CRED Understanding Clinical Development 2024

14/10/2024

Considerations for the endpoint selection (Primary and Secondary)

Oncology

Preferred endpoint can differ for different types of cancer/ line of treatment

● Overall survival (OS) (gold standard) and progression-free survival (PFS) /disease-free survival (DFS) . PFS often used in diseases with very low survival rates, such as advanced metastatic colorectal cancer

Schizophrenia - endpoint dependent on claim sought

● Effects on both positive and negative symptoms: PANSS (Positive and Negative Symptom Scale)

Cardiovascular Disease Prevention

• All-cause mortality and fatal CVD event, Myocardial infarction, stroke, acute coronary syndrome

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Considerations for the endpoint selection (Primary and Secondary)

Endpoints will vary depending on Therapeutic Area

- Consult relevant CHMP Guidelines on “Clinical Investigation in the treatment of…”

Patient relevant

- Does is predict long-term outcomes for patients

Novel Endpoints

- Validated in Phase II ? (Scientific Advice/Qualification procedure)

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