On November 17, 2022, Clinical Leader and IQVIA Technologies led a one-hour webinar on the topic of clinical site budgeting and fair market value (FMV). Clinical trial sponsors and research sites submitted numerous questions throughout the webinar.

IQVIA GrantPlan experts Sharon Gordon, Director of Cost Benchmarking and Site Contracting; Morgan King, Data Analytics Leader; and Jesse Glass, Manager of Data Sciences and Cost Benchmarking, were joined by Jenn Hill, Director of Clinical Site Contracting and Payments for Vertex Pharmaceuticals. They shared their extensive experience and answered questions regarding benchmarking data available in IQVIA GrantPlan and how to account for sky-rocketing inflation and attrition rates. This Q&A contains questions directed to Jenn Hill and those directed to the GrantPlan team.

Questions Answered by Jenn Hill, Director of Clinical Site Contracting and Payments for Vertex Pharmaceuticals

Q: Does Vertex use other data or techniques alongside GrantPlan?

A: We start with GrantPlan, using multiple data points within the tool. When we do our additional build, we determine, based on therapeutic area and exposure to sites, what data from GrantPlan we will start with, and that’s what we call our master budget.

From there, we look at whether we’ve negotiated with the site before, whether it’s in the same therapeutic area, where we landed on the procedural cost, and what we can expect for the site cost. That helps us tell a story about where we should start. And that allows us to lay the groundwork for a healthy discussion or negotiation. As we hear back from the sites, we consider all of the shifts in the landscape because even if the last negotiation was within the previous three months, there could have been significant market changes.

Or, it could be that it’s been a lot longer and was in a different therapeutic area. There are a lot of layers to the consideration of what information we lead with, but we like to think that it’s a conversation, and it’s something that we should be fluid about and make sure that we’re being thoughtful.

Q: How do you talk to regulators to ensure we’re not being coercive and not overpaying sites, which may look like we are over-incentivizing?

A: We’re trying to ensure that when sites present fees excessively higher than what we’ve seen in the past, we’re going through a rigorous review. Do you have what we’re looking for — site policies and documentation showing that these are reasonable work or time fees? We ask for justification. We ask for pass-through expenses and items to be presented. We look to our medical monitor team and internal clinical team members to assess if this is accurate for the time spent doing the work.

When you think about the cost that we present versus what we get back, it’s taking time to slow down and assess the viability of the fees. And sometimes that does look like us reaching out to GrantPlan and saying, ‘Hey, we have some requests for some fees that we can’t find codes for, or maybe the codes we’re looking at don’t seem to reflect the fees accurately. Are we getting it right?’ And that’s the partnership, the conversation we have with them to ensure we’re getting it right.

Based on recent discussions, there are some fees we should be adjusting because the baseline fees we use need to account for complexities that we should be considering. We’re not necessarily conversing with regulators to ask how we ensure this is not incentivizing. Instead, we’re making sure that internally what we’re representing in the budget matches the protocol and doesn’t bleed into areas where that could become a point of concern for us as a business.

Q: Do you find that sites you pay a higher rate to, or with whom you negotiate contracts faster, are higher enrolling sites?

A: How the question is worded leads me down a road I don’t like. I’ve been asked questions like, ‘Can you pay a higher rate or add a line to fast-track this site to get them to participate or to get activation pulled in more quickly?’ And to answer that, no, we can’t increase the rates in Site A more than Site B because then you will run into regulatory issues. Are there ways that businesses could navigate that discussion internally? I argue that you end up skewing the data because now you’re paying for speed. It gets tricky.

Questions Answered by the IQVIA GrantPlan Team

Q: What is the lag between negotiation and incorporation into IQVIA’s benchmarks?

A: To answer this question, we took the start date from clinicaltrials.gov and correlated that to the budgets provided by GrantPlan. We found that 50% of the data was incorporated into GrantPlan’s benchmarks within three months, 25% between three and six months, and the remaining 25% in greater than six months.

Q: Is the overhead percentage part of the total site cost? And what is the average overhead percentage you are seeing now?

A: When we process the data, we extract overhead from the site cost. There are a couple of cases where we see the overhead applied on a country level, or it can be applied on a line-item level, but we do extract that information. Our overhead data update is performed quarterly, and we provide a list of overheads, including the minimum, average, and maximum by country. These numbers are available on our help page. Every time we update the overhead, we create a report for clients to review these averages. And yes, we see increases in the average overhead percentage.

We pull the data the same way we do our actuals, and we look at a considerable period, about two years, to keep it as relevant as possible. So, when we’re looking at it year over year, we see those increases more than anything else. But even looking at it in the two-year time window, we see an average increase. It’s also essential when you look at that report to see that the maximums change as well. And so, you can have a lot of variation, sometimes quarter over quarter, to see the new maximum.

