Budgeting is not as glamorous as other aspects of clinical trial operations, yet this back-office task is key to a study’s success.

Specifically, a well-considered budget is key in maintaining solid working relationships between sponsors and clinical trial sites, notes Medidata clinical trial financial management vice president Meghan Harrington. And sponsors should maintain such relationships as they allow for future working opportunities, adds National Institute of Health and Care (NIHR) head of feasibility and start-up Laura Bousfield.  

But there are lingering challenges in budget negotiations between sponsors and sites. This can lead to clinical trial delays, or worse: fractured working relationships. Patients can end up losing out if trials are delayed due to budgeting disputes, Bousfield tells Clinical Trials Arena on the sidelines of the in-person Medidata NEXT London conference (May 24).

Imbalance in clinical trial budgets

One issue that needs to be tackled is that trial sites often feel they have little power in the negotiation process, Harrington says. The sponsor or CRO defines the anticipated clinical trial budget and then this is negotiated with trial sites.

“[Communication] is something we should improve on and think how we can bring those voices to the table in that negotiation,” Harrington adds. If there is no trust and clarity, it can sow doubt among sites if they should work with the sponsor again in the future.

Meghan Harrington and Laura Bousfield at the Medidata NEXT London conference.

Understanding the specific needs of the site is an important step in settling on a budget. The sponsors need to investigate additional costs and requests from the site, Harrington notes. For example, if a site is in a rural area, they might need a power generator to conduct the study. “Those are unique considerations that you have to plan for and allow for that kind of cushion in negotiations,” she explains.

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Budget challenges with DCT

Adding decentralised elements to a study brings its own challenges in budgeting, Bousfield says. Whether the brick-and-mortar site is shifted to a wearable device, removing many physical interactions in a formal setting, the clinical trial site is still a key study point. Consideration on what the site means in the decentralised study should be spelled out.

Decentralisation can potentially inflate clinical trial costs, Harrington says. Decentralisation requires a lot of coordination among clinical trial sites. Further, shifting specific aspects of the trial from the site to patients’ homes shift move of the study burden on patients. Sponsors should consider the time and effort patients put in decentralised trials and considered compensation, which would also add to the study budget, she notes.

Digital tools to assess the budget

In multi-country trials, sponsors would often need to juggle country or site-specific issues that can make budget planning more complicated. In the UK, together with Medidata, Bousfield helped launch the web-based interactive Costing Tool (iCT) which provides a framework of costs to support budget negotiations for industry-sponsored trials in the NHS. Such tool allows global sponsors to learn how the UK healthcare system is set up to avoid breakdowns or delays in the budget negotiations, Bousfield explains.

The iCT tool is a mandated requirement for NHS-relevant clinical trials. Bousfield says other countries have reached out to her to better understand how the tool was developed and to learn about its implementation.

While ideal, a unified global tool across all countries may not be realistic. Given the differences in cultures and global needs in every site and country, to come up with one worldwide approach will be difficult, Harrington says. Instead, the industry should have conversations about budgeting with different countries to understand their needs and give them a chance to iterate what works for them in the context of their culture and clinical research approaches, she adds.