Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 2 – Study Start-up

Transcript: 

Sandy Smith: 

Well, fantastic! Again, I want to welcome everyone for joining us for the second in our three-part series on thriving in clinical research, overcoming common challenges as a site, and for today’s webinar, we are focusing on study startup. My name is Sandy Smith. I’m a senior vice president with WCG, focusing on clinical solutions and strategic partnering. And joining me today is an expert in the study startup field, Jody Ingebritsen Howe. Jody is our director for site budgets and contracts at WCG, and I would say is our guru. We know that this work is both an art and a science, and Jody’s got some great tips to share with you today. So let’s take a look at today’s agenda. As we are doing in this series, we are focusing or sharing some of the data from our 2023 WCG site survey, and we’ll show you some of those market trends, but really the the focus of our webinar today is on study startup processes, issues, and bottlenecks, as well as solutions. Again, I want to thank those of you that, in the registration phase, submitted questions. Jody has received and reviewed those. However, we will receive questions during the session today. We will be reviewing them during the course of Jody’s comments and then asking them at the end. For that, please use the Q and A box that you see on the bottom of your screen.  

We are going to start with a couple polling question so we know who’s joining us today. The first is, what type of organization do you represent? Are you coming from a site which might be an academic medical center, an integrated healthcare delivery system, a community hospital, a site network, a physician practice, an independent site, or are you one of our industry partners, either sponsor CRO? And if none of those fit, just mark other. So we’ll give you a moment to respond to that and bring up the results. Okay, a lot of site representation, but we thank our industry sponsors that have also joined us today. I referenced earlier the 2023 Site Challenges Survey Report, which is available at no cost on the WCG website. You see the web address listed here. Go to www.wcgclinical.com. We polled over 500 clinical research sites in the first quarter of 2023, and this has been an ongoing effort from year to year, but our overall goal is to continue to have our finger on the pulse of where those pain points are at sites, and to gain the insights regarding the challenges that they’re facing. In addition, we also have some recommendations for sites, sponsors, and CROs on how to reduce the site burden and improve overall efficiency. So again, our goal here is just bridging all the stakeholders so that we can keep the clinical trials process moving forward and getting very much needed clinical trials to patients. So please download that report. It is available on demand, and we will be updating it in 2024.  

So, some of the information from that report, first of all, who responded of those 500 sites that were contacted? You can see there’s a broad array of individuals. 31% of the respondents are research administration staff. Many of those in leadership roles, but we also had a very good representation of clinical research coordinators as well as clinical research nurses. But in addition, you’ll see we even had investigators respond. When we look at the where they’re from, just shy of 40% came from Academic Medical Center, and we had a nice representation from physician practices. And over half of the respondents to this survey were operating with more than 26 trials at any given time, and you can see a large number of them, you know, even doing more than 150.  

All right, we’ll take a look now at the overall survey results and why this topic was chosen for the webinar series. We have asked the same parameters from year to year. In 2023, because we heard so much about the complexity of clinical trials, we added it to the survey, and that did tie with study startup, our focal area for today. So, study startup continues to be among the top issues that are challenging sites, and we do know that with the great resignation, the ongoing turnover that’s occurred, all aspects of clinical research have been impacted, whether you are directly interacting with research participants or you have a very significant role in the study startup process, having to deal with many of these administrative functions. All of them do require specialized skills.  

When we look at the survey results and break them down between academic medical centers and non-academic medical centers, you can see the ranking still remains quite high, still in that top three, or in the case of the academic medical centers, it’s in the top four. So, is this having an impact on sites? Well, according to the responses, it is with 52% of the sites saying it is impacting the site’s ability to agree to participate in new studies, and we are hearing all kinds of things like, in some cases, polls on opening new studies; in other cases, very stringent reviews on determining what types of studies will be opened, and clearly this this remains an issue, and it has been an issue for the past few years. But knowing that these challenges exist and looking at solutions and alternate ways of addressing them is really the importance of having a light shone on these issues.  

And so looking at the percentage of staff turnover, you can see here we’ve broken it down by quartiles. AMCs slightly different in terms of the percentage of staff turnover from non-AMCs, but disruptive nonetheless. Looking at the non-AMCs, it looks like things may be settling down a little bit more there. They obviously had about a third of their team that fell into that less than 5% category, and what we are hearing is many positions are being filled. There still seems to be some degree of turnover that’s occurring, even with newly hired staff. But we’re also hearing that many sites are experiencing their positions are fully full and they’re moving forward. So it’s much better than I think it was back in 2021 and early into 2022. 

