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05:37
An R-Based Landscape Validation of a Competing Risk Model
Published on: September 16, 2022
Development safety update reports and proposals for effective and efficient risk communication.
Hisashi Urushihara1, Koji Kawakami
1Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Drug Safety
|April 20, 2010
Summary
Development Safety Update Reports (DSURs) will standardize safety reporting for investigational drugs. Integrating DSURs with postmarketing reports into a single, life-cycle safety report is recommended for efficiency and consistency.
Area of Science:
- Pharmacovigilance
- Regulatory Science
- Drug Development
Background:
- Periodic safety reporting for postmarketing drugs is harmonized by International Conference on Harmonisation (ICH) guidelines.
- This harmonization is expanding to investigational drugs with the upcoming implementation of Development Safety Update Reports (DSURs).
- DSURs aim to improve safety risk communication and reduce redundant reporting for US and EU regulatory submissions.
Purpose of the Study:
- To discuss an effective and efficient approach for applying standardized Development Safety Update Reports (DSURs).
- To recommend strategies for enhancing safety risk communication during drug development.
- To advocate for an integrated, life-cycle approach to periodic safety reporting.
Main Methods:
- Review of the CIOMS VII Working Group report.
- Analysis of the ICH draft guideline on DSURs.
- Discussion of optimal application strategies for DSURs and integrated reporting.
Main Results:
- DSURs are crucial for effective safety risk communication in clinical trials.
- Making DSURs accessible to ethics committees and investigators globally supports continuous review.
- Separate DSURs and Periodic Safety Update Reports (PSURs) lead to content overlap and inefficiency.
Conclusions:
- An integrated, life-cycle periodic safety report covering both development and postmarketing phases is more prudent and efficient than separate DSURs and PSURs.
- The international regulatory community should initiate a new program for integrated periodic reporting immediately.
- This integrated approach ensures consistency and integrity of safety information throughout a drug's life cycle.
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