Technical Highlights of Safety Monitoring Plans during Drug Clinical Trials

doi:10.19803/j.1672-8629.20250270

Abstract

Abstract: Objective To define the highlights of safety surveillance plans (SSP) and address key challenges to implementation of these plans. Methods The global SSP frameworks were traced, compared and contrasted. The shared issues and challenges facing implementation were identified before essential technical elements of these plans were summarized. Results A framework composed of key elements of SSP was recommended that involved such dimensions as risk identification, signal monitoring/assessment, and measures for risk minimization. Critical challenges were unveiled that included dynamic updating of plans and cross-disciplinary collaboration. Conclusion Applicants are to keep updating SSP based on advances in R&D and on the latest information about safety and validity, stick to pharmacovigilance, work towards minimization of risks and be active in communicating with regulators or agencies concerned in order to ensure the safety of subjects.

Key words: Clinical Trial, Safety Surveillance Plans (SSP), Pharmacovigilance, Investigational New Drug (IND), Innovative Drug

CLC Number:

R951
R994.11

SU Xian, LIU Wendong, HU Yangping, WANG Xiaohan, WANG Haixue. Technical Highlights of Safety Monitoring Plans during Drug Clinical Trials[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1003-1007.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20250270

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I9/1003

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