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Study Activation Survey Results and What it Means for Sites

June 14, 2021

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About the Advarra In Conversations With…

The future of healthcare innovation hinges on research and clinical trials. Advarra sits down with leading experts to dig into pressing issues and explore cornerstone solutions. Join us as we discuss topics and trends impacting the healthcare of tomorrow and advancing clinical research to be safer, smarter, faster.

About this Episode:

In this episode, Jake Meyer and Candi Barlow review results from Advarra’s recent survey and discuss study activation success strategies for sites. Our experts share their thoughts on budget negotiation from how to make do with a tight budget to taking less conventional approaches.

Discussions with:

Jake Meyer
Former Business Operations Services Manager

Candi Barlow
Former Clinical Research Informatics Specialist

Episode Transcript:

Jake Meyer (00:03): Hello, this is Jake Meyer, and I am the former Senior Manager of the Business Operations Services here at Advarra. I’m happy to be joining the fourth episode of Advarra in Conversations With. So, with that, I’ll hand the mic over to Candi to introduce herself.


Candi Barlow (00:20): Good morning, my name is Candi Barlow and I am a former Clinical Research Informatics Nurse on the Bio-Optronics side now with Advarra.


Jake Meyer (00:29): So today Candi and I are going to discuss the results of Advarra’s recent Study Activation Survey. Specifically, aiming at the clinical trials site budgeting and billing complaints portions. From pain points like staffing and turnover, budgeting dilemmas, startup costs, negotiation timelines to Medicare coverage analysis, and more. So, hey let’s get going, first a few housekeeping items I have to run through.


What is this Study Activation Survey we will be referring to? So, Advarra developed a series of questions aimed around clinical trial activation tasks, at the research site or hospital level, job functions like IRB tasks, informed consent writing, obviously research budgeting and billing compliance, as well as other areas for touched on in this survey.


Candi, taking a bit of a step back, it may be helpful just to share why we’re the ones talking about these subjects, could you share a little bit more about your background.


Candi Barlow (01:36): Sure, so my background is 20 plus years in clinical research, I am a nurse by background and have worked at the site side pretty much all of my career. Recently moved over to the technology side to help advocate for sites and part of that includes this budget negotiations coverage analysis piece, it’s part of what I had set up throughout our system that was completely electronic and had no bill holes. And so, by being able to come on this side, I can help with the electronic piece to teach sites, how to do this because, as you’re going to see we’re going to talk about some of the difficulties that sites have and how, perhaps we can have some solutions.


Jake Meyer (02:18): And Candi is the brave one here for anyone listening in, as a nurse. My background is in finance, so definitely different ends of the spectrum here.


I’ve worked with sites around the country performing Medicare coverage analysis in clinical trials, as well as negotiating budgets for research sites and with that, I have roughly six years in this industry.


So hey great two more quick items and then we’ll dive into these results, and we can get going, but Candi I will toss these two questions to you. Okay, can you describe the difference between an Academic Medical Center versus a non-Academic Medical Center for listeners?


Candi Barlow (03:01): Sure! An Academic Medical Center is in a university setting and that’s where we originally first saw clinical trials and that was the powerhouse, if you will, of clinical trials. We had rich investigators with PIs, who steeped in the academic setting, and then there’s also that diverse patient population that is seeking out advanced care, specialized treatment within that Academic Medical Center. So that’s where we first see clinical research and then as the years have progressed clinical research has moved into these other realms where we have large site networks, who perhaps their main focus is in clinical research. They’re not necessarily tied to a health system or university. Then, we also see private standalone centers that may be in a physician’s practice, and he/she/they is just very you know dedicated to that research pathway, and they use their clinics, to support the research. Now, we also have the health systems. The hospital health systems where they have multiple disciplinaries, where many patients are coming in through different touchpoints that also now conduct clinical research. So quite the diversity, if you will, and landscape of where a patient can now receive different types of clinical research treatment plans. Great question Jake.


