Ethics

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data

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CTTI Project: Electronic Healthcare Data

Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib), the first trial to use the U.S. Food and Drug Administration’s (FDA) FDA-Catalyst System network of electronic health data from a diverse group of national health plan data partners.

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CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

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CTTI Project: Single IRB

The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.

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Use of Central IRBs for Multi-center Clinical Trials

APRIL 25, 2012 TO APRIL 26, 2012

CTTI Project: Single IRB

Meeting Background:

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multi-center trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections recommending this approach. The goal of the CTTI project is to identify potential solutions to address barriers to the adoption of central IRBs for multi-center clinical trials.

Meeting Objectives:

  • Present research findings from the CTTI project entitled, Use of Central IRBs for Multi-center Clinical Trials
  • Discuss research findings among experts present at the meeting
  • Solicit additional feedback to refine proposed solutions

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

*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: 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.

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.