In this part 1 video (see part 2 here), we discuss three tips to help study sponsors manage the rising costs of investigator fees in clinical trials. Part 2 of this video series will be released on Tuesday May 11, 2021. What else would you add to the list?
Contents of this episode:
02:01 Evaluate Protocol Procedures & Visits
04:58 Evaluate ROI from Previously Used Sites
09:22 Be Prepared to Walk Away
Video Transcript (verbatim):
Hi everyone. Welcome to another episode of ClinBiz where we love connecting with you on the business aspects of clinical trials. So, in today’s episode, we’re going to be talking about the subject of managing the rising cost of investigator fees or investigator grants within clinical trials. So, this is going to be a two-part video series So, stay tuned for part one.
Well, welcome back. Thank you So, much for joining us. So, in today’s part one of this two-part video series, we’re going to be talking about managing the rising cost of investigator fees within clinical trials. So, why this is important is I let you know right at the beginning just in case you want to know if you want to watch the entire video. This topic is very important because investigator fees as many of you know really takes care of a large portion of a global clinical study budget for study sponsors specifically and that’s the glance or the perspective we’ll take on
in this video is really from the study sponsor perspective. It’s a very, very important cost category that gets a lot of attention from sponsors, from study sponsors especially the financial people, right. So, it’s very important to manage these costs. And because of the last few years there’s been a consistent rise in these costs, we’ve gotten a lot of questions from our community, from the ClinBiz community and others in the industry about what are some tips, some things to better manage these rising costs investigator fees.
So, in today’s video we’re going to be sharing the part one of this two-part video series because we want to make sure it’s digestible for you and we’re going to be sharing three tips or three things you should really be looking at to manage better these rising costs if you’re a study sponsor and really if you’re within the industry it’s very important for you to even know about these three tips as well. So, let’s get on to tip number one. So, the number one thing and this doesn’t go in any type of order of priority or importance and it is an exhaustive topic to talk about but we’ll cover a couple of things here. So, number one tip I would mention is to evaluate your protocol required procedures and visits very, very important early on even if you can do this at the protocol development protocol design and protocol development stage it’s very important that you evaluate your protocol procedures and visits to really see what are some must-haves and the nice to haves, right. I’m a big advocate of the protocol design maybe not the protocol design per se but definitely within the development stage to have some type of a financial minded person within those types of meetings, within those discussions. Really looking at the protocol before it becomes final to really look at and ask questions around what those procedures or visits are going to mean to your organization you as a study sponsor let’s say in terms of the financial impact. It’s very important to have those discussions and one of the reasons why it’s important for this tip for you to look at your protocol requirements visits early on is because each of those procedures you’re adding to your protocol we obviously know if you’re within clinical operations world at all that each of those procedures and visits have an impact to the patient, the site
just operationally, right? But sometimes teams don’t think about the financial impact that one procedure added in there or one study visit is going to have financially to the organization and then eventually obviously to the entire ecosystem right of clinical trials and eventually it will impact drug pricing as well.
So, it’s very important to know if you’re adding a protocol procedure or visit that you understand all the trickle-down effects financially that also, in in addition to operationally but all the impacts it will have financially. So, for example you can add one procedure in there and what you’re really doing is not just adding the cost to that procedure you’re adding the costs associated with that procedure in terms of time and effort from let’s say a coordinator or a PI or data entry person you’re adding a couple of invoicables in there potentially as well. So, you need to think about those protocol procedures early on at the protocol development stage. If you can, have someone financially minded that really understands the impact of each of those procedures financially to your organization within those meetings early on and that really will help you to better manage at least for your organization the financial impact and the rising cost of investigator fees, okay?
Number two. Number two, I would say to evaluate your ROI from previously used sites. So, we’ve mentioned this point in another video we made about strategic site selection and this is absolutely critical that you do as a study sponsor. Many study sponsors actually don’t do this and it’s really something you’re missing out on, right? You need to be evaluating how your research sites that you usually use or you’ve previously used for a trial how they’ve done in terms of what they’ve delivered versus what they have promised you they would deliver and I’m not just talking about number of patients, right? Because we know that this is not a perfect world obviously and things happen and sometimes people are not able to recruit what they intentionally–they intended to recruit initially, right? And that’s fine but we’re really talking about how to deliver all the other pieces in terms of communication with your teams, in terms of you know answering to queries clean data that they provided right, turnaround times for CTA or budget negotiations. So, you need to be having this rear viewer mirror perspective when you’re evaluating new sites for your study. Look all you know most study sponsors you have this data, it’s a matter of capturing it somewhere initially and then making it systematic to look at that data before you begin a new trial, before you make your site selection and look at how have sites done. What’s the ROI, right? What is the return in your investment of those sites and how they’ve delivered in terms of the entire experience and the entire relationship they’ve had with you from previous trials? And then really you need to be using the sites that are doing well, the sites that are great to work with, you have a great relationship with, sites that deliver what they’re promising, obviously sites that do well in terms of recruitment of the correct patients and bringing those patients to having access to that trial and you need to stop using the wrong ones, right?
