CRED Understanding Clinical Development 2024

09/10/2024

Safety Goals in Clinical Trials

• Detect and characterise common Adverse Drug Reactions (ADRs)

Determine frequency

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• Determine tolerability in volunteers and patients – whether event resolves or improves on repeated dosing, does IMP have to be withdrawn

• Identify any predisposing factors for certain ADRs

• To make safety comparisons with competitors

• PK components, dose relationship

The Organisation for Professionals in Regulatory Affairs

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Safety Goals in Clinical Trials

• Ensure safety of patients in on-going clinical trials is maintained • Collection, analysis and reporting of safety data from individual trials. • Annual review of safety data in DSURs • Summarise safety data from all trials in the summary of clinical safety in the MAA documentation. • Forms the basis of the safety specification risk management plan for MAA and data for the product label.

The Organisation for Professionals in Regulatory Affairs

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