And then because complexity was mentioned as well, we just wanted to identify one area that seems to be a recurring theme related to complexity. There’s many many factors that fall into that definition of wire cites saying complexity of trials is an issue, but one we hear a lot is the impact of amendments. So the data that you’re looking at here comes from Tufts, and the question asked is what percent of phase three research trials have had substantive amendments, and as we compare 2015, where about two thirds of the trials had substantive amendments in 2022, that number was much higher, coming in at 82 percent of the phase three research trials had an average of three and a half substantial amendments per protocol, and defining a substantial amendment means one that requires, obviously, the sponsor’s engagement needs to be submitted for ethical review, requires a change to the informed consent, and then does require reconsenting. But this is not just an issue with phase three trials, as we’re also reporting out here for phase one trials, that increased by 15 percent. So again, just one aspect of what’s leading to the complexity. And as we talk about the topic of the day, contracts, budgets, negotiations of those, the amendment process certainly does weigh in significantly.  

So we’re going to have a few more polling questions, and then we’ll turn it over to Jody. What is your current actual average time frame for completing clinical trial budget negotiations? Is it less than 15 days? 15 to 30 31? to 45 46? to 60 61, to 75 76, to 90, or over 90, and the results. Okay, we have some really efficient sites. A few that are getting it done in under 15 days. Looks like we still have a significant number over 21% that it’s taking them over 90 days, and and again different levels of success scattered throughout. Thank you for that information. The next one: What is your current actual average time frame for completing the clinical trial contract negotiations? The last was budgets. Now we’re asking for contracts. Again, the same parameters from under 15 days all the way up to over 90 days. And Jody’s going to have some great data to share with you on what we are seeing. All right, looking at the results. Again, fair number of folks that are getting it done very very quickly, but still now over 25 or 25 percent over 90 days. All right, thank you so much. With that, I would like to turn it over to Jody. Welcome, Jody. 

Jody Ingebritsen-Howe: 

Thanks, Sandy. First, let me apologize for my voice. I am in the thick of virus season with a toddler, so I I apologize for the nasally sound of my voice, and I’m hoping I don’t have any coughing fits. But if I go on mute randomly, that’s why. Okay, so basically, I want to talk about what the study startup process entails. It could mean a slew of things, right? So, I’ll do a broad overview of what activities are included when I say startup. What activities might cause challenges, and what we can do to help streamline and/or hopefully solve these challenges.  

So, in order to define what study startup means, I’m just going to walk through on this flowchart what a process might look like for a site, and here’s what I’ll add as a disclaimer. This is a broad, zoomed-out look, and therefore very oversimplified of what the startup process looks like. So we’re looking at heavy lifting for most, if not all of these bubbles, I’m summarizing with a broad title or phrase to capture what it looks like, just so it fits within the bubble, and I’m not bombarding you with all the text in the world. But each step, it potentially and likely does involve multiple departments, multiple stakeholders, multiple specialists, and in a couple cases, entities that have conflicting interests, right? So negotiations. So, as you all know from being involved in clinical research, this is not an entry-level industry. It’s niche. It’s high pressure. It’s high stakes, and it is complicated with a capital C. So please, nobody should take from me or from this webinar that this is just a simple seven-step process that we can get one bubble out of the way every single day and have it all done in a week. Ideally, awesome, but this is a beast of a process. So that’s my disclaimer, just so that no one walks away from this saying, “Jody said it’s an easy little process.” No, it’s it’s a beast. So, I’ll walk through what what each of the bubbles actually means out here. So first, there is a feasibility process. There’s a selection process. There are approvals. So IRB approval might happen here. Internal site approvals. Things like financial approval and review, legal review, compliance reviews, regulatory reviews, maybe oversight or research committee reviews. There’s a lot of things that happen in order to essentially get your foot in the door with a sponsor and with a study opportunity. That’s all built within this first bubble. Again, you can kind of you can kind of hear what I’m saying. It there’s a lot of things that might be happening here. Maybe for your site it’s pretty simple, but for other institutions it’s really not. So this bubble though is what’s going to get you in the door with a study opportunity where we can actually like get some progress going with all the various entities involved in the study startup process.  

