How much will a clinical study cost?

In any project that requires clinical data there is always that moment when a cost estimate for the clinical study/studies is requested. At this point the response is usually prefaced by “well it depends”, and for good reason.

As with any significant project, estimating the cost has to be done based on the specifics of that project and there are no real cut and paste answers available. So what are the main considerations when trying to build an estimate? First of all a basic understanding of the nature of the trial is required.

• Is it to be conducted pre-market or post-market?

• Where  will it be conducted (which market(s) but also what care setting)?

• What is the study design (randomized controlled trial, sequential cohort design, or single cohort for example)?

• What is the scale of the study - number of patients, duration of follow-up and frequency and volume of data collection

These broad questions can probably be answered with reasonable accuracy fairly early on in the study design process.  Whilst absolute sample size may not be accurate in the early days, a clear idea on the likely primary objective and working with a statistician to understand the impact of how you measure that endpoint (e.g. is it a yes/no response or a numerical scale) will help ensure estimates are not too far out.

So having sketched out the top level details what are the things that make up the cost of a clinical study and what can be done to keep them to a minimum?

1. Costs impacted by the number of sites:

   1. Start-up costs – a reasonable estimate is between $3,500 and $7500 per site.

   2. Site Management fees – covers the cost of the Clinical Research Associate (CRA) role(s)

2. Per Patient Costs – directly impacted by sample size and can be considerably different between pre-market and post-market.

3. Data Management and Trial Management, including the cost of electronic data capture systems.

4. Regulatory filing costs - fees that can run into thousands depending on the complexity of the device and the study

5. Other costs - investigator meetings, ethics committee/IRB fees (annual renewals and protocol amendments), there may be lab fees, oversight committees, and there may also be licensing fees to pay for outcome assessment tools, eg. EQ-5D. Finally there is always the possibility of ad hoc travel needed to support study quality and progression.

So many variables make it difficult to give a generic cost. However, an article published in 2022 by Sertkaya et al. estimated that to get a complex medical device to market in the USA feasibility studies had a per patient cost of $34,059 and pivotal studies had a per patient cost of $54,332. This illustrates just how costly even the smallest study can be and therefore emphasises the need for rigorous preparation and study design to ensure the money is spent wisely and will deliver maximum value.                                                              

So what does a medical device clinical trial cost? The answer remains – “it depends”. Determining the specifics of the necessary evidence and its purpose is essential. Engaging the right experts to guide you through the complexities will ensure that your investment in early clinical research yields the greatest value. The sooner you address this in the process, the better your chances of creating an effective, efficient clinical strategy.

Evistrat Consulting is here to help so get in touch at info@evistratconsulting.com.

Reference:

Sertkaya A, DeVries R, Jessup A, Beleche T. “Estimated Cost of Developing a Complex Medical Device in the US” JAMA Network Open 2022;5(9):e2231609 doi:10.1001/jamanetworkopen.2022.31609