While it is well-known fact that research and development costs for new medicinal products are very high in this review we will discuss the cost analysis of clinical trials and how they are designed.
Although majority of the clinical trials are interested in drug or device efficacy and safety, the costs of the future drug or device is also part of the whole picture and it is considered from very early stage in drug development.
What types of cost analysis are used in clinical trials?
- Cost minimisation – the idea is to determine the best treatment in order to minimise the total cost of treating the disease.
- Cost effectiveness – this is a comparison between the cost of caring for the patient and the level of efficacy offered by the treatment.
- Cost benefit – a comparison between the cost of caring for the patient and the overall benefit.
- Cost utility – analysis based on all costs associated with efficacy, quality of life, greater life expectancy or increased productivity.
Clinical trials analysis normally take into consideration the direct costs only (cost of medication, clinician, nursing time costs, hospital bed, etc.) but they do not include indirect costs, which are more difficult to predict. Indirect costs include loss of productivity and earnings, loss of productivity and earnings for family members, who have to look after the patient, unexpected hospital, pharmacy costs, etc.
If the drug or medical device is successful these analysis will support the final cost on the market.
Measuring cost in clinical trials requires well design protocol, which allows the measures to be consistent for all patients. If the new treatment is not very effective may result in patient requiring more frequent consultations or additional medications. This on the other hand will increase clinician and nursing time spent with the patient.
The cost of treating a patient in clinical trials is often greater than the routine clinical practice because patients are monitored more closely and attend additional visits. However, it is also observed that the efficacy, which is established in clinical trials may not be achieved to the same level in clinical practice.
Cost analysis in clinical trials is a complex issue and there are many factors and indirect costs that will affect the overall treatment or medical device costs.
Source – Clinical Trials – General Issues
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 2 Dec 2016