How to Avoid Clinical Trial Delays Due to Budget Negotiations

Success of a clinical trial depends on many variables, but if a budget cannot be agreed upon between site and sponsor, the clinical trial will never be completed.¹ The process of budget negotiations can easily become a pain point due to complex protocols and multiple trial sites. There are many ways for sponsors to avoid costly delays in budget negotiations by prioritizing a few key areas.

• Provide a budget template to the site(s), if possible. The template may include common fees such as regulatory (e.g., Institutional Review Board (IRB) initial submissions, amendments, renewals, closeout), lab and pharmacy start-up costs, screen failures, other administrative/non-negotiable fees.
• Be upfront about timelines and expectations. Once negotiations begin, provide the sites with a target completion date. Because budgets may be negotiated in parallel with a clinical trial agreement, legal departments may also be involved. Setting a clear expectation from the beginning will help both the sponsor and site stay on track to meet site activation benchmarks.
• Understand the differences between a cost and a charge. The cost, typically a fixed amount, is the total dollars needed to produce a service at the institution whereas a charge is the price of the service to the sponsor and may be different.³

Site staff should thoroughly review the trial design and the effort required for execution of all trial-related tasks (e.g., completing the informed consent process and screening procedures, submitting regulatory packages as applicable, reporting adverse events, conducting trial-related visits).

• Realize that per-subject breakdowns per site will vary. The costs for one subject to complete all trial-related tasks may be higher or lower compared to other sites in a multi-site trial. There are many factors that contribute to the variability including site location, local regulations, regulated versus unregulated space, and overhead which need to be considered when approving budget items.
• Identify realistic staff needs and requirements. Aside from the investigator and research coordinators, one must understand ancillary staff that may be necessary to execute all aspects of the trial. This staff may include laboratory technicians, dedicated pharmacists who manage drug dispensation and accountability, regulatory specialists, etc. The time required for administrative and clinical obligations should be included to ensure resources area allocated appropriately.
• Recognize specialized machines and equipment that may be necessary. For example, the trial may include wearable devices which may require purchasing and accounting for data transfer and storage over the lifetime of the trial. Additionally, if the trial includes imaging, it is important to verify if the site has the capability to do this in-house or if this must be outsourced.

Summary

As mentioned in my previous article, 5 Qualities of Successful Clinical Research Sites: Site Identification and Selection Toolkit, not only do budget delays lead to slow start-up times and recruitment challenges, but inaccurate budget negotiations may also result in astronomical financial losses for both sides resulting in shared frustration.

Regardless of the site or sponsor, budget negotiations can be long and arduous. Maintaining strong communication from the planning stages through site activation and throughout the course of the trial will help reduce and potentially eliminate the need for modifications.

From the sponsor's perspective, managing budget negotiations at multiple sites is a monumental task. Addressing numerous requests and needs oftentimes vary, but when managed properly, slowdowns can be easily avoided, keeping the sponsor and site(s) enthusiastic about the trial.²

References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3061013/
2. https://www.advarra.com/blog/clinical-trial-budget-negotiations/
3. https://www.socra.org/blog/budget-development-and-negotiation-for-investigative-sites/

Jenna Brager, PhD, RN, MS, is the director of regulatory affairs at MyMD Pharmaceuticals^®. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.

Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email [email protected].

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