How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions

In June 2021, FDA released a Draft Guidance on Sponsor Responsibilities for IND Safety Reporting and cited components of a recommended Safety Surveillance Plan (SSP). To meet the expectations of the 2021 FDA guidance, sponsors should document their plan for aggregate safety assessment. The Drug Info...

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Bibliographic Details
Published in:Therapeutic innovation & regulatory science 2024-07, Vol.58 (4), p.579-590
Main Authors: Hendrickson, Barbara A., McShea, Cynthia, Ball, Greg, Talbot, Susan
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems - standards
Analytical Report
Decisions
Drug Safety and Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Drugs, Investigational
Humans
Medicine
Monitoring
Pharmacotherapy
Pharmacovigilance
Pharmacy
Safety
United States
United States Food and Drug Administration
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Summary:In June 2021, FDA released a Draft Guidance on Sponsor Responsibilities for IND Safety Reporting and cited components of a recommended Safety Surveillance Plan (SSP). To meet the expectations of the 2021 FDA guidance, sponsors should document their plan for aggregate safety assessment. The Drug Information Association-American Statistical Association Interdisciplinary Safety Evaluation scientific working group has proposed an Aggregate Safety Assessment Plan (ASAP) that addresses this recommendation. The 2021 FDA guidance also discusses potential strategies for unblinded review of safety data from ongoing studies by an independent Assessment Entity, which could occur via planned periodic evaluations or “triggered” reviews based on blinded data assessments. The Assessment Entity reviewing unblinded data makes recommendations as to whether the threshold has been met for submission of an aggregate IND safety report. In this paper, we discuss how the ASAP supports IND aggregate safety reporting decisions, including elements to be included in a proposed SSP appendix to the ASAP. In addition, the authors advocate for the benefits of developing a charter (or specific section of the Data Monitoring Committee charter, if applicable) that describes the responsibilities and conduct of the Assessment Entity. With these components in place, study sponsors will meet the objective of having clearly defined processes for the monitoring of clinical trial safety data in aggregate and making IND safety reporting decisions.
ISSN:2168-4790
2168-4804
2168-4804
DOI:10.1007/s43441-024-00634-5