At this point, we move to the next bubble. The sponsor or their vendor, a CRO, will send over the protocol that might have already been received, and then draft documents for your review for the site’s review for editing and for negotiations. So this would be the informed consent form, which I call the ICF here, the budget, and then the clinical trial agreement. Which again, for the sake of brevity in this webinar, I’m going to call the contract. That is all when when your staff gets your hands on the documents that you can actually start analyzing, reviewing to get again to get ultimately the study opened. So next bubble, this one’s a big one. We will have we being the site, and I’m mostly talking to the sites here because I know that’s the biggest chunk of our attendees here, but I know there are also sponsors and CROs in the room too. So just know when I’m talking, I’m talking primarily to the site here. But we, the site, should have an internal, you know, billing compliance specialist. Take a look at the protocol. You’re going to look at all the activities occurring under the protocol. You’re going to analyze whether the sponsor is paying for each activity or whether the patient’s insurance is going to be paying for each activity. It’s called the coverage analysis, and it’s essentially the compliance map for your billing and your budgeting folks. It’s going to break down which items are required by the protocol and which ones are standard of care. It’s going to break down the billing rules and regulations related to each of those activities. It’s going to break down what insurance would cover, if relevant for each activity, and then it directs your billing and budgeting folks down the road for what they’ll need to do. So, in the case of budgeters, it will direct them on what items the sponsor should be paying for, as part of the study negotiation, and in the case of your billers, it will direct them on what to actually do with the costs when each activity occurs. At the same time, while the coverage analysis is is being developed. You can take the contract that was received from the sponsor, the CRO, and you can start having that reviewed. In ideal situations, you can send that right into negotiations. So the contract is, you know, off to the races while there are still some pieces on the coverage analysis and budget still being developed. But at least you can have the contract moving. Back to the CA track, though. After the CA, the coverage analysis, is developed, then you can start working on the internal budget. So this is basically taking the roadmap that the coverage analysis creates. Now it looks at the costs that the sponsors should be paying for. They’re not going to be compensated by anyone’s insurance, and it figures out what costs, what you know, what compensation you actually need from the sponsors in order to perform the study without taking a financial hit. So there are other costs that are considered here too. It’s not just protocol require you know study specifics, but any administrative costs that you your site will actually incur to run the study, things like your administrative startup, your archiving fees, fees that you might incur to tap into other departments, like you know, your your radiology setup fees, your pharmacy setup fees, that kind of thing. In order to tap into those departments’ staff and resources, you might have to incur a fee from those departments. So the internal budget establishes all of that. It gives you a very detailed you know document that shows all of your actual costs, your staff rates. You know, the the actual cost the study is going to cost the the financial hit that the the site will incur to run the study. It’s tailored to you. It uses your verbiage, all of that good stuff. So this is your document as the site. This is not something that you’ll share. This is something that you will use to then move on to the next bubble, establish your sorry review and negotiate the actual budget template, which is received from the sponsor. So this budget template is tailored to each sponsor. It is, you know, formatted at their preferences. It meets their needs. It might be less detailed than your internal budget. It will be less specific than your internal budget. It will use their preferred verbiage, not necessarily your site’s verbiage. It shows the amount in that initial offer that the sponsor intends to pay for those protocol required activities, and it tells you upfront which items the sponsor is prepared to pay for. So you can do an internal comparison between that template and your internal budget, to figure out where you might not be in alignment with a sponsor, and then you actually take the sponsor’s budget template and you edit it. So you’ll you’ll you know increase their initial offers to match the costs that you need. You will build in things like your administrative fees that the sponsor isn’t necessarily putting all of that into their template because it’s very different for each site. So you you build all of that in to the sponsor’s template, and then that is what you’re negotiating with them.  

So moving, I guess, kind of at the end of this bubble before we move to the next bubble, you’re hopefully negotiating the contract already. You can start negotiating the sponsor’s budget. You go back and forth with the sponsor and the CRO. You come to an agreement. You get it finalized. You get it signed. Very oversimplified, but hopefully easy process. You just get it everything finalized and signed, and then at this stage, you or the you know regulatory folks at the site will take a review, take the the template ICF, the informed consent form received from the sponsor, the CRO. You will ensure it matches any mutual understandings that you’ve now gained with the sponsor from your budget and contract negotiations. So things like stipend amounts, things like subject injury compensation language, that kind of thing. You’ll make sure that the ICF is in alignment with your final negotiated documents, your budget, your contract, and then that can be finalized, sent on for final IRB approval. Boom! Now we’re ready to open the study. SIV will happen, then a study can open. So, I’m assuming a majority of you look at this and you say, “Great, but you know where you know our IRB approval actually happens at step seven, not at step one. Our IRB approval happens at step you know two and a half, maybe. Where does my job of reviewing and sending initial documents to the sponsor happen? Again, just just as a reminder here, this is an oversimplification. I will have some recommendations based on this flowchart on future slides, but there are steps for I would say if we had 10 different sites, there would be 10 different flowcharts. It just looks a little bit different for everyone. So I didn’t want to throw a bunch of detail into this and then make people think that they have to redo their entire flow. This is just you know an example of what it looks like for a good chunk of sites, and the point of this entire flowchart essentially is to show you that there are so many opportunities for things to get stuck, for things to slow down, or just in general for things to get a little messy. So, you know, even super super organized sites might have issues in startup, but we can do some things to try to help. So, next slide.  

