ClinicalTrials.gov and FDAAA for NIH Grantees. NIH Regional Seminar - June 2013 Rebecca J. Williams, PharmD , MPH Assistant Director, ClinicalTrials.gov National Library of Medicine. http://ClinicalTrials.gov. Overview.
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NIH Regional Seminar - June 2013
Rebecca J. Williams, PharmD, MPH
Assistant Director, ClinicalTrials.gov
National Library of Medicine
Kaplan-Meier estimates for ulcer complications according to traditional definition. Results are truncated after 12 months, no ulcer complications occurred after this period. Adapted from Lu 2001.
Source: Jüni P, Rutjes AW, Dieppe PA. BMJ. 2002 Jun 1;324(7349):1287-8.
BMJ 2011;344:d7292 doi
Zarin DA, Tse T. Science. 2008
FDAAA = Food and Drug Administration Amendments Act of 2007
The responsible party for an applicable clinical trial (ACT) subject to FDAAA must :
*International Committee of Medical Journal Editors (ICMJE) requires registration prior to enrollment of first participant as a condition of consideration for publication
* ClinicalTrials.gov Protocol Data Element Definitions (DRAFT): http://prsinfo.clinicaltrials.gov/definitions.html
* Laine C, Horton R, DeAngelis C, et al. Ann Intern Med. 2007; http://www.icmje.org/faq_clinical.html
“Default” Required Measures
PI and Clinical Research Team
Other Medical Researchers in same field
Other Medical Researchers in other fields
Other Readers of the medical literature
Lay Public (readers of consumer health literature)
Food and Drug Administration Amendments Act of 2007
Announcement in Department’s Unified Agenda of Regulatory Action
Agency Develops Draft Notice of Proposed Rulemaking (NPRM)
Department and OMB Review
NPRM Published in Federal Register
Public Comment Period (typically 60 – 90 days)
Agency Responds to Comments/ Develops Final Rule
Department and OMB Review
Final Rule Published in Federal Register
Available at: http://prsinfo.clinicaltrials.gov/index.html
Eight presentations with audio and slides
5. Participant Flow Module
6. Baseline Characteristics Module
7. Outcome Measures and Statistical Analysis Module
8. Adverse Events Module
Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database – update and key issues. N Engl J Med 2011;852-860.
Tse T, Williams RJ, Zarin DA. Update on registration of clinical trials in ClinicalTrials.gov. Chest 2009;136:304-5.
Tse T, Williams RJ, Zarin DA. Reporting basic results in ClinicalTrials.gov. Chest 2009;136:295-303.
Zarin DA, Tse T. Moving toward transparency of clinical trials. Science 2008;319:1340-2.