Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations

Area of Science:

• Pharmacovigilance
• Clinical Trial Safety
• Drug Development

Background:

• Drug safety monitoring is critical throughout a drug's lifecycle, from preclinical studies to post-marketing surveillance.
• Clinical trial safety surveillance is paramount for participant protection and risk minimization before marketing approval.

Purpose of the Study:

• To review and compare global safety surveillance methods during drug development.
• To identify gaps and opportunities for improving clinical trial safety processes worldwide.

Main Methods:

• Review and comparison of international guidelines, standards, and local legislations concerning clinical trials.
• Analysis of current safety surveillance strategies and reporting requirements.

Main Results:

• Common safety surveillance strategies align with international guidelines, including systematic adverse event collection and aggregate safety reporting.
• Inconsistencies were found in local expedited reporting requirements, aggregate analysis methodologies, and health authority responsibilities.

Conclusions:

• Addressing regulatory discrepancies and harmonizing global safety surveillance can enhance the utility of clinical study data.
• Improved harmonization is expected to accelerate the development of safe and effective drug therapies.