What do we do to get ahead of process issues? Process being related to that flowchart. Number one, let’s define on a site by site basis. Let’s each define what the process looks like for your institution, and I can’t say this enough, but get detailed with it. Get detailed with what your flowchart looks like for your site. So use the specifics that aren’t on my flowchart. Essentially, put in where the initial IRB approval happens. Put in which stakeholders, which departments, which individuals, all of that sort of thing need to be involved in each step. Put in anyone’s name, you know, who needs to approve certain steps, like the coverage analysis, or you know, the internal budget, the final contract. Put in their names. Who do you elevate things to that get stuck during negotiations? Put in all of those details, lay it all out, so that you can see at a glance what your own institution’s flowchart, your startup process looks like. My guess is this is just a little bit more detailed. A lot of us have a flowchart. We have an understanding of what the process is, but when you actually go to the effort of documenting it, laying it all out, and getting detailed with it, a lot of you may actually see right up front, clear as day, where there are gaps and where you are having startup issues because of those gaps. Some of you might see that there are, you know, conflicting instructions. Well, we do X, Y, Z if it’s this type of study, but we don’t really know who does things when it’s this type of study. Lay it all out there. Get hypothetical with it. In these situations, it goes to this person. In any situations, it goes to this person. Be just be as specific as you possibly can with it. I think there would be a good a good result in in everyone just figuring out where there are issues, where there are obvious gaps, maybe where there are less obvious gaps, maybe the gaps are in staffing. Maybe the gaps are in expertise. Maybe the the gaps are in you know when we have to elevate to this person, we get things back within two days because they don’t have as many responsibilities on their plate. But when we elevate to this person, they have 17 other departments that are asking them constantly for questions, and we get we get responses from them in three weeks. That sort of thing might just be highlighted if you lay all of your process flowchart stuff out with detail. You might be able to see some of those less obvious flow issues.  

Number two, develop the coverage analysis before you actually develop the internal budget. This is on the flowchart I showed, but our recommendation here does come from a little bit of experience. It does sound like some sites do these in tandem, but we find that the process goes a little bit faster, maybe not faster, smoother, less hurdles and less hiccups if you just focus on one task at a time. So develop the coverage analysis, get that done, and then use that copy paste into a separate document and use that to build the internal budget. Then you will ideally also, if there are questions that need to be answered in the coverage analysis process, that will help you, so you’re not creating also errors in the internal budget. You’re you’re getting everything sorted away with the covers analysis before you develop the internal budget. Also, hopefully, creates less misalignment between documents if they’re both being developed in tandem. You can create some confusion by just having to sync everything up in the end instead of just doing one at a time.  

Number three, develop a playbook for your negotiators. So this is establishing your contract requirements, your budget requirements. Determine what are your actual requirements versus your preferences. The nice to have items, but you’re not going to die in the hill for these items, or you’re not going to elongate negotiations just to get some of these items established. Lay all that out so that you’re essentially empowering your negotiators to move as fast as possible towards finalization, since that’s the goal: Fast finalization as of an Inspire Site Challenges survey here. We need to speed up this process by giving everybody all the tools they need upfront before they enter, you know, the ring of negotiations. Give them all the information that they will hopefully need. Get stakeholders involved in the actual development of the playbook. That way, you’re avoiding things having to be elevated to them for each separate negotiation. So, I get stuck on contract language, you know, three separate provisions instead of me having to elevate those three provisions to legal and waiting for feedback on each of those. Get legal to provide hypothetical alternative language options, or if actually pushed, we can accept this upfront within the playbook, so that your negotiators know they can accept that after a couple of rounds, and they don’t have to elevate for each negotiation, that kind of thing does cause massive delays. You know, some for some institutions, it’s a pretty finely tuned machine, and it it’s only you know maybe a couple minutes to get that finalization approval. For others, it’s significantly longer. So that’s just one thing that you could do to help make things go a little faster.  

Last but not least, number four: finalize the contract and the budget before you finalize the ICF. At the very least, finalize the the topics that are being addressed in the ICF within the contract and the budget before you worry about finalizing the ICF. That way, you know if if I’m still hashing out subject injury language in the contract, and someone is thinks that they finalized it in the ICF. After my contract is done, they have to reopen negotiations on the ICF. We’re just creating kind of a mess. Just wait on the ICF until the contract is done. You shouldn’t have to renegotiate everything within an ICF finalization process. You should just be able to say like, “Hey, this is what we came to an agreement on in the contract. Let’s move. Let’s finalize the ICF. Should make things a little bit easier.  

Okay, next slide. So our survey identified that initiation timelines were a challenge, so I just wanted to show a little camaraderie in the industry here. Our experience does match this survey result. We have seen a steady increase in negotiation timelines since 2020. Now, worthy of mention here is that 2020 brought some pretty incredibly fast-tracked studies due to COVID. But even so, our teams do recognize that this line is going the wrong direction, so we’re refocusing our efforts on fast finalization, updating our strategies to do so. Those all started, you know, in quarter four. So our hope, our goal is that this line starts to come down, and I know that’s many of your goals as well. So before we get to solutions on it, though, I just wanted to talk briefly on some of our thoughts on why these negotiation timelines are going in the wrong direction here. Next slide. 

