CRED Understanding Clinical Development 2024

11/10/2024

Practical Considerations for Pharmacodynamic Study

Population •

Study in patients is more informative • For certain indications may be observed in healthy subjects or used surrogate methods for example ex vivo stimulation • The exact indication is not established • Small sample size

Wide net approach •

Multiple biomarkers tested in a panel • Requires robust statistical methods for the small sample size • Some variabilities may not be represented • Have to be confirmed later

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Practical Considerations for Biomarker Selection

Invasiveness vs ease of obtaining samples – related to frequency and complexity of testing

Multiplex analysis

Complex bioA test

Cognitive test

IMAGING

Cost

Computer assessment

Urine samples

biopsy

Blood sample

Relevance to the study - type of disease and drug Variability – intra and inter patient

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