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DEVELOPMENT SAFETY UPDATE
REPORT(E2F)
Seema Ahirwar
Introduction
• Development Safety Update Reports are
internationally-harmonized safety documents
covering the safety summary of medicinal products
during their development or clinical trial phase
among the ICH regions
• DSUR submitted annually, would meet national and
regional requirements currently met by the US IND
Annual Report and the EU Annual Safety Report
Objective of DSUR
Summarize management of potential
risks
Describe new safety issues
New information according with
previous knowledge
Update on the Clinical Development
Programme
Relation of the DSUR to the Periodic
Safety Update Report
 Periodic Safety Update Report (PSUR) is periodic
reporting on the safety of approved drugs
 DSUR is focus on safety of investigational drugs
 The content of the DSUR and PSUR may be
overlap
Single DSUR for an Active
Substance
• sponsor should prepare a single DSUR to all dosage
forms, strengths, indications under study with the
investigational drug
• DSUR sure that regulator in the three ICH regions
receive a uniform, high quality, comprehensive report
Periodicity and DSUR Data Lock
Point
• The start of the annual period for the DSUR is the
month and date of the DIBD
• Clinical trials going in one country and are later
initiated in any other countries, all DSUR on same
DIBD
• DSUR should be submitted to all concerned
regulatory authorities within 60 calendar days after
the DSUR data lock point
Duration of DSUR Submissions
• DSURs should continue to be submitted for as long
as indicated by national or regional laws or
regulations
• When annual reports of clinical trials no longer
required in a country, DSUR should be accompanied
by a Cover letter
Reference Safety Information
• The Investigator’s Brochure (IB) serve as the
reference safety information
• Used to assess whether the safety information
received during the reporting period remains
consistent with previous knowledge of safety profile
of IND
Format and Presentation of
DSUR
Presentation
• Title Page
• Executive Summary
• Table of Contents
1. Introduction
2. Worldwide Marketing Approval Status
3. Actions Taken in the Reporting Period for Safety
Reasons
4. Changes to Reference Safety Information
5. Inventory of Clinical Trials Ongoing and
Completed during the Reporting Period
6. Estimated Cumulative Exposure
6.1 Cumulative Subject Exposure in the Development
Programme
6.2 Patient Exposure from Marketing Experience
7. Data in Line Listings and Summary Tabulations
7.1 Reference Information
7.2 Line Listings of Serious Adverse Reactions during
the Reporting Period
7.3 Cumulative Summary Tabulations of Serious
Adverse Events
8. Significant Findings from Clinical Trials during the
Reporting Period
8.1 Completed Clinical Trials
8.2 Ongoing Clinical Trials
8.3 Long-term Follow-up
8.4 Other Therapeutic Use of Investigational Drug
8.5 New Safety Data Related to Combination Therapies
9. Safety Findings from Non-interventional Studies
10.Other Clinical Trial/Study Safety Information
11. Safety Findings from Marketing Experience
12. Non-clinical Data
13. Literature
14. Other DSURs
15. Lack of Efficacy
16. Region-Specific Information
17. Late-Breaking Information
18. Overall Safety Assessment
18.1. Evaluation of the Risks
18.2 Benefit-risk Considerations
19. Summary of Important Risks
20. Conclusions
Title Page
 DSUR number
 Investigational drug
 Reporting period
 Date of the report
 Sponsor name and address
Executive Summary
 Introduction – report number
 Investigational drug – mode of action, therapeutic
class, indication, dose, route of administration,
formulation
 Estimated cumulative exposure of clinical trial
subjects
 Marketing approval(s)? (yes/no) – If yes, number of
countries
 Summary of important risks and actions taken for
safety reasons
Table of Contents
Introduction
 DIBD or IBD
 Reporting period and sequential number of the report
 A brief description of the indication and population
being studied
 Rationale for submission of multiple DSURs for the
investigational drug
 Worldwide Marketing Approval Status
Actions Taken in the Reporting Period
for Safety Reasons
• Refusal of authorization of clinical trial
• Partial or complete trial suspension for ethical
or safety reasons
• Failure to obtain marketing approval for tested
indication
• Protocol modifications due to safety reasons
• Formulation changes due to safety reasons
Changes to Reference Safety
Information
• Significant safety related changes to IB
• Such changes include information relating to
exclusion criteria, contraindications, warnings,
precautions, serious adverse drug reactions, adverse
events of special interactions
Inventory of Clinical Trials Ongoing and
Completed during the Reporting Period
• Separate tables can be provided
– Indication
– Formulation
– Study population
• Table should contain the following information
– Protocol no.