And this is nothing new, but we’re still having to fight for every single dollar of startup, not necessarily, but that’s wrong. Like that’s that’s part of the negotiation, right? We have to. We have to argue for our costs, but some, you know, a lot of times we’re having to argue in multiple forms. We have to provide evidence of administrative costs, and then we have to provide rationale, and then we have to provide additional rationale, and then we have to provide cost breakdowns and all this sort of things. And we’ve actually seen, and I’ll say here another disclaimer: not all sponsors, not all CROs. So this is not across the board. But we’ve seen some sponsors where their initial startup offers are going in the opposite direction of what, to me, is common sense. You know, over the years, there’s you know inflation is happening, so costs are going to go up, cost of living is going up. So you know there are startup costs tied that should be in theory also increasing. But we were seeing some sponsors where that startup offer is lower and lower, or they’re really stuck on hey you agreed to this two years ago. Yep. Yeah. I mean costs change every year, so it feels as if we’re having we’re having to rationalize startup costs more, and we’re still, as you can see, the discrepancy here between the startup amount proposed in blue and the final amount negotiated. It’s pretty large, so we’re having to argue for a pretty big gap here, and that is delaying negotiations. And again, that’s nothing new. This is something that we expect to have to argue for costs, right? But hopefully, you know what we would see is that every year that initial startup amount proposed would be kind of increasing as well because they acknowledge that these costs are increasing, and we’re not necessarily seeing that. And the same thing is happening for per patient. You can go to the next slide, Sandy.  

I won’t dive into the details too much. The per patient costs-it’s there’s also still a battle. But again, some of it’s reasonable, right? It’s just that we we are having to justify in various forms and through multiple rounds, especially when CROs are involved. That we’re, you know, we’re justifying a couple times to the CROs, and then it feels like we’re justifying again to the sponsor sometimes. So that is something that that seems to be happening more, or seemed to happen more in 2023 for contracts. And we’ll go to the next slide here.  

We are also seeing some trends on the contract side, and the contracts are kind of my where I come from, the land that I come from before overseeing the contracts and the budgets at WCG. So I have some more examples, more details on some of the contract stuff, But we, yeah, we’ve got we’re seeing trends all over the place. One of the trends that we’re seeing, specifically in 2023, and I don’t know that I understand why, is that we are seeing a failure to track changes. So, if any of you have done contract negotiations, you know what track changes is. It’s my little image here is the button. It’s in Microsoft Word. It’s where you turn track changes on. What it allows for is that you see the historical back and forth for each round of negotiations. You see that on you know November 6, Jody changed this language to this, and then here’s my little rationale blurb. And then on November 7, the sponsor responded, and this is what they did. What we’re seeing, what we seem to be seeing, and I don’t want to again, it’s not every sponsor, it’s not every CRO. I’m assuming some some sites are doing this too, so it’s not just one-sided. It’s just that I only see it from one side. Is that people are turning track changes off when it benefits them. So we are seeing. I put in edits in my first round, initial red lines. I send everything to the sponsor. I get edits back, and sometimes I am seeing that the original language has been reverted, but it’s not being tracked and it’s not being called out to us. So it just looks as if this was already always language that was accepted. What that does, it poisons the wealth immediately. I don’t trust this negotiator anymore because they’re making changes that, in a cynical world, that’s sneaky. That’s you’re you’re making changes that you’re not calling out to me. It is absolutely going to slow down negotiations because now instead of just relying on the one version in front of me, with all my back and forth history, I have to open up the last version I sent, and I have to do a line by line comparison to see did something get snuck in here that was not called out. That is going to take if I would normally take, let’s say, 45 minutes to review a 30-page document to see what was changed. It’s going to take me over two hours, two and a half, three hours, just to do that line-by-line comparison. So right there, we’re slowing down negotiations by this practice, and it is harming reputations. So the most egregious thing that I’ve seen in the last couple months is a document that was accepted, sent for signatures, changes made in that 11th hour that were not called out. They were not. There was nothing via email. There was nothing via track changes. Nobody said anything that changed substantively what the contract was saying. Luckily, it was caught before signatures happened. But why did that ever? Why did that happen? So now that it happened to be a CRO, what happens is that behind the scenes here, my team, my contracts team knows that anytime you see something from this CRO, we are doing a line by line comparison of every single word, even if you seem to have a good flow with this person, it happened once. I my hope is that it was a bad actor, and we don’t have to worry about it forever and ever. But it it did harm that that CRO’s reputation in our team’s mind, and now we have to do that sort of a review each time. Unfortunately, so hopefully not a trend that we continue to see, but it is happening on occasion. Next slide.  

There are other situations too, and I will just provide context for my picture here. Eli is on my team. Eli is not a bad actor that I’m just calling out here. He had a situation of a negotiation where a zero or sponsor was asking to justify every single edit, everything, even stuff that was typos, comma in the wrong place, a double space that didn’t belong, using the wrong defined term, having to justify every single change made, and instead of calling out the person that did this in his negotiation, he just recreated it with his own name. So just putting it out there, he is not the bad actor here. We’re not, but this is something that has happened. Now, just to set the stage, our team we encourage providing meaningful rationale for changes whenever we’re making them, whenever you’re rejecting edits, we encourage providing rationale, and it’s not that I’m saying I don’t want to provide rationale at all. It’s just when it’s every single thing, things that go without saying, right? It feels as if we’re not being met with common knowledge and you know common judgment of like, yeah, I made that change because it’s the wrong defined term. I made that change because this is, you know, this is not applicable to this study. Can we can we just move on? Like, do we have to provide? So providing justification for every single edit is also going to slow down negotiations. Okay, next slide.  

