she couldn't make a conference, and so she sent me down there to give the presentation. So I did that at a local meeting, and, Still, the enthusiasm was there from the sites. Again, as I mentioned, very popular, not because of the information, but also the attendees got to meet other sites and make friends and talk about their issues that they have when negotiating clinical trial budgets. So then Christine and I turned it into a one day. Then it went to a two day in person event we'd have four people to 25 people, and One of the most common positive evaluations we got was that people were so thankful that they got to meet other people that were also doing this, because otherwise, they don't know. Sites had tended to be in the past, which SCRS is really helping to remedy, to keep to themselves and not divulge any of their contract or budgeting techniques and things like that. So now that we're spreading this around through all of our conferences every year. It's been a big change in that perspective. And from that Christine said, well, let's have a meeting. That's how the 1st site solution summit was started in Santa Fe, New Mexico many years ago by just getting people together to talk about this topic. And it's just gone from there and SCRS has grown out of that. So that's another reason why I wanted to relaunch the program because I wanted to get back to that and go out there and meet people for the first time. People that didn't really know about us, but are interested in budgeting and contracting. So that's why I'm relaunching it and we're going to travel it around. We're looking at four times a year in person.

Jimmy Bechtel: 6:29

It's really cool, Mike, because that connection aspect is something that we often overlook beyond what we're able to accomplish with our, our summits that we regularly have. And it's making those connections for those people so that they have other individuals to lean on to Maybe bounce ideas off of to get engaged with the SCRS community in a new way. It gives them that initial touch point. And like you said, it was really the impetus for the birth of the site solution summit and SCRS as an organization. Kind of that whole concept of education, mentorship and connection that we bring to the site community. So that's great. Speaking to some of what we bring in those ideas, what is the value of this program not only for sites as you've touched on, but also for sponsors and CROs then?

Michael Pierre: 7:20

So the benefit to them, cause It started to dawn on me as I was giving these presentations for us to tell a site to evaluate a protocol and look how much time you're spending on different items and get a handle on that and my message to the sponsors and CROs, which I'll bring up many times during the presentation is, when you're looking at a site. You have to look at what they have available as far as resources and decide, can they really do the things they promised? So yes, we're going to put a vaccine trial at your site and you have two days to enroll. You want to ask the site, how many coordinators do you have? What have you put aside? What's your technology and your training look like? So that the site can really fulfill what it is they say they're going to do. That's the biggest value, I think, for the sponsors and CROs. Secondary to that would be also, of course, getting a real kind of look behind the curtain as to how sites think and what they say and what drives their decision making when they decide to either take a trial or how they're going to fulfill what the protocol has set out.

Jimmy Bechtel: 8:29

Well, it's really interesting, Mike, because we don't oftentimes think of what that brings to sponsors and CROs. And I could see how sponsors and CROs knowing that we're doing something like this could be like, Oh, they're, you know, they're getting together to price fix or collude. And that's really not at all what this is about, right? It's about helping the sites understand what Some of their actual costs are that would get overlooked if they're not included in that kind of per patient per visit budget. It's, it's those extraneous items that do cost them time, energy, and money. And Mike, can you talk a little bit about what you've seen, maybe just highlight a couple of things or trends that you've seen has really changed over the years, because like you said, you've been involved in this for over 20 years, and I'm sure so much has changed. Because hidden cost as a concept, as we mentioned, Really, it hasn't changed. There are continuous hidden costs. Some of them are probably mainstays. Some of them haven't changed over the years, but there are probably things that have or trends that have changed. So can you talk a little bit about what has changed and maybe what stayed the same over the, over the years that you've been doing this?

Michael Pierre: 9:40

Sure. Back when I first started to do it and I know Jimmy, you worked at a site too many years ago, their non refundable startup fee was something you had to ask for and justify.There were closeout fees and laboratory closeout fees a lot of sites are putting in their contracts for change of monitor and things like that. When I see a contract today, the budget section. The list of those kind of fees is very long and there didn't used to be any. So the sites are really getting on board with this and it takes time. You got to understand that when a sponsor gets a request for something they've never seen before They can't just say, yes, yeah, I'll do this because, you know, they're under internal audit and external audit, and they don't want to have, you know, 20 sites in a trial and one investigator pops out who's getting paid all these other things that all the rest aren't. So they have to be able to justify that and defend it. And it's problematic for them to do that. So it just takes a long time for sites to keep requesting things. And then it just falls under the fair market value and becomes universally acceptable as, okay, this is a fee. Everybody asks for this. It's reasonable. It's been defended through every research conference for the last 15, 20 years. So yes, we will start including that in the budgets. So that, I think that's The biggest trend I've seen is how many things are being included in the initial offer by the sponsor or the CRO that the site doesn't have to just build the whole thing from scratch. It's already in there. And then there's, and there's things I hadn't even considered. There's one sponsor that just says, here's a contingency fee of X amount of dollars. Speaking of the money, you mentioned it quickly, but I did do want to say that in the, these presentations, we do not tell anybody what to charge for anything. And all the examples that we put up are. Suppose you charge this. We don't get into price fixing or collusion or anything like that.