Q: For non-procedures, what is the trend of what’s included? I see a lot of budget builders, including what is typically considered procedures versus the administrative burden.

A: It can vary because non-procedures are mixed bags that include items not done on the patient, such as personnel time and reimbursement costs. Essentially, it’s a mix of a few things. We’re working with the statistics team to add more specific nomenclature to differentiate them. If it’s not a site cost and not touching the patient, it’s included in non-procedures. Now, do we have more non-procedures than procedures? No, but most is personnel time; 50% to 60% of the non-procedures are personnel time per hour or per visit.

Q: Site costs are likely labor costs, which may have grown at a different rate than national inflation. Do you have labor cost inflation in other sectors for comparison?

A: Agreed. The most nuanced level of inflation adjustments possible provides the most interesting analysis. Although we can often obtain more sophisticated inflation measurements for the U.S. or other economically developed countries, getting granular data for all countries is often difficult or unreliable. We like to begin the analysis with what is most widely available.

Q: In the U.S., costs for smaller private-owned sites differ from hospital-based/university-based sites, yet we use the same benchmark. Is there a workaround for this?

A: Although we do not currently have an analysis outlining the cost differences both for line items and overhead percentages by site type, we are in the discovery phase of adding metadata to potentially allow more granular benchmarks based upon it.

Q: If there is a lag of three to six months (for 50% of the data), how do you claim the benchmarks are keeping with inflation?

A: The variance in site benchmarks far exceeds the rate of change. Analysis of historical benchmarks shows that they have tracked with inflation. Increased use of Site Budget Capture will get data immediately into benchmarks and reduce that delay.

Q: Do you believe sites should modify pricing for inflation as it’s adjusted in real time, or do you favor yearly pricing adjustments and predictions?

A: Our role is an objective provider of benchmarks. Based on our observations, if and how adjustments to a site budget are made is very specific to each sponsor.

Q: What’s the usage of each benchmark percentile in GrantPlan?

A: Approximately 70% of forecasted data use the median (50th) benchmark, more than 20% use the high (75th) benchmark, and less than 10% use either the 90th percentile or the Benchmark Upper Limit Tool.

Q: Can GrantPlan track negotiated costs for each site and provide reporting to see all costs per visit across all sites with executed Clinical Trial Agreements?

A: If the Site Budget Capture module is used, GrantPlan users can easily track these costs, and our Data Administration team can provide such reports. If Site Budget Capture is not used, we can only report back data provided to us.

Q: Are the procedure costs already built-in with the inflation rate (based on actual recent accepted rates by the sites), and therefore there’s no need to add a percentage based on the Consumer Price Index?

A: GrantPlan provides three benchmark sources: Price Lists, Actuals, and Internal Budgets. We’ve already built inflation into the Price List source and are currently updating our methodology to incorporate inflation for Actuals and Internal Budgets.

Q: Is overhead part of site costs? What is the average overhead percentage you are seeing now?

A: GrantPlan procedural costs and overhead costs are captured separately. Overhead costs vary a bit from country to country, so we recommend checking the current applicable overhead benchmarks as you create or modify each study. You can also check the GrantPlan Overhead document in the Knowledge Center, updated quarterly.

Q: During the pre-award grants estimation stage, sponsors often ask, ‘How confident are we with our estimation?’ Any thoughts on it? And, how accurate is GrantPlan tool estimation compared to other tools?

A: A key variable in confidence is the amount of data contributing to the benchmark. GrantPlan users may refer to the Number of Data Points Report document in the Knowledge Center to see the amount of data contributing to a given benchmark, gauge their confidence in their estimations, and compare GrantPlan’s accuracy to other tools.

Q: Do you find that sites you pay higher rates to negotiate contracts faster and/or are higher enrolling sites?

A: Speed of patient enrollment and negotiations are not metrics that GrantPlan is designed to capture.

Q: Considering the lag time between contract execution and contract data entering your database, do you recommend adding inflation to recent event benchmarks? If so, should we increase by more than the inflation percentage due to clinical research prices increasing faster than inflation?

A: We don’t recommend adding an inflation adjustment to present benchmarks.

Q: Can you pay for overtime as a line item to fast-track negotiations?

A: If overtime is expected to be required of site staff to complete study requirements, it would be appropriate to reflect it in the budget. Acknowledging that up front helps complete negotiations more quickly.

Q: A GrantPlan user could employ the Study Complexity tab to add a percentage for inflation (when documented) that shows the increase above established benchmarks, correct?

A: The Complexity Factor tool is best used to consider the complexity of certain study elements to ensure your budgets are appropriate rather than using it to add an inflation factor.

View the recorded webinar, including this Q&A, on-demand at Clinical Leader.