The use of Radiologic Imaging in the subject screening period is significantly increasing, as there are benefits that deliver a return on this investment and regulatory agencies have issued guidance to protect potential subjects who might appear to have an increased risk for side effects.
- Trial enrichment (e.g. enrol subjects with a certain disease stage which is expected to respond (faster or statistically more sound) to the drug.
Example: Enrolment of subjects for which the hippocampus size and cognitive test show the required evidence for an AD Trial.
- Exclusion of diseases clinically mimicking the target disease, but which are expected to show no effects from the investigational drug.
Example for AD: Exclude vascular dementia / heavy load of WM damage.
- Exclusion of patients/subjects who might suffer from an increased safety risk
Example: Subjects with micro-haemorrhages prior to trial entry might have an increased risk of (new) haemorrhages in the brain. The current FDA guideline allows subjects to have a cut-off maximum of 4 micro-haemorrhages in the brain for a AD trials with amyloid targeting drugs, 5 micro-haemorrhages leads to exclusion.
This detailed screening guideline makes independent consistent reading extremely important. The quality of the reading is highly depending on the choice and quality of the MRI sequences. NeuroScios knows exactly what it takes to do this.
Exact rules and consistent application of those rules for Screening are extremely important. Just the practical topic with exclusion because of benign space occupying lesions already requires a lot of attention and suffers for locally varying interpretations.