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Five Tips for Negotiating Clinical Trial Budgets in Inflationary Times
May 25, 2023
Rapid inflation and staffing shortages make it more difficult for research sites and pharmaceutical sponsors to agree to a clinical trial budget. According to Jenn Hill, Director of Clinical Site Contracting and Payments for Vertex Pharmaceuticals, inflation and high attrition rates have complicated the relationship between sites and sponsors. Sites respond to inflation with expanded budgets, extra reimbursements, and, in some cases, annual price sheets with increased rates.
Negotiating budgets takes longer as sponsors research requests to justify new budget items, and staffing shortages affect site response times. Supply chain and vendor lags are also taking their toll on sites. Here are five ways sponsors should respond in these inflationary times.
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Be mindful and communicate frequently with sites
Hill advises sponsors to empathize and consider how frustrated sites are with inflation, staffing issues, and vendor delays. “Business as usual” isn’t working in today’s market, so it’s essential to have live conversations early in the negotiation process. She also recommends continuing to meet and engage with sites after distributing the award so that sponsors stay aware of any site delays or problems. Be willing to account for additional site effort and personnel time in this environment, such as for supply chain issues and sponsor/vendor turnover. Remember that fair market value (FMV) does not mean one-size-fits-all.
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Back your decisions with industry data.
Access to detailed data is invaluable in budget negotiations and in demonstrating FMV. Sponsors should review fee requests in detail, and sites should provide documentation to justify price hikes. Reviewing individual codes and fees takes time, but tools like IQVIA GrantPlan help sponsors assess whether sites’ requests are reasonable. Vertex relies on GrantPlan’s benchmark data to lay the groundwork for their negotiations.
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Take advantage of multiple tools and benchmarks.
IQVIA GrantPlan users can take steps to make sure they use the most relevant benchmarks and take advantage of all the tools available to build their budgets.
- Leverage the Pricelist benchmarks. These are costs populated from IQVIA’s internal data sources plus publicly available data sources, including country-level economic indicators, country-level source data, actual data, and others.
- Use the Upper Limit tool, which calculates a defined percentage above a chosen benchmark level.
- Use the Cost Per Patient tool. View global industry data at a cost-per-patient level alongside your own historical data. It serves as an additional comparison against your Cost Per Patient amounts before or after building your detailed line-item budgets.
While the majority of GrantPlan users build their studies on the Median benchmark, it may be appropriate to consider using the High benchmark or the Upper Limit during current inflationary times.
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Keep your data updated.
Many budget planners begin a new study in GrantPlan by copying a previous one. While this is a time-saving feature, it’s important to remember to update your benchmark version and exchange rates after copying a previous study.
GrantPlan refreshes its budget and exchange rate data quarterly. However, metrics pulled in November 2022 showed that only 14% of the studies created or modified in 2022 by sponsors were built on the most current benchmarks available that year in August and October. Essentially, 86% of those studies may have used benchmark versions that didn’t incorporate the newest methodology or the most recent inflation rates, making them less relevant in today’s volatile market.
Benchmarks should also be updated at pivotal moments in a study’s life cycle, such as when starting a new cohort.
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Adopt the Site Budget Capture tool.
GrantPlan represents a strategic partnership between IQVIA Technologies, pharmaceutical sponsors, and contract research organizations (CROs), whereby companies that license the product agree to provide final site budget data back into the tool. Site Budget Capture (SBC) is an IQVIA GrantPlan feature that provides a direct link for users to input final budgets. It can be utilized internally as part of an approval or escalation process and/or externally with sites to negotiate directly.
SBC also ensures site-level data are available to further enable additional GrantPlan functionality, such as visibility into previously negotiated costs. Adoption of SBC by sponsors and CROs will make it faster and easier to report data back into GrantPlan, which will ultimately elevate the industry’s confidence in the timeliness and relevance of the benchmarks and speed up budget negotiations.
GrantPlan’s benchmark tools are a vital resource when negotiating site budgets. You can hear more on this topic in a lively and informative webinar recorded several months back by my IQVIA Technologies colleagues and me, along with Jenn Hill. Watch the replay of Sky-High Inflation And The Great Resignation: The Impact On Clinical Site Budgeting, hosted by Clinical Leader, or download the whitepaper on this topic.