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Meeting Background

The purpose of this meeting, hosted by CTTI, is to facilitate a broad scientific discussion about optimal ways to generate additional evidence to help inform the safe and effective use of extended-release and long-acting opioid analgesics.

Meeting Objectives

• Engage multiple stakeholders in discussions around approaches to develop more evidence on the long-term safety and efficacy of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain
• Review and discuss a proposed study to evaluate the long-term efficacy of opioids for the treatment of chronic non-cancer pain
• Discuss strategies to assess the long-term safety of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain

Meeting Presentations*

• Welcoming Remarks by Pamela Tenaerts and Rachel Sherman

Session 1: Evidence for the Efficacy of Opioid Analgesics for Chronic Pain

• Review of the Evidence for the Efficacy and Effectiveness of Opioid Analgesics for Chronic Pain by Jane Ballantyne

Session 2: Review of Proposed Efficacy Study

• Overview of Efficacy Protocol Synopsis by Robert Califf
• Proposed Protocol Synopsis (PDF)

Session 3: Continued Discussion of Efficacy Study

Session 4: Existing Data Sources to Evaluate Opioid Analgesic Safety

• Monitoring Opioid Analgesic Abuse and Overdose in the United States by Christopher M. Jones
• Postmarketing Surveillance of Prescription Drug Abuse by Richard Dart
• Harnessing National Data Sets: National Survey on Drug Use and Health (NSDUH) and VA Data by William Becker
• Using Integrated Health Plan EMR Data to Evaluate Outcomes Associated with Clinical Services for the Treatment of Non-Malignant Chronic Pain by Lynn DeBar

Session 5: Gathering Additional Evidence on Opioid Analgesic Safety

*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.