CRED Understanding Clinical Development 2024

14/10/2024

Innovative/Complex Trial Designs

Adaptive Design - Studies planned with design modifications based on results of interim analysis Master Protocols - Design and conduct of clinical trials intended to simultaneously evaluate several investigational drugs and/or disease types

Example: Cancer trials, Covid-19 trials

Fig 1 and 2: https://www.fda.gov/media/120721/download

The Organisation for Professionals in Regulatory Affairs

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Use of Real-World-Data

• Medicines development costs are rising

• Precision medicines – smaller, more targeted patient groups

• RWD/RWE – potential to supplement data ? How ?

• Disease prevalence • Patient populations • Standard of care • External control arm for CTs • Long term safety / efficacy insights

The Organisation for Professionals in Regulatory Affairs

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