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(CIOMS)
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Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials Report of CIOMS Working Group VII CIOMS Geneva 2006
Vision I Introduction and Overview
a. Rationale
for the CIOMS VII Project
II General Principles for a DSUR
a. Administrative
Matters
b. Technical Content
III Development Safety Update Report
Model a. Title Page b. Table of Contents c. Executive Summary d. Introduction e. Worldwide Marketing Authorisation Status f. Update on Actions Taken for Safety Reasons g. Changes to Reference Safety Information h. Inventory and Status of Ongoing and Completed Interventional
Clinical Trials i. Estimated Patient Exposure in Clinical Trials j. Presentation of Safety Data from Clinical Studies k. Significant Findings from Interventional Clinical
Trials l. Observational and Epidemiological Studies m. Other Information n. Information from Marketing Experience o. Late Breaking Information p. Overall Safety Evaluation q. Summary of Important Risks r. New Actions Recommended s. Conclusions t. Appendices to DSUR Appendices
Vision
Regular and timely review, appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Whereas the overall goal of a clinical development programme is to characterize the benefit-risk relationship of the product in a particular patient population, the risk to individual trial subjects is a critical consideration during product development, at a time when the effectiveness of a product is generally uncertain. By conducting an overall appraisal of safety data at regular intervals, risks can be recognised, thoughtfully assessed, and appropriately communicated to all interested stakeholders, to support the safety of clinical trial subjects. Although the regulatory authorities in the EU, US, and some other locations currently require the submission of a periodic safety report during the conduct of clinical trials, usually on an annual basis, there are substantial differences in the format, content, and timing of the different reports. Thus, the CIOMS VII Working Group is proposing an internationally harmonized document, namely, the Development Safety Update Report (DSUR), which is modelled after the Periodic Safety Update Report (PSUR) for marketed products. The Working Group envisions that such a report would summarize the safety experience and explain any actions proposed or taken for a clinical trial, or for an entire development programme. Although the scopes of the reports would differ, the Group envisions that both commercial and non-commercial sponsors would prepare and submit DSURs. By design, these reports will enable a seamless transition for communicating safety information to relevant stakeholders, starting at the early clinical development stage and, by aligning the DSUR with the PSUR, continuing throughout the post-approval period. It will also lead to enhanced public health protection by ensuring proper focus by all sponsors and clinical investigators on ongoing safety review throughout the life-cycle of a product, while eliminating unnecessarily different, yet redundant requirements. The CIOMS VII Working Group hopes that its proposals on the creation of a DSUR and its content and format will be endorsed and universally implemented by all stakeholders. The CIOMS VII Working Group also envisions a further, more ambitious objective, whereby the DSUR and PSUR are integrated into a single harmonized safety report that would cover a product throughout its lifecycle. Proposals are made for future development of such a document and process.
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