Jimmy Bechtel: 11:40

Yeah. Important point. And what I took away from your answer there, Mike, is I think it's an important understanding that the sites approach this with is that it's not a short game when you're trying to negotiate something new. It's a long game. And What I know that the message that SCRS will to say SCRS perpetuates, because I know you and I perpetuate it is that you don't just ask for it. Three times assume that, Oh, I'm never going to get this and then stop asking for it because it's that consistent asking from all of the different sites that really moves the needle. And that's the power that SCRS brings this industry is if you know, you continue to pound the drum on that fee or that issue or that cost consistently, even if you don't see any movement on it for a number of years, eventually, if all the sites start asking for it, that's when we start to see things because you gave really good examples of a case where that exact thing happened over the years. So that's that's a great message to bring forward.

Michael Pierre: 12:41

Yeah, and some other trends I've observed in contract and budget negotiation over the years have been two large items that we see on our landscape surveys each year, which are the withholding percentages and the payment schedules. And those continue to get more favorable for the sites, but I would argue they're more favorable for the sponsors and CROs as well. If you have a site that's being paid monthly with zero withholding percentage, that's going to be a very responsive site. Some sponsors today. Are offering both of those things, monthly payments and zero. The site doesn't even have to negotiate with them. It's just right in the contract. So it takes that entire portion out, cuts down on negotiation time, and then you've got a site that is being regularly reinforced through payment that the sponsor or CRO has an invested interest in them part performing well in the trial. So that's two trends I've picked up on, as I mentioned before, all the other new line items that I see all the time, but payment schedules, withholding percentages, they're really trending more favorable for the site participation.

Jimmy Bechtel: 13:48

Mike, talk a little bit about trends that you're seeing on the sponsor and CRO side as well. How are things going, with them and their I guess, realization around hidden costs?

Michael Pierre: 14:00

Well, what I'm seeing is their interest. So for anyone that doesn't know, we have a payment initiative going at SCRS and there's three work streams. One is participant payments. The other is withholding percentages and the other is payment schedules. And a good quarter to a third of the participants in those work streams are sponsors and CROs. They're interested in this. They want to know more. They kind of want to know what the rest of the industry is doing with regard to these topics, and they want to improve that relationship. And so they take great interest in that, and they participate completely in all three of those work streams as part of that initiative.

Jimmy Bechtel: 14:39

I mean, it's great, right? You have investment with time and energy into those important work streams, again, continuing to move the needle withholds and monthly payments, but also tackle that taxation of patient reimbursement and patient stipends is, we know, a huge issue, particularly here in the United States. So that's that's awesome. Looking forward then, Mike, give a sneak peek of some of what this new refreshed version of hidden cost series and this program is going to cover.

Michael Pierre: 15:06

Yep, we talk about all kinds of budgetary items, ones that everyone has seen before and other considerations for new areas of research. We still do the classics of payment schedules and upfront payments, withholding percentages, invoicing, pricing out long term document storage. We price out each of the areas, you know, time permitting for all startup and closeout portions of a trial, as well as kind of the inter subject portion where the site's doing things that aren't related to either startup or closeout, but monitoring visits and technology training and e source, e consent, e reg, all the costs associated with that. We really look at it to determine, you know, What the I won't say a burden, but that you know the cost the resource expenditure for those items. So what? While the sites are certainly on board, as you can tell from our survey results, they are fully embracing all the technology and they're very happy to move their site into the future. Anything that helps bring new drugs to market and help people they're fully on board. They just want to make sure that with each new technology, the promises you is typically. This will relieve some kind of burden and they're finding it may have relieved a prior burden, but now there's a new one and everyone needs to find a way to convert that expense into some kind of terminology to help them express it and then have it reimbursed.

Jimmy Bechtel: 16:37

Yeah, it's a mix of the old and the new right, and the mainstays and the things that we're seeing here in modern clinical trials, which is, which is awesome. So Mike, as we begin to wrap up here, I'm, I'm really excited about the, the new hidden costs. I think a lot of sites are going to be excited to o. I know you had a session that you had run with Parexel and our partners there and some of Their partner sites and are again, as you mentioned, getting ready to do this in, in Florida. But can you talk a little bit more about how sites can learn about the hidden cost series?

Michael Pierre: 17:06

Yes It's going to be a couple of days before our global. Summit in September, which begins on the 27th. Keep an eye on LinkedIn and your email. We're going to host it on the 25th of September from 10 to 4, and that is prior to our global summit that's going to run that weekend.

Jimmy Bechtel: 17:25

Excellent. Thanks, Mike. And again, really excited to bring this up and revive this program and bring some of that really valuable information, connection opportunity, resources, tools, knowledge back to the research sites and, and modernize some of what we're doing in hidden costs. So thanks thanks for sharing and thanks for spearheading that project. I think it's a tremendously valuable asset to the site community.

Michael Pierre: 17:48

Yep, and one other thing prior to that, as a primer, check out the site Invoiceables Toolkit at our website, mysrs. org. As a primer for that, it's a very long and well researched tutorial on invoicing for hidden costs.

Jimmy Bechtel: 18:03

Great point, Mike, and another great tool for the sites. as we wrap up, don't forget to explore more site focused resources like the site invoicables toolkit on our website, myscrs. org and many others. You'll find a wealth of content and publications plus the opportunity to save your spot for upcoming webinars and SCRS summits held throughout the year. Thank you for tuning in and until next time.