Background

The FDA’s recent change in regulation on reporting of serious, unexpected, suspected adverse reactions calls for IND sponsors to evaluate the data collected across all studies in an IND. Many sponsors have long had such internal monitoring committees, but their composition and practices have been described minimally. Before one considers recommendations for future approaches that will support the intent of the new FDA rule on IND safety reporting, it is critical to understand past practices. The IND Safety Assessment and Communication Project seeks a deeper understanding of current program-level, pre-marketing practices related to potential safety signals. This will facilitate the identification of issues and the formulation of recommendations.

 

Goal

Promote responsible oversight of safety for pre-market products consistent with the intent of the FDA’s new IND safety rule.

 

Objectives

1. To obtain a deeper understanding of sponsors’ current practices:
   • for assessing safety of a pre-market product across all trials and sources of safety information
   • for communicating potential safety signals
2. To facilitate an informed discussion of practices and challenges in assessing and communicating IND safety information
3. To issue recommendations for future approaches that will support the intent of the IND safety reporting rule effective March 2011

 

Methods

The methods for this project comprise four steps:

1. Collect sponsors’ descriptions of their organization’s program-level, pre-market practices for assessing safety.
2. Conduct a workshop to share sponsors’ insights and concerns related to IND safety assessments. Relevant experts will participate in the discussion.
3. Convene a biostatistics workgroup to discuss methodological issues. Issues to be addressed include a) frequency and methods of aggregate analyses to determine if observed serious adverse events common in a study population or known consequences of an underlying disease are occurring more frequently in the drug treatment group than in the control group; b) thresholds for reporting serious adverse events as suspected adverse reactions; and c) assessment of premarket safety information across multiple studies and sources of safety information.
4. Summarize current practices, issues, and recommendations.

 

Team Organization

 

Funding and Other Support

Financial support is being provided by Grant # U19 FD003800 from the U.S. Food and Drug Administration (FDA). Volunteer time and donated resources are provided by Amgen Inc., Bristol-Myers Squibb, and FDA.

 

Contact Information

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