Clinical development

Clinical trials are designed and conducted to answer several questions. The main questions that must  be answered are:

• Does the candidate medicinal product reach the site of action? This includes analysis of absorption, distribution, metabolism, and excretion.
• What is the safe therapeutic window of the product?
• Which dose could be safely administrated and in what schedule?
• Is the functional and/ or clinical effect of the candidate medicinal product reached? If a product is functionally effective, this does not automatically mean it is also clinically effective. For instance, a chemotherapy can reduce the tumour, but not give a survival benefit. Other endpoint like side effects and quality of life are then important factors.
• Is the intended population the correct population, and how does variability in response changes the development?

For each candidate medicinal product, there are more specific questions. The questions then need to be translated into clinical trials in which endpoints, comparative treatment, inclusion and exclusion factors, etc. must be determined. The LUMC has a lot of experience in designing and conducting clinical trials for all types of diseases.