And then just a couple other bad habits, and I won’t go into these. These are again just a little bit more contract examples. But anyone, I think sites do this too. My team has been trained not to because it’s a pet peeve of mine personally. But I know there’s all across the industry it happens. Deleting language in chunks instead of, you know, basically just to replace your preferred language, but it says largely the same thing. But you’re just deleting all of the sponsor’s template language in this paragraph to put in what you want. Not the best habit. It’s just going to elongate negotiation back and forth. Just learn to weave in the language that you want. Use as much of the template language as you possibly can, and just weave in the stuff that you need. Then provide rationale on a couple of those things that you actually need, but don’t just replace whole paragraphs with your preferred language. That doesn’t serve a great purpose. And providing rationale that simply says we prefer this, that’s not meaningful. We can infer that if it’s if you’re editing a language, we can infer that you prefer it. But why do you prefer it? Why is it required? You can save yourself multiple rounds of negotiations, at least one, if if there’s actually an operational reason why you can’t agree to language, or why you insist on language. Explain that up front instead of just deleting it and saying we prefer it. Now explain why. That’s going to get you a lot farther, and it’s going to save you a couple rounds of back and forth in in a good situation, ideally. Okay, next slide.  

So here’s my solutions. My that I think you’ll probably recognize, are things that I’ve said so far already. But I’m just going to re-summarize as my solutions. Number one, identify your process hurdles. Get ahead of issues to the extent you can by figuring out where you have process gaps, where you have you know staffing needs where you have folks that are wearing too many hats, and therefore they they you know can’t review things within a couple days. That take that’s why it takes them three weeks. Maybe you’ll find out the the obvious things like yeah we need more staff. Maybe there will be more subtle process issues that you can identify by detailing out your flowchart, and and it will help you and your research team as a unit figure out solutions. Instead of you know our our webinar here is is broad, right? It’s it’s to capture as many as many ideas as many sites as possible. But if you do this within the walls of your own institution, within the folks of your own team, I think it will be enlightening for a lot of folks on just like, oh yeah, this is clearly causing an issue. Let’s talk about it. Let’s figure it out. Um, and don’t next next one here. Don’t be part of the problem when it comes to negotiation delays. So, what do I mean by that? I mean for budget specifically. I mean you you need to have a fully developed internal budget and budget playbooks. So you’re sending your budget negotiators into the ring with well-informed guidance and documentation to guide them. I want them to know what they can and cannot agree to upfront in terms of dollar amounts. I want them to get to the finish line without constantly asking for approval on everything. You know, like if we can give them a range of dollar amounts that you can accept, if you can give them, this is the ideal, this is the second, you know, preferred, and this is the absolutely, if absolutely required. If you can equip your negotiators with all of that information and knowledge, it’s it’s just going to get you to the finish line that much faster. I also mean by this that your negotiators should be prepared upfront to rationalize the costs that they’re requesting. So, give them administrative fee schedules they can provide to sponsors. Give them information on how internal costs are developed, so they can actually speak to what each cost entails-that’s a big one. That you know, sponsors and CROs asking, like, what’s built into this? You know, what’s embedded within this cost? Give them that knowledge so they don’t have to turn around and ask seven other people. Tell them during your budget playbook development what’s baked into these costs, so they can just be the front-line negotiator and they don’t have to involve other departments in every single negotiation process. Basically, giving negotiators as much of the information upfront as they may need, and and it might be hypothetical. It might just be more intense training processes for some of the negotiators, but just giving them all of the information or as much of the information as you possibly can, so they can be fast in their negotiations. This is a big one. Have your negotiators ask questions if they don’t know what a cost in a sponsor budget is referring to it might just be a semantic difference, and you can save everybody time and confusion by just having negotiators ask a question up front. We’ve seen this a couple times where just things are you know the sponsor is calling something different in the site, and and I think that there’s probably sometimes an ego issue, right? Like people don’t apply the issue, however you want to say. People don’t want to say like I don’t know what that means, but have them be forthright with the other side during negotiations. What what does this mean? Just so that we’re on the same page, or I know if we’re completely not talking about the same thing, that will get you a lot farther than you think. Just being real with sponsors and CROs, and sponsors and CROs. Being