Clinical trial activation involves a host of tasks, from institutional review board (IRB) tasks and consent form development to research budgeting and billing compliance. One of the critical challenges research sites face is managing budgeting and billing complexities. This post delves into insights from the recent Advarra Study Activation Survey, exploring site budget negotiations, startup costs, timelines, and Medicare coverage analysis (MCA).
The Budgeting Dilemma: Startup Costs and Negotiation Challenges
A key area of concern for clinical research sites is determining the appropriate startup costs and negotiating budgets with sponsors. The Advarra survey revealed a broad range of startup costs requested by sites, with 43% of sites asking for under $10,000, 29% between $10,000 and $15,000, and 6% exceeding $25,000. While the figures vary, the common thread is many sites struggle to accurately assess their value.
Clinical research sites often underestimate the effort required for clinical trial startup. Beyond budget negotiations, the process includes IRB reviews, informed consent development, and staff training. The survey shows many sites are still learning to advocate for themselves, negotiating budgets reflecting the true cost of their work. Variability in requested startup fees even occurs among sites located in the same geographic region.
The survey also compared different types of clinical trial sites, including academic medical centers (AMCs) and independent research centers. While many expected AMCs to have higher startup costs, the survey found little difference between AMCs and non-AMCs in terms of fees. However, the timelines for budget negotiations told a different story. AMCs reported taking more than 90 days to negotiate budgets, while non-AMCs typically completed negotiations within 30 to 90 days.
Why Budget Negotiations Take Time
One of the more significant revelations from the survey was the time it takes to finalize budget negotiations. Research sites often cite two main reasons: sponsor delays and staffing issues. For smaller sites, especially those with only one or two staff members, managing negotiations alongside other responsibilities can be overwhelming. This can lead to high turnover, as overworked staff members leave, causing further delays in the negotiation process.
The complexity of clinical trial budgeting cannot be overstated. For many smaller research sites, budget negotiations are not only time-consuming but also hindered by a lack of experience. Larger organizations, like AMCs, often have to navigate several layers of governance, which adds to the delays. These organizations may have to route budgets through multiple committees and legal reviews, slowing the process.
The Importance of Medicare Coverage Analysis
Billing compliance, particularly MCA, is another critical element impacting clinical trial budgeting. MCA determines what costs are covered by health insurance or Medicare versus those the sponsor covers. Ensuring billing compliance is crucial to avoid fraudulent billing practices, such as charging both the sponsor and Medicare for the same service.
This is not just a financial task but a clinical one as well. It requires collaboration between clinical and financial teams to accurately assess what can and cannot be billed to Medicare. The skill required to perform this analysis correctly can take years to develop, further complicating the budgeting process for less experienced sites.
Opportunities for Growth and Standardization
Despite the challenges, the survey results also highlighted opportunities for growth and learning within the industry. However, clinical research sites are beginning to adopt more standardized processes, especially around workforce management and billing compliance. These improvements are crucial for reducing the time it takes to negotiate budgets and ensuring compliance with MCA.
One of the more promising trends is the industry’s increasing acceptance of virtual platforms, which allow for greater collaboration and resource-sharing among research sites. This can help smaller, less experienced sites gain access to the knowledge and tools they need to negotiate more effectively and comply with billing regulations.
The results of the Advarra Study Activation Survey provide valuable insights into the budgeting and billing challenges faced by clinical research sites. From negotiating startup costs to managing MCA, the complexities of clinical trial activation require sites to be well-prepared and knowledgeable. While larger institutions may have more resources at their disposal, smaller sites often have the advantage of agility, allowing them to negotiate more quickly. However, both face challenges related to staffing and the intricate nature of budgeting and billing in clinical trials.
