4 Questions to Ask When Calculating The Costs of Clinical Trials

by Auxilius on Mar 29, 2022 6:00:00 AM

Clinical trials are discovery-oriented by design-exploring new treatments and offering revolutionary insights into the human body. Unfortunately, there’s another kind of discovery that often happens along the way in clinical trials – the discovery of new costs.

The problem is that it’s often difficult to accurately calculate the potential costs of a complex, multivariate clinical trial. While certain factors are established from the beginning (e.g., the number of participants), costs can change dramatically during the trial.

Why is it so difficult to accurately calculate clinical trial costs?

Unforeseen clinical hurdles: Once a clinical trial begins, there are countless hurdles you need to overcome, including timeline delays, enrollment issues, the potential for serious adverse effects (SAEs), and even last-minute protocol changes.
Outsourcing and vendor reliance: If you’re working with external third parties, services and project management costs are largely out of your control and can add up quickly.

We’ll be focusing more on the first issue today (our next blog post will cover outsourcing and vendor reliance).

The reality is, unforeseen clinical trial hurdles are not inevitable. In fact, you can exert some control over if you can plan ahead and anticipate the common variable and “unforeseen” costs of doing clinical trials.

Tomasz Sablinski, the CEO of Transparency Life Sciences, put it simply: “If you can’t properly calculate the costs of clinical trials, you can pay a hefty price.” He’s not wrong. It’s estimated the average cost of a clinical trial increased 100% between 2008–2019.

So, what can you do? For starters, make sure you’re factoring in more than just past precedents (for both FDA-approved drugs and those that failed to make the cut). But you also need to dig deeper, analyzing your post-trial launch, which can significantly impact overall costs.

1. What are the clinical trial costs by phase?

Of course, trial costs are also impacted by issues that arise in specific phases of clinical trials:

For Phase 1 clinical trials, the biggest factors were the cost of clinical procedures, central lab costs, administrative staff, physician costs, and site monitoring costs.
For Phase 2 clinical trials, the biggest factors were the cost of admin staff, physicians, registered nurses, and research associates.
For Phase 3 clinical trials, the major cost categories mostly remained the same.

2. What’s the average cost of a clinical trial?

While the past isn’t always precedent, reviewing historical costs for both successful and unsuccessful clinical trials can still give teams a glimpse of what their trials might cost.

One comprehensive study on clinical trial costs examined 138 trials, 59 of which saw new drugs approved by the FDA between 2015–2016. Of the 138 trials studied, half cost $12–$33 million.

According to a Johns Hopkins Bloomberg School of Public Health study, the median cost of pivotal (mostly Phase-3) clinical trials that established drug benefits to support FDA approval was $19 million. This was corroborated by a later June 2020 ISMP study, which found that the average cost across 225 clinical trials was also $19 million.

The Johns Hopkins study had some key insights into how therapeutic areas impacted clinical trial costs, too. On average, pivotal endocrine and metabolic disease drug trials cost $21 million. The least expensive trial was a four-patient trial for a rare metabolic disorder drug that cost just $2 million.

The median pivotal cardiovascular drug trials cost $157 million. The most expensive trial was for a heart failure drug, which cost a hefty $345 million. The numbers revealed that trials with the highest price tags aimed to create generic or slightly altered versions of successful medications.

Knowing where your trial might fall on this cost spectrum is an excellent way to begin budgeting and planning for any trial.

3. What’s the cost per patient for a clinical trial?

Per-patient costs can vary depending on the complexity of the trial. A Johns Hopkins study had some key insights into how specific trial factors impacted the overall costs of clinical trials:

On average, the cost per patient was $41,117 ($3,562 per visit).
On average, trials with fewer than 100 patients cost $6 million.
On average, trials with more than 1,000 patients cost $77 million.

The type of trial can also significantly impact per-patient costs. According to a June 2020 Institute for Safe Medication Practices (ISMP) study, per patient costs can range from just under $17,000 per patient for ophthalmological studies to over $420,000 per patient for blood trials.

Still, while therapy area, number of patients, and trial complexity can help you come to a useful benchmark, the reality is that no two trials are alike. And even the most thoughtful benchmarks are imperfect.

This is why it’s so important to maintain a real-time pulse, making constant adjustments and revisions to your cost projections as things change.

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4. What are the most overlooked costs I should anticipate?

While not every cost can be anticipated, some commonly overlooked costs are important to consider in your calculations:

Delays: Clinical trials face constant delays for many reasons (e.g., not every participant can start at the same time). These delays will not only extend the timeline but will also require additional project management and personnel costs.
Enrollment: There can be any number of reasons why you don’t hit your quota for enrollment. Maybe it’s due to a lack of demand from a specific gender, race, or demographic. It’s also possible that unexpected high enrollment in a particular region may necessitate building a new site or allocating more resources.
Monitoring: Depending on delays and enrollment issues, monitoring costs can rise substantially, as there could be more locations to monitor.
Protocols: Protocols can change due to any number of unexpected or extenuating circumstances. For example, during the pre-plan, it might be decided that the participants are not being issued a large enough dose of the medication. This may necessitate re-starting the trials or changing internal protocols going forward, both which can spike costs.
SAE: A Serious Adverse Effect in trial participants is rare, but it can still happen. In the case of permanent health problems or death, costs will inevitably increase.

Often, even the best-planned and funded clinical trials will run into one or several of these issues, which is why it’s so important for clinical trial budgets to be flexible and resilient.

How do you best prepare for the costs of clinical trials?

Unanticipated costs are just that: unanticipated. Even when you plan ahead, ongoing costs can be tricky to measure. Every single clinical trial is a different moving target.

The reality is that it’s mission-critical to properly set your expectations and prepare your budget for anything and everything at the very outset of a trial. Understanding the detailed operational costs and the likelihood of success for all your trial components greatly improves your chances of success.

That’s where Auxilius comes in. Sponsors can’t manage what they can’t measure and monitor. We know all the metrics that matter and help you analyze your data for actionable insights into trial costs, from accruals to cash management.

Instead of dealing with lagging financials, siloed teams, and a lack of top-to-bottom spend visibility, Auxilius helps you see into the future. We flag issues before they arise and anticipate costs that could have come as a surprise.

Auxilius keeps things running efficiently from start to finish, giving you real-time updates on what’s happening in the here and now with your financing, accruals, compliance, and change order specifics. That way, you and your team can focus on what matters: running a successful trial with better patient and investor outcomes.

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Topics: Clinical Trial Finance