reals, being real with the sites. I’m just like, hey, what are we talking about here? You might find that it helps save a round, and and a round doesn’t sound like much, but a round can easily be 30 days, right? So save as many rounds as you possibly can. Lastly, be prepared to actually negotiate, and here’s where the ego steps in again. Right, know that you are not going to get everything that you want from every single negotiation, but if you equip your negotiators, back to number one here. If you equip your negotiators with what is and is not reasonable to accept, then you will still, even if you don’t win every single dollar that you want, you will still come out with a win because you’ll get a final budget way faster, hopefully, and ultimately you will be able to enroll folks in this study faster, and that’s the goal, right? Like we want more studies opening on a yearly basis, so that we aren’t part of the problem of why there are you know drug development delays and patients that just can’t enroll in studies that really need to. So, be prepared to negotiate and and do whatever we can to avoid negotiation back and forth, back and forth, back and forth for you know three months. I saw in the survey results there’s a lot of there’s a lot of sites that it’s regularly happening over 90 days. The negotiations are taking over 90 days. We all want to get that number down. So whatever you can do to equip your negotiators with more information upfront, so they can help bring this number down themselves, that is going to be key to this. And now for contracts, that was all tailored a little bit to budgets. It’s it’s essentially the same the same recommendation, you know. I think each site. It’s a good idea to have a playbook for your negotiators. It doesn’t have to be a huge thing. It just has to be. You know, here are the things that we absolutely require. Here are the things that we absolutely cannot accept. Here are the reasons for it. There’s legal reasons. There’s you know regulatory compliance whatever the case may be our state law doesn’t let us agree to that so equip your your negotiators with that actual level of detail so they don’t have to elevate we have seen so many projects where you know we don’t we aren’t you know given the authority to accept deviations from the preferred language, and so we have to elevate every single thing within every single contract. Sometimes there’s really good reasons for why certain language needs to be elevated. There need to be, you know, exceptions and approvals in those sort of exceptions each time. But for the vast majority of topics, you know, just equip your negotiators with here’s our preferred ideal language. Here’s some backups, and if absolutely pushed, we can accept this language, so that they elevate a little bit less to your legal teams. Equip your negotiators with, you know, they should know why they’re making edits. They should know. They should be able to provide meaningful rationale. That might mean a little bit more training for some of the negotiators, but you know, let them know if they’re changing language because of compliance issues, because of statutory issues, whatever. Let them know that and encourage them to provide that rationale upfront in the red line to hopefully not have to go back and forth a couple times just to get to that same answer. They should be trained. Ideally, again, this is my pet peeve. So I, but I hope you guys will see the value in it too. Is they should be trained to actually weave in the language that they need instead of just chunk delete, chunk insert, copy paste, and that doesn’t actually help the negotiation go any faster. Nine times out of 10, it just elongates things, and and this is ultimately the sponsor’s template that they sponsor for the CROs template. So we want to use as much of that template language as we can, and just modify the language that we actually need instead of, you know, replacing entire swaths of pages worth of language. They should be trained in how to use track changes. Everyone should be on the same page about that. They should use it. And again, ego pride here. They should ask questions. If they don’t know what language means, they shouldn’t be shy about asking. It’s it’s impossible to know everything. There are provisions that are being added, you know, every year that are kind of new. Just have them ask if they don’t know what language means, and hopefully, we’re also, you know, they’re also trained before they enter the negotiations, so they’re not asking things like, “Hey, what’s PHI? But things you know that like, “Hey, I haven’t seen this language before. Can you explain why it’s being required? Or, “Hey, look, you know, we usually agree to about one year for this. Why are we now being asked to do this for 10 years? That sort of thing. Just just have them ask questions up front rather than just rejecting the language, that level of asking questions is going to go really far when it comes to finalization timelines. And lastly, again, be prepared to negotiate. They’re not going to get every single word that they want, but hopefully, we know exactly which phrases, which words, which provisions we actually have some requirements built into and what what provisions. This is just language that you know our teams really like to see and understand that you’re not going to win every single argument. And hopefully, all of that together means that we are streamlining the entire startup process a little bit, especially. and I think Sandy, you can go to the next slide.  

