How much does a clinical investigation cost?

MDHQ - How much does a clinical trial cost?

How much does a clinical trial cost?

Getting the budget right for a clinical investigation is both important and challenging. A well-prepared budget can help convince stakeholders, such as managers, sponsors, or potential investors, of the project’s feasibility.  

This article covers the steps for how to prepare a budget for a clinical investigation, the key cost parameters for a clinical research project, and cost drivers. 

Per patient fees

The “per-patient fees” include costs for taking informed consent, baseline patient measurements, and procedural costs such as MRIs, CT scans, echography, and other tests.  

These per-patient fees are split out over different stages or visits of the study, such as the baseline, discharge from the hospital, one-month follow-up, and one-year follow-up, which provides you with a total per-patient fee throughout the study and per type of activity.  

clinical trial cost per patient

Some activities only occur once, such as informed consent, while several activities, such as imaging, may occur several times.  

This fee can vary substantially depending on the study and can be anything from a few hundred euros to several thousand euros. 

Labour costs for site staff

You will also have to account for the staff required to conduct the project or investigation and their full-time equivalency (FTE).  

This can include site staff, research nurses, and doctors required to spend part of their working day on the clinical investigation.  

Site costs

In addition to the per-patient fees and labour costs, there are costs to cover any expenses associated with the site and various start-up activities.  

These costs won’t change much even with varying participants but will increase with the number of sites.  

Other cost drivers

Besides these costs, some other main cost drivers for a clinical investigation project are: 

  • Scientific boards and committees 
  • Electronic Data Capture (EDC) and Case Report Form (CRF) costs 
  • Independent laboratory costs 
  • Clinical Research Organisation (CRO) costs 
  • Investigational device costs 
  • Other costs such as investigator meetings, ad hoc travel, protocol amendments etc. 

The activities marked with green symbols in the spreadsheet below can be very high. They can include ethics committee fees and regulatory authority review fees.  

The costs will depend on which region and country you are working with, and you will need to multiply this cost by the number of sites and countries you include in your study.  

Clinical investigation site and start up costs calculation

Other expenses include scientific boards and committee consultation fees, safety monitoring board fees and the cost of the Electronic Data Capture (EDC) system and developing the Case Report Form (CRF) and maintaining it. 

Additional costs can include independent laboratory costs, such as an imaging core lab to analyze diagnostic imaging data and monitoring activities, often outsourced to a Clinical Research Organisation (CRO).  

Site costs also include selection visits, site initiation visits, site monitoring visits and close-out visits to the sites. Site monitoring visits will often be the biggest amount of units and total cost of the CRO activities, and sometimes it is more convenient to track this in detail in a different spreadsheet. 

And other costs, like investigational product costs, investigator meetings, record retention costs, any need for equipment or additional expenses related to protocol amendments and ad hoc travel, should also be included. 

Besides the cost drivers mentioned, you will also need to include any specific costs that may be relevant to your product, your particular type of study, or the region you are planning to do the study. 

Would you like to know more about Clinical Investigation?

Take a look at our online Clinical Investigation for Medical Devices and ISO 14155 course that focuses on good clinical practice (GCP) for the design, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the clinical performance or effectiveness and safety of medical devices.

The course covers an orientation of the clinical investigation process according to the EN ISO 14155:2020 standard and the standard’s relation to MDCG guidance documents. This practical course is suitable for anyone working in clinical research and medical device development, such as regulatory affairs associates, QA engineers, and clinical research specialists.

medical device hq instructors - Maria Nyakern

Maria Nyåkern

Maria Nyåkern, Ph.D., is a consultant, entrepreneur, and B2B service provider in the medical device industry; she is the founder of AKRN Scientific Consulting, a CRO specializing in medical devices and minimally invasive cardiovascular therapies.

Maria is also a valued and respected trainer on clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard. She has vast ‘ hands-on’ experience, having set up and managed dozens of clinical investigations, and tens of thousands of patients, for different medical devices and indications for many of the top ten medical device manufacturers in the industry.

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