So, sometimes sponsors have an issue with going back to sites that are not performing well or sites that don’t do well or ask for a lot of things but really don’t deliver on their promises, right? And also, I just want to make a note before you know because we have a lot of sites that watch our videos. This all of these tips go actually both ways, right? You can actually apply many of these tips to your negotiations with study sponsors and who you’re selecting as well. So, this is not only from the sponsor side although this video is geared more to the sponsors, right? So, that would be the second point, evaluate the ROI from your previously used sites and use that information to inform you on your future decisions of which sites to go to. This is very important because you’re going to be identifying sites that have performed well and you’re really going to be using right your dollars as a sponsor to fund for the sites that do well that actually respond well within your trial and enroll correctly you know enroll well and do correctly all that’s required within your protocol and you’re really stopping the draining of that money from going to sites who are not doing well ad sites who do not perform well. That’s really a big draining of that money that’s going you know towards bad sites many times you know called bad sites because there’s bad sponsors too, right? And you’re not utilizing the funds correctly to go to actually well-performing sites, sites that actually return you know have a good return on that investment of time and effort from you as a sponsor and for the entire relationship. So, focus on the good sides and apply your funds to them and stop using those bad sites. That’s a clear way for you to cut costs and investigator fees is to really take a look retrospectively how those sites have done and only invest in sites that are actually performing well. That’s a good way to cut down on those costs for sure.
Okay, now on to point number three. This is our last point for this video. Again, this is going to be a two-part video series we’re releasing the next video next week on Tuesday. So, make sure you stay tuned, you subscribe to our newsletter so, you are notified. So, here you have number three. Now this one may not be very popular. I will give you a warning beforehand but it is very important. And this is actually very important for both study sponsors and research sites but today we’ll just cover from the study sponsor side. And that is be prepared to walk away very important for study sponsors and you know all stakeholders in negotiations to be very clear at which point you’re willing to walk away from that negotiation. Over the last few years study sponsors have been more and more willing to cover all the different costs from research sites. I mean, I think there’s still you know a lot of situations where those are not covered and need to be covered if they’re appropriate costs we’ve always advocated for that for sure. But sometimes that has actually brought things to the other side of the spectrum for some sponsors and sometimes sponsors are really not willing to walk away from a research site.
I have to say it’s very important and what ends up happening is sometimes you use some bad sites over and over and over again and you end up losing your money like we spoke about in some of the previous points of this video. And sometimes that can also put you in murky waters as a study sponsor because you’re more and more willing to cover costs that perhaps are really kind of in a gray area or perhaps not appropriate at all. And if you’re doing that, if you end up doing that, you’re really putting yourself in murky waters.
So, you need to be prepared to walk away at a certain point and you need to communicate that very clearly to your organization from up top. You need to be able to communicate that. What is that point of walk away? What are things we’re willing to cover, first things that we’re not willing to cover and really be– be very clear and empower your negotiators and empower your clinical team to make those decisions when needed. Very important because I know sometimes as an industry you know there’s a big pressure to move things along fast and there’s a big pressure to recruit and there’s a big pressure to have a site on board and have it initiated that sometimes you know there’s just that pressure and study sponsors are you know much more willing to work with that site that’s negotiating rather than have another one or look for another one. But this is very important very early on for you to be able to first of all, identify those sites that are performing well and use them you know all those things that we mentioned but also, be prepared to walk away when a request is not appropriate and that needs to be very, very ingrained in your organization and that’s really going to help you save lots of money from increasing costs from those costs. Sometimes you may approve for one study and you think it’s just a one-off. It’s not going to be. It’s probably going to be for many other studies to come and it may even spread to different sites requesting that same thing and you’re going to be put into a situation as a sponsor that you don’t want to be in.
So, it’s very, very important that you be prepared to walk away and have that very clear early on and empower the people in your organization when they need to make that tough decision to make that decision. Again, this can also be used for research sites. So, we’ll make maybe a video in that another day. So, there you have it a couple of those tips for you. We will have the second part next week. So, you want to tune in for all those great tips as well and I just want to remind you that we are actually having the ClinBiz Virtual event in October this year. October 19th through the 21st. It will actually cover many of these types of topics around contracts, budgets, payments, clinical outsourcing and clinical business operations. It’s going to be an amazing event full of the latest trends, the latest topics, latest best practices. We’ll be doing also an industry survey before then and we’ll actually be showcasing live the results from that survey so that you have the latest and greatest around these types of conversations.
All right. Thank you so much for watching. I hope you subscribe to our newsletter if you haven’t so you’re always informed of the latest information we have around these topics and until next time take care. Bye-bye.