CRED Understanding Clinical Development 2024

08/10/2024

Development objective

To obtain an MA, the benefits of the drug must outweigh the risks of treatment…

…”positive benefit - risk ratio”

…“positive benefit - risk profile”

Treatment effect must be:

Clinically relevant

Worthwhile for the patient

•

“Statistically significant”

Not due to chance

•

The Organisation for Professionals in Regulatory Affairs

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Development objective

It is not mandatory to be:

• More effective than all existing treatments • Safer than all existing treatments

…but the better your drug is vs existing treatments, the higher its benefit-risk ratio and the better the chances of:

Obtaining an MA

• •

Being commercially successful

The Organisation for Professionals in Regulatory Affairs

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