Jake Meyer (04:31): I love that description, that’s great. And then the last housekeeping item I’ll revisit this one we look into the billing compliance portion of the survey, but at a high level, why are we talking about budget negotiations, why is this important?


Candi Barlow (4:51): That’s a fun question, Jake. What we do is for the patient right? And we’re trying to change practice, and we want to do what is best for our patients and empower them and give them choices and options.


But at the end of the day, we also still have to run a business. We have to be able to staff and have the resources and provide different types of equipment, etc. So being able to negotiate a strong budget at the site side is key to the sustainability of that research site. Whether it be in the AMC house, the hospital, the private sector, maybe a site network, just that strength of understanding how to negotiate a budget is crucial to sustainability. I think that’s where we have a lot, maybe to offer and share in the knowledge and tips and tools.


Jake Meyer (05:54): I know and it’s so easy to get caught up in the weeds forget about the high level, the big picture, just like you mentioned.


But no, this is great! So diving into our budget results, the first topic is regarding start-up totals so how much does a site expect to receive when they do activate their clinical trial commonly called the startup fee. Our study activation survey showed that 43% of sites requested under $10,000 in start-up, 29% of sites requested somewhere between $10,000 and $15,000 and only 6% taking a little bit of a jump requested over $25,000. What’s your initial reaction to those numbers?


Candi Barlow (06:33): And you know again it’s the sites learning and understanding the effort around the startup, right? And how much it truly costs, to be able to do that task. Also having a voice if you will at the table, and knowing their value and worth of what they can ask and it not seem exceedingly robust. As we see in these numbers you’ve got a range anywhere from $10,000 to $25,000. Well that’s, that’s quite a range. So even hitting the median there you know we’re only seeing 29% and then that max at 6%. If you did the math and looked at the cost of the effort of FTEs that the work you mentioned at the beginning of the podcast, not only as budget negotiations and coverage analysis, it’s IRB reviews, consent drafting, training, and education; there’s so much that goes into the startup. So having a comprehensive cost for that, I think it’s the team’s learning how to negotiate that rate right.


Jake Meyer (07:46): Yeah and it always surprises me too. I work with several customers some of who are located in the same state. Some are a drive away from each other and this depends, whether you’re looking at ecology studies or cardiology studies. Those rates differ if it’s an observational study. But, it’s surprising even these research sites in the same locality, the same major city requests such different startup rates. Just like you said if we start getting into the fine details combing through all of those tasks that are needed, reviewing the informed consent, going through IRB routing all these documents, making sure budgeting and billing compliance is taken care of as well the legal reviews it. I snowballs. But I do want to jump into actually some of the demographics.


The startup, the budget negotiations. Specifically looking at Academic Medical Center versus everyone else, so private research sites, health systems, hospitals, we looked at which type of sites request more in startup and which can negotiate quicker, so any guesses any thoughts before I share the news.


Candi Barlow (09:11): Well, I would just say that you know it depends a lot on the startup of timelines. How many resources are available, what processes are in place, and then sometimes just by the sheer nature of the type of site, it may take longer.


Jake Meyer (09:32): Absolutely, and typically what I’ve seen a lot is just like you said, the scale of the site does matter. There’s a lot of different hoops to jump through, people who are involved, etc. So, I’ll start there actually, with negotiation, with the speed that it takes to negotiate a clinical trial budget with a sponsor. The Non-AMCs (so those private research sites, health systems, the hospitals) we found in the survey are much faster than the Academic Medical Centers.


The specific Academic Medical Centers answered that it often takes over 90 days to develop and negotiate a budget where those independent, those non-AMC, non-Academic Medical Centers are taking somewhere between 30 to 90 days.


The other difference that we found, or lack of difference, was in startup costs. I was expecting Academic Medical Centers to request more in startup but we found that there was virtually no difference. Essentially, it was Academic Medical Centers and non-Academic Medical centers are comparable in startup costs.


Candi Barlow (10:50): So, the AMC and the other health systems, research networks, private sites, etc. they all are asking it looks like about the same median of cost, but their timelines are very different right?


