The DIA Statistics and Data Science Community is pleased to provide further details of a webinar being held on 18 November 2021 11:00-12:30 ET.
The Aggregate Safety Assessment Planning (ASAP) Process webinar will see 45 minutes of presentations covering both the clinical and statistical experts followed by a 45 minute panel session. Registration for this excitingRegistration for this exciting webinar is OPEN and further details on the format and the abstract are provided below. We do hope you will be able to join us for what promises to be an interesting session.
Introductions: Jonathan Haddad
Clinical Perspective: Barbara Hendrickson (AbbVie)
Statistical Perspective: Cindy McShea (UCB)
Panel Session: Greg Ball (Merck), Brenda Crowe (Lilly), Barbara Hendrickson (AbbVie), Mengchun Li (TB Alliance), Cindy McShea (UCB), Estelle Russek-Cohen (ERCStatLLC), Lothar Tremmel (CSL Behring)
In 2009, the Program Safety Analysis Plan (PSAP) was proposed as a tool to proactively plan for analyses of product safety data. Building on the PSAP and taking into consideration the evolving regulatory landscape, the Drug Information Association–American Statistical Association (DIA-ASA) Interdisciplinary Safety Evaluation (DAISE) scientific working group recently has proposed an Aggregate Safety Assessment Planning (ASAP) process (Hendrickson et al. 2021).
Components of the ASAP can assist in addressing the new FDA draft guidance, Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessments for IND and Bioavailability/Bioequivalence Studies (June 2021 ), which replaces a prior guidance from 2015 and 2012. This new guidance discusses a sponsor’s responsibility to assess if reported clinical trial serious adverse events are unexpected per the product reference safety information and have a “reasonable possibility” of a causal association with study drug. The sponsor assessment of causality for serious events from ongoing blinded studies presents significant challenges for the industry, particularly for events which may occur in the patient population regardless of study drug administration (anticipated serious adverse events). The FDA guideline recommends aggregate analyses of anticipated serious adverse events looking for higher rates in the test treatment arm versus the control arm. To reduce risk of frequent unblinding, sponsors can apply methodology to compare background rates for the population to observed blinded rates in the ongoing blinded studies. If the blinded overall rate is significantly higher than the background rate, unblinding would be triggered to assess if an IND Safety report is required.
The ASAP Process provides a framework for sponsors to implement the “trigger” approach through prompting multi-disciplinary safety management teams to proactively plan for aggregate assessment of the safety data. The information needed to implement the trigger approach is captured in the ASAP template and Safety Surveillance Plan (examples of both are contained in supplemental material to the published ASAP paper).
In this webinar authors of the ASAP paper will present an overview of the ASAP process and describe how the framework can be employed by companies of all sizes to implement the aggregate analyses described in the IND Safety Reporting guideline. Attendees will gain perspectives on the process and discuss potential hurdles for implementation.