– Clinical trial phase (I-IV)
– Status
• Ongoing
• completed
Estimated Cumulative Exposure
• Patient exposure in the development program
 Data on subject exposure to the
– Investigational product
– Active comparators
– Placebo
• Patient exposure from marketing experience
Deaths in the Reporting Period
• A list of subjects who died during participation in the
investigation
 minimum information
– Case number
– Assigned treatment
– Cause of death
Significant Findings from Clinical
Trials during the Reporting Period
• Completed Clinical Trials
• Ongoing Clinical Trials
• Long-term Follow-up
• Other Therapeutic Use of Investigational Drug
• New Safety Data Related to Combination Therapies
Other Information
• Other Clinical Trial/Study Safety Information
• Safety Findings from Marketing Experience
• Non-clinical Data
• Literature
• Other DSURs
• Lack of Efficacy
• Region-Specific Information
• Late-Breaking Information
Overall Safety Assessment
• Evaluation of the Risks
• Benefit-risk Considerations
• Summary of Important Risks
Appendices to the DSUR
• Investigator’s Brochure
• Cumulative table of important regulatory advice
• Status of ongoing and completed clinical trials
• Cumulative summary tabulations of Demographic
Data
• Line listings of SARs
• Cumulative summary tabulation of SAEs
• Scientific abstracts
Dsur presentation1

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Dsur presentation1

  • 2. Introduction • Development Safety Update Reports are internationally-harmonized safety documents covering the safety summary of medicinal products during their development or clinical trial phase among the ICH regions • DSUR submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report
  • 3. Objective of DSUR Summarize management of potential risks Describe new safety issues New information according with previous knowledge Update on the Clinical Development Programme
  • 4. Relation of the DSUR to the Periodic Safety Update Report  Periodic Safety Update Report (PSUR) is periodic reporting on the safety of approved drugs  DSUR is focus on safety of investigational drugs  The content of the DSUR and PSUR may be overlap
  • 5. Single DSUR for an Active Substance • sponsor should prepare a single DSUR to all dosage forms, strengths, indications under study with the investigational drug • DSUR sure that regulator in the three ICH regions receive a uniform, high quality, comprehensive report
  • 6. Periodicity and DSUR Data Lock Point • The start of the annual period for the DSUR is the month and date of the DIBD • Clinical trials going in one country and are later initiated in any other countries, all DSUR on same DIBD • DSUR should be submitted to all concerned regulatory authorities within 60 calendar days after the DSUR data lock point
  • 7. Duration of DSUR Submissions • DSURs should continue to be submitted for as long as indicated by national or regional laws or regulations • When annual reports of clinical trials no longer required in a country, DSUR should be accompanied by a Cover letter
  • 8. Reference Safety Information • The Investigator’s Brochure (IB) serve as the reference safety information • Used to assess whether the safety information received during the reporting period remains consistent with previous knowledge of safety profile of IND
  • 10. Presentation • Title Page • Executive Summary • Table of Contents 1. Introduction 2. Worldwide Marketing Approval Status 3. Actions Taken in the Reporting Period for Safety Reasons 4. Changes to Reference Safety Information 5. Inventory of Clinical Trials Ongoing and Completed during the Reporting Period
  • 11. 6. Estimated Cumulative Exposure 6.1 Cumulative Subject Exposure in the Development Programme 6.2 Patient Exposure from Marketing Experience 7. Data in Line Listings and Summary Tabulations 7.1 Reference Information 7.2 Line Listings of Serious Adverse Reactions during the Reporting Period 7.3 Cumulative Summary Tabulations of Serious Adverse Events
  • 12. 8. Significant Findings from Clinical Trials during the Reporting Period 8.1 Completed Clinical Trials 8.2 Ongoing Clinical Trials 8.3 Long-term Follow-up 8.4 Other Therapeutic Use of Investigational Drug 8.5 New Safety Data Related to Combination Therapies 9. Safety Findings from Non-interventional Studies
  • 13. 10.Other Clinical Trial/Study Safety Information 11. Safety Findings from Marketing Experience 12. Non-clinical Data 13. Literature 14. Other DSURs 15. Lack of Efficacy 16. Region-Specific Information 17. Late-Breaking Information
  • 14. 18. Overall Safety Assessment 18.1. Evaluation of the Risks 18.2 Benefit-risk Considerations 19. Summary of Important Risks 20. Conclusions
  • 15. Title Page  DSUR number  Investigational drug  Reporting period  Date of the report  Sponsor name and address
  • 16. Executive Summary  Introduction – report number  Investigational drug – mode of action, therapeutic class, indication, dose, route of administration, formulation  Estimated cumulative exposure of clinical trial subjects  Marketing approval(s)? (yes/no) – If yes, number of countries  Summary of important risks and actions taken for safety reasons
  • 18. Introduction  DIBD or IBD  Reporting period and sequential number of the report  A brief description of the indication and population being studied  Rationale for submission of multiple DSURs for the investigational drug  Worldwide Marketing Approval Status
  • 19. Actions Taken in the Reporting Period for Safety Reasons • Refusal of authorization of clinical trial • Partial or complete trial suspension for ethical or safety reasons • Failure to obtain marketing approval for tested indication • Protocol modifications due to safety reasons • Formulation changes due to safety reasons
  • 20. Changes to Reference Safety Information • Significant safety related changes to IB • Such changes include information relating to exclusion criteria, contraindications, warnings, precautions, serious adverse drug reactions, adverse events of special interactions
  • 21. Inventory of Clinical Trials Ongoing and Completed during the Reporting Period • Separate tables can be provided – Indication – Formulation – Study population • Table should contain the following information – Protocol no. – Clinical trial phase (I-IV) – Status • Ongoing • completed
  • 22. Estimated Cumulative Exposure • Patient exposure in the development program  Data on subject exposure to the – Investigational product – Active comparators – Placebo • Patient exposure from marketing experience
  • 23. Deaths in the Reporting Period • A list of subjects who died during participation in the investigation  minimum information – Case number – Assigned treatment – Cause of death
  • 24. Significant Findings from Clinical Trials during the Reporting Period • Completed Clinical Trials • Ongoing Clinical Trials • Long-term Follow-up • Other Therapeutic Use of Investigational Drug • New Safety Data Related to Combination Therapies
  • 25. Other Information • Other Clinical Trial/Study Safety Information • Safety Findings from Marketing Experience • Non-clinical Data • Literature • Other DSURs • Lack of Efficacy • Region-Specific Information • Late-Breaking Information
  • 26. Overall Safety Assessment • Evaluation of the Risks • Benefit-risk Considerations • Summary of Important Risks
  • 27. Appendices to the DSUR • Investigator’s Brochure • Cumulative table of important regulatory advice • Status of ongoing and completed clinical trials • Cumulative summary tabulations of Demographic Data • Line listings of SARs • Cumulative summary tabulation of SAEs • Scientific abstracts