Clinical Trial Cost Per Patient

How much does it cost to conduct a clinical trial?

The cost of conducting a clinical trial varies drastically depending on a multitude of factors, such as:

• the phase of the trial (i.e., phase I, phase II, phase III, post-marketing/phase IV)
• therapeutic area
• complexity of the study design
• location and number of study sites
• length of the trial and number of visits required
• sample size (number of participants involved)

Thus, the answer to “how much does a clinical trial cost” is highly variable. A 2020 study was reported in the journal BMJ Open, for which the authors used a software tool developed by IQVIA, which is used to estimate the costs of trials, to project the costs of 225 pivotal trials (i.e., phase III clinical trials) conducted in relation to 101 therapeutic agents approved by the FDA between 2015 and 2017. The cost of a single phase III pivotal trial was estimated to be between $12 million and $33 million USD (median $19 million USD).[1] Since some drugs required more than one pivotal trial, the median cost of necessary supporting trials per approved drug rang in at $48 million USD.

It’s important to note that this study was based on cost estimates, and focused on industry-sponsored phase III trials. Since later-phase trials tend to be more expensive than phase I and phase II trials, these numbers may not be representative of the costs of smaller trials, nor other financing structures such as those in investigator-initiated trials (IIT) or academic-run trials.

Drivers of clinical trial costs

Besides trial phase, therapeutic area also influences the cost of a trial, with some areas of research tending to involve more costly studies. This could be due to a number of factors, such as the need for specialized equipment, expensive laboratory tests or medical procedures, need for longer-duration trials, etc.

The same study cited above revealed that the two main cost drivers of the cost of a clinical trial were:

1. Sample size; the number of patients needed to be enrolled to support statistically sound results
2. Number of trial sites; the number of physical sites contracted to conduct the study

For each of these factors – i.e., increasing the number of participants or the number of sites – the cost of the trial increased exponentially.[1] A separate study indicated that the top three cost drivers – apart from site overhead costs and the costs of monitoring by the sponsor itself – were clinical procedure costs (15% to 22%), administrative staff costs (11% to 29%, and site monitoring costs (9% to 14%).[2]

What is the average cost of a clinical trial?

The average cost of conducting a clinical trial in general (i.e., across phases and therapeutic area) is essentially impossible to specify with one value due to the high variability across numerous influencing factors, as mentioned above. Investigational drugs often pass through four distinct phases of clinical trials (phase I-IV), each tending to be progressively more expensive than the prior, largely due to enrolling a greater number of participants.

A study published in 2016 estimated the average costs of phase I trials conducted in the US (between 2004 and 2012) at between $1.4–6.6 million USD, while phase II trials were more costly at $70–19.6 million USD, and phase III trials costing from $11.5–52.9 million USD.[2]

Thus, the average cost of a clinical trial depends primarily on the phase of the trial, the therapeutic area being studied, the number of participants, and the number of study sites required. The cost of a single trial seems likely to range between about $1.5 million USD and $53 million USD, although realistically there is no hard upper limit to this value (although there is likely a lower limit, at least for interventional clinical trials).

How can the cost of a clinical trial be optimized (reduced)?

Considering the above factors as the main cost drivers of clinical research, it could be generalized that trial costs could be cut down by:

• Formulating the research hypothesis and designing the study in such a way that the minimum number of participants are required to reveal a drug effect (or establish safety, etc.)
• Minimizing the number of study sites, either by enrolling fewer participants, or limiting the geographical range, or by adopting aspects of decentralized clinical trials and hybrid trials, thus requiring fewer sites (or none at all).

However, there are numerous other factors that come into play here, and a deeper discussion is beyond the scope of this article. We have published a related piece regarding clinical trial budgets which may provide useful information for trial sponsors interested in the different costs involved in conducting a clinical trial.

How much does it cost per patient in a clinical trial?

As mentioned in the previous section, the number of patients enrolled in a trial is one of the main cost drivers. That’s largely because, as we touch upon in our article on clinical trial budgets, per-patient costs are one of the main expense categories involved in a clinical study. Per-patient expenses relate to things such as:

• Recruitment, screening, enrollment, and consenting procedures
• Staffed study visits
• Medical procedures, laboratory tests, and study interventions
• Routine medical care
• Any compensation for participation, or reimbursement of out-of-pocket expenses incurred to patients
• Costs of the study drug and material supplies

Evidently, the overall cost of a clinical trial will increase proportionally as the per-patient expenses increase. More importantly, however, the overall cost can increase exponentially as the number of enrolled patients increases, since the per-patient costs effectively (more or less) double for each additional participant.

Average clinical trial cost per patient

In consideration of the above, providing a precise numerical value to represent the clinical study cost per patient is challenging, owing to the vast heterogeneity in study-specific factors. Based on data from 2008 to 2011, across all therapeutic areas, the cost-per-patient ranged from $15,000 to $47,500 USD.[3] A more recent estimation based on 2015-2017 trial data suggested a median of clinical trial costs per patient of about $41,500 (interquartile range $29,900 to $75,000 USD).[1]

How much does it cost to recruit a patient to a clinical trial?

Patient recruitment can be one of the most expensive aspects of conducting clinical trials, and clinical trial recruitment cost per patient can vary. Costs associated with recruitment encompass various activities, including advertising, pre-screening and screening against the trial’s eligibility criteria, obtaining informed consent, and initial baseline evaluations.

The overall clinical trial recruitment cost per patient also varies based on specifics of the trial, like the prevalence of the disease in the population (where it is harder to find participants for rare-disease studies), and could range from a few hundred dollars up to thousands of dollars per participant enrolled. It's also important to account for the costs of unsuccessful recruitments, i.e., screen failures. A screen failure implies that the potential participant was still screened, which could have involved a simple assessment of demographic characteristics or might have required costly medical tests. Since screen failures add to total expenditure without any return on investment, it becomes even more important to develop efficient recruiting strategies.

Conclusion

Clinical trial cost per patient can be conceptualized as a function of nearly innumerable variables, which will be defined by the specific details of the study. The main drivers influencing clinical trial costs per patient are likely to include the phase of the trial, the therapeutic area being investigated, the number of study visits involved, and the costs of medical assessments, tests, and the study intervention, since the cost of such procedures apply to each individual participant enrolled in the study.