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NLM BOARD OF REGENTS WORKING GROUP ON CLINICAL TRIALS

Meeting #1

February 11, 2008
9:00 a.m. – 3:00 p.m.

Board of Regents Room
National Library of Medicine (Bldg. 38, Mezzanine Level)

Agenda

IDTopicTimePresenter
1. WELCOME AND INTRODUCTORY REMARKS 9:00 – 9:10 Dr. Lindberg
2. CALL TO ORDER AND INTRODUCTION OF MEMBERS 9:10 – 9:20 Dr. Morton
3. REVIEW OF AGENDA 9:20 – 9:25 Dr. Morton
4. BACKGROUND AND LEGISLATIVE REQUIREMENTS 9:25 – 10:15  
 
  • What is ClinicalTrials.gov, and how has it evolved over time
  Dr. Zarin
 
  • Why have clinical trial databases become an issue for policy attention?
   
 
  • What policies affect trial registration and results reporting
  Mr. Sheehan
 
  • What does the new law (Public Law 110-85) require?
   
 
  • What resources are available for implementing the new requirements?
  Mr. Danielson
  DISCUSSION 10:15 – 10:30  
  BREAK 10:30 – 10:45  
5. EXPANDED CLINICAL TRIALS REGISTRY
  • What does Public Law 110-85 require for registration?
  • What has NLM accomplished to-date?
  • How has the affected community responded?
  • What are some open issues?
10:45 – 11:20 Dr. Zarin
  DISCUSSION 11:20 – 12:00  
  LUNCH 12:00 – 1:00  
6. RESULTS REPORTING 1:00 – 1:45  
 
  • What does Public Law 110-85 require for results reporting
  Dr. Zarin
 
  • What has NLM done?
   
 
  • What is NLM planning to develop for results reporting?
  Dr. McDonald
  DISCUSSION 1:45 – 2:30  
7. ADVERSE EVENT REPORTING
  • What does Public law 110-85 require for Adverse Events reporting?
  • What options is NLM considering?
2:30 – 2:45 Dr. Zarin
  DISCUSSION 2:45 – 2:55  
8. SUMMARY AND NEXT STEPS 2:55 – 3:00 Dr. Morton
  ADJOURNMENT 3:00