One of the most challenging tasks for clinical data managers and the study team is identifying and accounting for all possible costs to ensure the trial runs smoothly and within budget. However, despite best efforts, various unexpected costs still arise. In this article, we look at examples of these hidden costs and how to mitigate them during the planning phase.
This is the third of a series of articles exploring how to navigate some of the key challenges faced by clinical data professionals and how Viedoc can help.
Examples of hidden charges
Unexpected costs in clinical trials tend to fall into three areas—recruitment and retention of participants, administration of the study, and the study protocol itself. Here are some examples of situations that may trigger extra costs:
Participants
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Higher than expected dropout rate
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Low accrual of study subjects can increase costs per subject
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Failing to keep patients engaged
Administrative
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Activities such as training, site assessments, and audits
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Higher than expected screen failures
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A study may require specific equipment that needs to be purchased, delivered, and collected at the end
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Study sponsor companies often have to pay retail prices for comparator and co-therapy drugs that can be high
Study
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Multiple amendments to the study protocol
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Delays in IRB approval, contract approval, or the study itself
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Unclear and complex protocols can make it difficult to generate quality data
How to manage hidden charges
One way to anticipate and account for extra unexpected costs is to go through a detailed checklist looking at all aspects of your upcoming trial. This will lead to smoother trial execution, more accurate financial management, and ultimately, a better understanding of the intricacies of clinical trial budgeting can help ensure success. To help navigate this process, here’s a detailed checklist that can be adapted for your specific study:
- Streamlined billing process:
Ensure that all billing procedures are clear and transparent. Having a streamlined and automated billing system helps prevent confusion and reduces the likelihood of unexpected fees. - Consistency in contract terms:
Review your contract terms for consistency, particularly when it comes to billing for additional units or services. Clear terms can prevent miscommunications and ensure predictability in pricing. - Predictability in costs:
Anticipate any potential changes in the trial design that could result in additional costs. Predictable pricing from the start helps avoid surprises as your study progresses. -
Transparent pricing structures:
Make sure you have a clear understanding of the pricing structure, especially regarding ad-hoc activities or adjustments in trial design. A transparent breakdown of costs will aid in more accurate budgeting and financial planning. -
Clear communication channels:
Maintain open communication between the study team, CROs, and sponsors. Transparent discussions about any changes in the scope of the study, and their impact on costs, can help avoid misunderstandings. -
Regulatory and ethical submissions:
Consider the potential costs of regulatory and ethical submissions, including any amendments. These fees can accumulate quickly, so early budget planning for these aspects is essential. -
Stable cost management:
Aim for stability in your cost management by using predefined activities and unit pricing. This can help mitigate the risk of fluctuating costs throughout the lifecycle of your study.
So, what’s the answer?
Budget management is a complex and challenging task for clinical data managers and the study team, but using a detailed checklist during financial planning to make sure potential hidden costs are incorporated into your budget can make the process more manageable.
At Viedoc, we pride ourselves on being transparent about study costs, which aids in accurate budgeting. Our platform offers comprehensive tools for data analysis and project tracking, which are essential for maintaining proper forecasting and managing potential slowdowns before they occur.
Viedoc stands out among EDC providers by leading the charge in transparent cost management, setting a new standard for innovation and customer success. Our approach to ad-hoc activities and unit costs isn't just about billing—it's about a commitment to transparency, fairness, and partnership. We aim to enhance our clients’ experience and ensure they have the support they need every step of the way. As a dedicated ally in navigating the complexities of clinical trials, Viedoc empowers clients to achieve their goals with confidence, ease, and clarity.