And perhaps you see that because of a multitude of variables that’s you know, without really having them all it’s more based on experience. And, in the AMC there are various committees, multiple layers of governance, if you will, that a trial has to pass through before it comes to fruition.


That even applies, on the accounting budget legal side where it goes through multiple layers. Just like the study review process would in an AMC because there are multiple entities, if you will, for which have governance. On the other side of the coin, where we are outside, they’re a little bit more agile. Perhaps there are standard costs that are already set and they’re already those standing cost justification letters and then there are dedicated teams, if you will, that once the trial comes in, the baton is passed to them and they’re able to start their workflows. Where on the other side of the house and the AMC: maybe they’re not able to start their workflows right from the beginning. They have to perhaps wait a little bit and then it’s their turn to start the cadence. So there is a little bit more agility, if you will, on the other side of the house. The study results show that there’s a difference in the workflow. 


Then, you also have to think about the smaller site. This single standalone site where perhaps it’s in that clinic and maybe they’re not just by nature of looking at these costs if you will they’re accepting budgets, as is and not necessarily entering into that negotiation. We see that you know just in the types of training and workshops that we do for budget negotiations and coverage analysis because they’re learning they’re young and they’re learning. So that’s perhaps maybe some of the differences that we see in the results.


Jake Meyer (13:14): I could not agree more. And, just like you touched on, I think that’s AMCs again lots of hoops to jump through, we see it all the time with those independent cancer centers, with smaller research sites… That compliance team that, that budgeting team so often on those little sites that are just one person, that person who’s looking at everything. Sometimes there’s some more flexibility there, just like you said, there are fewer handoffs, the less baton passes when it’s just one sole person, but it’s a lot to ask. 


Candi Barlow: (13:55): I was just gonna say, but you know if you think about it when we because this is also a compliance piece right? Put our compliance hat on. Sometimes because I say I might be faster, I may not have some of those other governance pieces in place to layer in some of the compliance, right? Because I’m learning and I’m growing, I am also learning to build that billing compliance piece that we talked about so often in the industry because it’s it overlays into this budget piece. 

And learning some of those skills takes time and resources. So, it’s also a growth opportunity.


Jake Meyer (14:33): So, this is a good segue into the next topic here. In general, it’s turnaround times with budget negotiations. We just mentioned AMCs on average take or they responded that they take 90 plus days to develop and build a clinical trial budget.


We broke this next portion down by startup costs requested and we found some unexpected results, the first piece sites with the highest startup costs across their clinical trials requesting above the $15,000 mark often fell into the 30 to 90 days timeline bucket.


And what surprised me the most: sites that had the lowest startup costs so under $10,000 per study on average … it’s split results one group reported that it takes under 30 days to complete: fantastic and as expected. The other chunk said that it takes over 90 days to complete studies, with the lowest startup costs any thoughts on why that is?


Candi Barlow (15:41): It may be where you’re seeing the split. Perhaps I’ve got some of the larger entities, where you’re seeing that 90 plus day, whether that be a large health system with 400-500 hospital health systems within its system, or whether it be you know the Academic Medical Centers, the larger centers, or even a large study site networks. You know, because we see some of the networks have you know anywhere from 400 to 800 plus sites that are overseeing and managing.


And then perhaps that 30 to 90-day high startup timeframe is where maybe you’re seeing some of the AMCs as well, because usually that 90-day mark is a good indicator that you’re working with a very large system, regardless of the segment, if you will, the type it’s just that they’re larger. So, it takes them more time to get through them.


Jake Meyer (16:35): And again, I wish I could butt heads with you a bit more I go in there, oh yeah. When, when I saw the high startup costs that fall into that 70 to 90 days, more or less the average timeline. To me, that just signified that hey, this is an experienced site like we’ve been talking about. Maybe they already have their budgeting piece in place, they have everything outlined, they have their PDFs justifying the costs they have very strict timeline goals. It shows versus these low startup sites where again if you have a site who just turned around these budgets.


So, I love this talk, but I do have one last topic for budget negotiations, which is why do sites believe negotiations take so long again answered by the site. Any guesses?

