REGISTRATION: https://diaglobal.zoom.us/webinar/register/WN_5f3-OCc9SUyvqeR7asDDkg
The DIA Statistics and Data Science Committee is pleased to provide further details of a webinar being held on 09 November 2021 11:00 - 12:30ET.
The Spirit of the IND Safety Reporting Final Rule webinar will feature 60 minutes of presentations followed by a 30 minute Q&A session. Registration for this exciting event is OPEN and we do hope you will be able to join us.
The format of the session and the list of speakers are described below.
• Introductions: Jonathan Haddad
• The FDA IND Safety Reporting Final Rule: Jacqueline Corrigan-Curay (FDA)
• Global Regulatory Landscape for Aggregate Safety Assessments: Greg Ball (Merck)
• A Big Pharma Solution: Mac Gordon/Amy Freedman (Janssen)
• A Smaller Company/Program Solution: Mengchun Li (TB Alliance)
• Reaction and Discussion: Bob Temple (FDA)
• Q&A
Abstract:
The FDA IND Safety Reporting Final Rule highlights the importance of aggregate analyses for determining “reasonable possibility” of a causal association with study drug for serious adverse events. In order to comply with requirements for aggregate IND safety reports and to improve the overall quality of safety reporting, sponsors need to have a proactive and systematic approach for safety evaluation based on data in the aggregate. In particular, the sponsor should periodically review program-level safety data collected across multiple studies, analyze the data in the aggregate, and make a judgment about the likelihood that the drug caused any serious adverse events. A multidisciplinary Safety Management Team should review accumulating blinded safety data from ongoing studies across a development program, in combination with review of unblinded data from completed studies and open data from other sources. A scientific evaluation of the accumulating safety data, guided by medical judgment, enables clinical as well as statistical understanding of the safety profile.
The Final Rule requires expedited reporting whenever aggregate analysis indicates events occur more frequently among patients receiving the investigational drug than in a concurrent or historic control group. The FDA’s preferred approach calls for a Safety Assessment Committee that regularly performs unblinded comparisons across treatment groups to detect numerical imbalances. An alternative approach would be to only unblind if the overall rate for a specific event is considerably higher than a predicted rate. This would require sponsors to pre-specify predicted rates of anticipated and expected events and guidelines for determining when an observed rate had exceeded the predicted rate. To meet the spirit of the Final Rule, sponsors have been developing methodologies and processes to monitor and act on accumulating safety information during development on an ongoing basis. Teams have been implementing procedures for review of aggregate blinded clinical trial data to support safety signal detection and risk-management activities, reducing the need to unblind data in ongoing studies.
The FDA and pharmaceutical industry have come together on a challenging issue. We will present a comprehensive solution and show the alignment between FDA and industry on meeting the spirit of the IND safety reporting final rule. We emphasize the importance of having a thoughtful process; a system in place to look for clinically important imbalances, applying the best clinical and quantitative judgment, while maintaining trial integrity.
REGISTRATION: https://diaglobal.zoom.us/webinar/register/WN_5f3-OCc9SUyvqeR7asDDkg
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https://diaglobal.zoom.us/webinar/register/WN_5f3-OCc9SUyvqeR7asDDkg
https://diaglobal.zoom.us/webinar/register/WN_5f3-OCc9SUyvqeR7asDDkg
https://diaglobal.zoom.us/webinar/register/WN_5f3-OCc9SUyvqeR7asDDkg