Statistical Considerations for Premarketing Risk Assessment May 16, 2024

Virtual | Virtual

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• Date: May 16, 2024
• Time: 1:00 PM - 2:30 PM ET

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ABOUT THIS WEBINAR

This presentation will:

• Describe important statistical considerations in the premarketing assessment of drug safety. The safety profile of a drug evolves over time through gained experience and increased exposure. The use of diligent planning for safety and rigorous assessment of maturing safety data optimizes the ability to characterize the safety profile of a drug
• Cover the importance of planning for the safety assessment of a drug. A focus will be on planning to assess key risks in confirmatory trials to improve the quality and reliability of the safety data collected for these risks. Such a task requires clear specification of the key risks, operational definitions of the risks and plans to ascertain them, and other trial design and conduct considerations to facilitate their assessment at trial completion
• Address statistical considerations in the analysis of safety data, primarily adverse event data. Analysis of adverse outcomes is not a simple calculation of crude proportions of the number of participants experiencing the event. Rather, it requires careful consideration about the approach to analysis, including topics such as handling of treatment discontinuation, using data from multiple trials, defining summary measures of incidence, and choosing statistical methods to estimate the incidence and corresponding uncertainty

INTENDED AUDIENCE

• Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on clinical trial safety analyses for new drug marketing applications
• We will not discuss trial data for generic drug applications

TOPICS COVERED

• How trial design can enhance the assessment of safety data
• The importance of tailoring the analysis of safety to align with trial design
• The use of appropriate statistical analysis approaches, including topics such as the choice of metric for estimating risk, handling treatment discontinuation, and integrated analyses

LEARNING OBJECTIVES

• Identify how trial design can enhance the assessment of safety data
• Cite the importance of tailoring the analysis of safety to align with trial design
• Explain appropriate analysis approaches to assess causal relationships between drug and adverse outcomes

SPEAKERS

Gregory Levin, Ph.D.
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Science (OTS)
Center for Drug Evaluation and Research (CDER) | FDA

Mat Soukup, Ph.D.
Deputy Director
Division of Biometrics VII
OB | OTS | CDER | FDA

FDA RESOURCES

• FDA Guidance Benefit-Risk Assessment for New Drug and Biological Products (October 2023)
• FDA Guidance Premarketing Risk Assessment (March 2005)
• ICH Guidance E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (March 1995)
• ICH Guidance E9 Statistical Principles for Clinical Trials (September 1998)

CONTINUING EDUCATION (CE)

This event has been approved for 1.5 contact hours of continuing education for physicians, pharmacists, and nurses.
Please see detailed announcement for more information.
Participants may obtain a certificate of attendance which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event. For more information, see details below.

*Registration and real-time attendance via available online rooms is required.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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