But especially with the the topics that are being discussed in the other site challenges webinars, there are staffing and retention issues baked into all of this too. There, you know, expertise is really hard to have a staff become experts if they’re turning over every four months. You know, so some of this stuff, this is not entry-level stuff, but having as much of it as you can documented in you know the flowchart that that your site will hopefully have and your budget. Yeah, sorry, your budget playbook and your contract playbook. Hopefully, by increasing your documentation for that sort of thing, it’s that that much easier to get people established and running within what your site needs to help start up. So, give my voice a break here, and I’ll let you host the Q and A session here, Sandy. 

Sandy Smith: 

Yeah, Jody. Thank you. Thank you. Such great comments and things that oftentimes aren’t really identified as some of the trends that you’ve noted. So we do have a couple questions that we’d like to ask in our remaining time. The first is, you know, you laid out that really nice process map, and with that, I’m sure you’re thinking there’s some timeframes that you like to associate with each step because at the end, looking at the entire study startup procedure is something that most sites are tracking, and we hear a lot of sites say we are trying to turn things around in a day or two, or we’re asked to do it in a day or two, but then when we get it back to the CRO or sponsor, there’s no response for long periods of time. So, how do you address the slow responses from CROs or sponsors during that negotiation process? 

Jody Ingebritsen-Howe: 

Yeah, I’ll say that is certainly an issue. It’s an you know site response times. I’m sure are an issue too. One of the things that I think will get at this is you know back to my original slides is providing as much rationale upfront as possible. I know that if I if a contract were to land in my inbox, two contracts land in my inbox at the exact same time, exact same deadlines, the one where someone is providing really meaningful feedback in word bubbles that says like, “Hey, this is actually like we cannot accept this because of this regulatory requirement. This language is okay. This language isn’t. We we actually we’re stuck on this one if they provide me with more versus the contract that just it’s sent back to me and it says please justify please justify please justify I’m gonna address the first one first the you know the one with a meaningful feedback where I feel like we’re getting some traction right the one that someone is just asking for justification times 300 within a contract, I know that one’s going to take my full mental capacity for hours. So I’m going to sit on that one until I’m ready for it. And honestly, I think you know I would love if I didn’t have you know if I could just address everything based on the order it comes in. But there are we’re all humans doing this work, right? So there are times that that is a factor, and we’re. I’m trying to make things easier on the sponsor and the CRO when they when they read my edits too. I want it to be easier for them so that they address my stuff faster. So that’s one way. That’s just one, you know, I guess process change that we can do to hopefully speed up response times. Other things, though, I think you know checking in every week. I think that’s not a bad idea, just to let everyone know, hey, this hasn’t fallen off my radar. I’m still expecting a response on this. If you’re not getting a response in a meeting full time, right, like three weeks, you haven’t heard anything. What I, you know, typically do is like, is there? I send an email and I say, is there someone else that should be handling this? Is there someone else that you want fielding my questions? Worst case scenario, I think there are study teams where the PI would, you know, prefer to hop in and say like, hey, something’s going on. No one’s responding to our negotiators here. So if it if getting timelines sped up is the goal for, I assume every single attendee here, it might just be flagging studies faster when you haven’t gotten a response within a couple weeks, and then figuring out in your flowchart what’s going to be our tactic here-is it going to be involving the PI? Is it going to be looping in other folks at the? You know, we’ve got an initial site selection email from the CRO, and there’s four names on that email. Let’s email everybody and see if it’ll stick with somebody. Same with the site. If the site’s the reason you know people aren’t responding in a timely manner, you know, figuring out is there someone else that we should work with. I think those are reasonable tactics, and and understand that we’re all busy, right? We’re but if there’s if there’s anything we can do to just increase communication, giving people a call and saying like, hey, just want to make sure this is still on your radar, and you haven’t just, you know, outsourced it to somebody else, and you didn’t tell us. I think that’s probably the first, the first option here that I just forgot about. But I would say do that first, and then you can start looping in anybody else that that might be able to help. 

Sandy Smith: 

The art of picking up the phone. Good advice. So, as we saw in the survey, we do have a number of our industry partners joining us today, sponsors and CROs. What are the things that you have identified that they could do to possibly help expedite the budgeting and contracting process? 

Jody Ingebritsen-Howe: 

Yeah, I think I think that’s a great question. One of the things is that it it does feel like there are a lot of approval or elevation points, especially when there’s a CRO involved. Things are that’s where we’re seeing more issues of having to justify every single edit is when it’s a CRO, and it’s before they can elevate to the sponsor. And so I wonder if you know the sponsors are not necessarily providing or equipping their own CRO negotiators with playbooks similar to what I’m talking about of like, this is a range of language that we would be willing to accept if pushed. So the frontline negotiator in that situation, a CRO, can actually agree to a couple things, and it can say, you know, accepted pending sponsor’s final approval. It doesn’t have to be a set in stone promise. You know, we’re not like initialing each edit, but giving the CROs or giving the frontline negotiators the actual authority to change language on on certain provisions, especially provisions that you can guess are going to get modified. Right, indemnification, subject injury. It’s going to get modified. It’s, I mean, until the templates are all we’re all working from the same template. There’s going to be issues with with templates. So that’s what I would say. More willingness across the board. This is for states too to to use master agreements is probably an answer here, and. and also a recognition that just because costs for language was acceptable two years ago, now I want to be able to use previously negotiated language and costs as a starting point to make negotiations go faster. But just because, I guess that’s my my key phrase is as a starting point. I don’t want to be held necessarily to language or costs that were agreed to two years ago or even one year ago because situations change. There is evolution of costs. There are evolution of you know legal requirements, and I would like for us to both understand that, and instead of being, it feels like forced to agree to prior language just because it was, you know, agreed to in the past. Establish that as great starting point language, but I still would like everyone to be willing to hear arguments that, like, hey, our requirements have changed here. Can we open up the negotiation on this topic, even though we agreed to it a year ago. That is, I guess that’s one of the messages that we would love for some of the industry sponsors out there to hear. 

Sandy Smith: 

Great points. Well, Jody, we are coming to the close of the hour. Again, I want to thank you for sharing your past experiences, which are vast in the negotiations process. Also, want to thank all of you for joining us today. And as we mentioned early on, this is a three-part series. But do join us. We do have a bit of a break now, coming back on December 5 for the third part in our site webinar series. This one dealing with site capacity, which was the number one concern expressed in our site survey. So, thank you for joining us today. The replay will be available on our website, and we appreciate your questions as well as your time. Be well.