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An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event Sub Team FDA/QSPI Summit, March 2012

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Page 1: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

An Update from the FDA / Industry / Academia Safety Graphics Working Group:

Adverse Event Sub Team

Qi Jiang and Liping Huang

on Behalf of the Adverse Event Sub Team

FDA/QSPI Summit, March 2012

Page 2: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

The Disclaimer

The views expressed herein represent those of the presenters and do not necessarily represent the views or practices of the presenters’ employers or any other party

Page 3: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

3

Page 4: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

How to Achieve This?

Page 5: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Motivations

• Information regarding adverse events in drug development is complex

• Communicating information effectively and efficiently is crucial in detecting safety signals and helping decision-making

Page 6: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Frequently Asked Questions Regarding Adverse Events

Drug Safety

What are they?

Time to an Event?

Relationship with Dosage?

Any AEs?

Comparison with other regimens

Background Rate?

Are they safety signals?

Relationship with efficacy?

Risk Factors?

Withdraw/Interruption?

Relationship with Other AEs?

Decision Making

Page 7: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Categories of Graph

• Demographics and incidence of AEs• AE occurrence over time across treatment

groups• Dosage and exposure• Potential risk factors and their temporal

relationship to AEs • Withdrawal and interruption of treatment in

relation to the occurrence of AEs• Patient profile

Page 8: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Graphical Displays Addressing Key Clinical and Safety Issues

Page 9: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Most Frequent On-Therapy AE Sorted by Risk Difference

• Clinical Question: Which AEs are elevated in treatment vs. control?

• Type: Grouped Dotplot

• Contributed by: Frank E Harrell, Jr. modification of Amit et al 2008

Page 10: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Alternative Approach: Which AE Could Be A Safety Signal?

Dot Plot: Adverse Event Sorted by Relative Risk to address which AE could be caused by the drug

Source: Amit, Lane, Heiburger

Trt > Plc

Plc.> Trt

Page 11: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Another Alternative: Which AEs Were Elevated?

Dot Plot: Proportions of AE Occurrence Between Treatment and Placebo

Source: Michael O’Connell “Graphical Analysis and Reporting of Safety Data”

Page 12: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Adverse Event Occurrence Over Time

• Clinical Question:Is there a difference

in the time to event across treatment groups?

• Type: Grouped Trellis

Kaplan-Meier Plot

• Software: R• Contributed by:

Mat Soukup

Page 13: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Cumulative Incidence of AE by Time of Initial Onset

• Clinical Question:• Is there a difference

in the time to event across treatment groups?

• Contributed by: Liping Huang

Page 14: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Summary of Safety Subjects Exposure to Treatment

• Clinical Question:• What is the safety

profile of the drug? Are there any AEs associated with dropouts?

• Contributed by: Qi Jiang

Page 15: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

A Few More Graphical Displays Addressing Key Clinical and Safety Issues

Page 16: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Which AEs Were Elevated in Treatment vs. Placebo?

Grouped Trellis Dot Plot: AEs by Group of Special Interest

Source: Michael O’Connell “Graphical Analysis and Reporting of Safety Data”

Page 17: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Is There A Special Pattern of AE Onset?

Risk Over Time Plot for Adverse Event

Source: Qi Jiang, Amgen

Cumulative

Incidence rate

Hazard

Page 18: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Which AE Could be A Safety Signal?

Volcano Plot: Relationship Between Risk Difference and P-Value for AEs by SOCVisualizations with different adjustments for multiplicity and shows impact of multiplicity adjustments

Source: Qi Jiang, Amgen

Page 19: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Conclusions

• Clear and informative graphs enhance the ability to understand the data

• Suitable graphical presentation for adverse events could increase the likelihood of detecting safety signals

• Graphs convey information more efficiently and better meet regulatory requirements for ongoing safety evaluation

Page 20: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Conclusions

Page 21: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Special ThanksFDA / Industry / Academia Safety Graphics Working Group

Working Group Adverse Events Sub Team Members:Liping Huang (co-lead) - CSL Behring Qi Jiang (co-lead) - Amgen Fabrice Bancken - Novartis Andreas Brueckner - Bayer Healthcare Larry Gould - Merck Kenneth Koury - Merck Mat Soukup - CDER

Former Sub Team Members:Janelle Charles (co-lead) - CDER Stephine Keeton (co-lead) - PPDSuzanne Demko - CDER Navdeep Boparai - Merck Jeff Summers - CDER Yaning Wang - CDER

In addition, Amgen Safety Biostat Graphical Team

Page 22: An Update from the FDA / Industry / Academia Safety Graphics Working Group: Adverse Event Sub Team Qi Jiang and Liping Huang on Behalf of the Adverse Event

Thank You!


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