The Predictive Value of Non-Clinical Testing

5. Toxicology Studies

5.5. Carcinogenicity Studies

Carcinogenicity studies assess how the medicine affects the generation of cancer. These studies are generally done to support the marketing application of a new medicine. However, if there is a significant concern, these studies should also be done within clinical trials to support safety. In this case, a longer clinical trial can be carried out with frequent monitoring. Finally, in some situations carcinogenicity testing can be completed after the marketing authorisation of the product.

This is generally the case for medicines that address serious diseases in adults or in children and where early access to the medicines for patients outweighs the possible risk. However, the earlier these tests can be completed, the better.