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)

ID	Topic	Time	Presenter
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