Safety Reporting

Expert Meeting: CTTI IND Safety Advancement Project

JULY 21, 2015 TO JULY 22, 2015

CTTI Project: Safety Reporting

Meeting Objectives

  • Present findings and conclusions from the project evidence gathering activities
  • Discuss opportunities for improving the efficiency and value of the expedited IND safety reporting process
  • Understand opportunities for educating stakeholders on expedited IND safety reporting best practices

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Click here to view the presentation slides from this meeting.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Expert Meeting: IND Safety Assessment and Communication

FEBRUARY 28, 2012 TO FEBRUARY 29, 2012

CTTI Project: Safety Reporting

Meeting Background:

Since its inception, the Clinical Trials Transformation Initiative (CTTI) has had an interest in improving the quality and efficiency of safety reporting for serious adverse events (SAE) in studies performed under investigational new drug applications (INDs). CTTI’s first project on this topic focused on expedited safety reporting of serious, unexpected and possibly related SAEs to site investigators in multi-center trials. At the project’s conclusion, CTTI recommended that sponsors decrease the volume of uninterpretable and irrelevant safety reports to investigators, and instead supply investigators with meaningful reports that would improve investigators’ understanding of a drug’s benefit-risk profile. These recommendations were developed immediately prior to the FDA issuing a new final rule on safety reporting for drugs being studied under INDs.

FDA’s new IND safety reporting rule, published in the Federal Register on September 29, 2010, became effective on March 28, 2011. The intent of the new rule is to improve the quality of safety reports by minimizing the number of uninterpretable reports that sponsors submit to FDA and investigators. This is consistent with CTTI’s recommendations described above. However, CTTI members have expressed concern that there may be some uncertainty about the best methods to implement the new rule. For this reason, CTTI formed a new project entitled “IND Safety Assessment and Communication,” with the goal of promoting responsible oversight of safety for pre-market drug products consistent with the intent of the FDA’s new IND safety rule. The project objectives are as follows:

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

The project team first surveyed industry sponsors to obtain a deeper understanding of their current practices. CTTI then distributed anonymized survey results to a group of experts that included representatives from each sponsor organization that completed the survey, government (NIH, Department of Veterans’ Affairs, and FDA), academia, and patient advocacy. These experts participated in a meeting convened on February 28-29, 2012 in Bethesda, MD. A subgroup of attendees at this meeting were members of a biostatistics workgroup that the CTTI project team formed to advise on the methodological dilemmas related to implementing the new IND Safety Reporting rule.

Meeting Objectives:

  • Findings from the survey of sponsor practices
  • Companies’ strategies for implementing the new IND safety reporting rule
  • Challenges in implementing the new rule

Meeting Location:

Bethesda, Maryland

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Expert Meeting: Adverse Event Reporting

OCTOBER 03, 2010 TO OCTOBER 04, 2010

CTTI Project: Safety Reporting

Meeting Background:

The key objectives of this expert meeting included:

  • Discuss and integrate empirical findings from all components of this project
  • Consider implications of the FDA’s new safety regulations
  • Develop a set of recommendations for optimal reporting of unexpected serious adverse events to investigators that will improve human subject protection

Meeting Location:

Marriott Inn & Conference Center, Hyattsville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Day 1

Day 2

Meeting Results:

On September 29, 2010—just prior to the expert meeting—the FDA issued a new final rule and accompanying draft guidance concerning IND safety reporting. The requirements of the new safety rule, which went into effect on March 28, 2011, affected interpretation of the project findings described above. Meeting participants acknowledged that the new FDA rule marked a major step forward in recognizing that little knowledge can be gained from an individual event. Participants also agreed that inundating investigators with such data is inefficient and ineffective and that the FDA rule and guidance hold promise for helping to eliminate this burden on investigators. The discussion revealed, however, that implementation of the rule could pose challenges that may only be resolved through the concerted educational efforts and international harmonization of regulatory expectations.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Case Studies on Expedited IND Safety Reporting

CTTI Project: Safety Reporting

Webinar Presenters:

  • Annemarie Forrest, Senior Clinical Project Manager, CTTI
  • Patrick Archdeacon, Senior Clinical Advisor, Office of Medical Policy, Food and Drug Administration, Center for Drug Evaluation and Research
  • Nina Stuccio, Head, Medical Safety Review, Global Clinical Safety & Pharmacovigilance, Merck, Inc

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

Are you confused about how best to comply with the FDA final rule on IND safety reporting? Would you like to hear more about how to handle common, yet challenging, safety reporting situations? Do you know someone who is interested?

This webinar is hosted by CTTI's IND Safety Advancement Project Team and is the first in a CTTI-hosted series designed to explore challenging safety reporting scenarios using case studies.