CRED Understanding Clinical Development 2024

14/10/2024

Patient Population

• Type of patient depends on stage of development • (Phase I, II, III, IV; real-world ?)

• Inclusion criteria

• Target indication (enrichment)

• Exclusion criteria • Factors interfering negatively with the trial • Balance regulatory requirements, ethical & operational consideration

The Organisation for Professionals in Regulatory Affairs

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Considerations for Control/Comparator section

Study should have adequate control group

Comparisons can be made to: ● Placebo

● No treatment ● Active controls ● Different doses of drug under investigation ● Historical (external) controls

Choice depends on study objective, available treatments, guidance, precedence, regional differences , HTA requirements

ICH E8 General Consideration of Clinical Trials

The Organisation for Professionals in Regulatory Affairs

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