CRED Understanding Clinical Development 2024

09/10/2024

Clinical Trials

Strengths •

Controlled environment

•

Comprehensive and reliable data

•

Close supervision and proactive

• Clearly defined procedures (for AE reporting) • Denominator known (incidence and prevalence)

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Clinical Trials

Limitations •

Size (1,000 - 5,000)

• Narrow population (usually excludes children, elderly/very elderly, concomitant diseases, renal and hepatic impaired patients) • Specific well-defined indications • Few drug interaction data • Short duration (rare and delayed ADRs not detected)

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