Candi Barlow (17:37): Why they take so long? This is exactly what we were talking about. You know it’s, it’s knowing that cost and effort in time because most sites are understaffed. This is where the industry is starting to come around where we’ve got some workforce initiatives and we’ve got some additional standards that are coming down the pike. But for now until some of those become requirements. Just like in healthcare, we would never put one nurse on a unit with 50 patients that just wouldn’t be heard of because we have different standards right? So we’re starting to see some of those same types of standards in research, where earlier you’ve mentioned, maybe have one staff member at a site who’s doing everything. We would never do that typically in any other type of environment, but we see it regularly in research which then leads to the next problem that the survey identified. So, we have a lack of staff, we have inexperienced staff, and then we have a huge turnover. Because that person is taking on more than they can you know normally would do in a workload. Then it’s overwhelming, and so, then there’s turnover and then that tenure individual is lost, because now we have a new staff again and again right, and so the cycle just keeps repeating.

Jake Meyer (19:02): I know it. So when we did ask the sites why budget negotiations take so long, that was the second most common answer, was negotiating the high costs right? The top answer that we got from our sites was they pointed to the sponsor they said it was a sponsor wait times.

Shifting gears: We also asked sites about their billing compliance and research or Medicare coverage analysis practices. So, Candi is I’m sure you’re well aware that Medicare coverage analysis, or just coverage analysis for short, shows what items services practices required by clinical trial are going to be covered by your health insurance or Medicare. If covered by insurance by the sponsoring firm, the sponsor will not need to cover these costs in the budget.

So, Candi, why is billing compliance or a coverage analysis in clinical trials, important for sites?

Candi Barlow (20:12): It’s very important. Because you can’t bill the sponsor for what services you’re being received reimbursement from that health care party, if you will, whether it’s CMS or third party payer.

Because that would be a fraudulent act because then you’re double-dipping. We can’t be double-dipping into the reimbursement fund. The other piece of that is if it’s truly a cost that is related to the trial that should not be billed to those payers, then it’s the inverse. We could be in just as much difficulty if we were billing for services that we should be willing to sponsor only. And this is a skill that takes time. It’s also a combination skill. It’s not just finance alone and it’s not clinical alone, it is a combined task. Because you have to understand what is therapeutic intent versus non-therapeutic intent, and those billing purposes.

Jake Meyer (21:23): And there are so many trickle-down effects that then get tied back into the budget, just like you were talking about. Candi based on some of the results of the survey, what are some of your most notable conclusions?

Candi Barlow (21:39): Oh. That’s a broad question. Well, you know, honestly, I would say, probably the biggest takeaway is we still have a lot of work to do. We still have a lot of education to disseminate and share. What is more exciting I think in this timeframe in research, we have more of an acceptance to this virtual platform. This is allowing us as an industry to be able to reach farther, more frequently, and have more resources available. And so, by doing that, by virtue that increases knowledge because now I have access to some knowledge and some education. Where before perhaps I was siloed in my little bubble in my world. Now, we are opening up into a new time, and where technology is bridging the vast majority of us together, because those of us in this industry, it’s a small industry, right? And we kind of say in the health system we’re always the 5% of the entire whole. And so we’re the smallest guy but by having all of this networking it’s connecting us all together, so we can share and we can talk and we can learn from one another. I would say that’s the biggest takeaway is that the survey is showing there’s so much opportunity still yet for us to learn and grow.

Jake Meyer (23:21): So, hey great conversation I’m really happy we got a chance to talk and share these important results today.

Candi Barlow (23:29): So am I this, this has been great. Just learning and sharing and having the ability to disseminate is a great opportunity, so thank you very much.

Jake Meyer (23:39): Of course, and with that, we conclude the fourth episode of Advarra In Conversations With, if you enjoyed today’s discussion keep a lookout on our social channels or Advarra.com for our next episode, thank you for tuning in.

Candi Barlow (23:55): Thank you, Jake.

Read more insights on study activation in our survey report

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