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How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions.
Hendrickson, Barbara A; McShea, Cynthia; Ball, Greg; Talbot, Susan.
Afiliación
  • Hendrickson BA; Department of Pediatrics, University of Chicago, Chicago, IL, 60637, USA. bhendric@bsd.uchicago.edu.
  • McShea C; Biometrics and Quantitative Sciences, UCB Biosciences, Inc., Morrisville, NC, USA.
  • Ball G; ASAP Process Consulting, Manalapan, NJ, USA.
  • Talbot S; Amgen Inc., Thousand Oaks, CA, 91320, USA.
Ther Innov Regul Sci ; 58(4): 579-590, 2024 Jul.
Article en En | MEDLINE | ID: mdl-38555342
ABSTRACT
In June 2021, FDA released a Draft Guidance on Sponsor Responsibilities for IND Safety Reporting and cited components of a recommended Safety Surveillance Plan (SSP).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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Drogas en Investigación Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Ther Innov Regul Sci Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Drogas en Investigación Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Ther Innov Regul Sci Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza