Vaccine Database Initiative

Vaccine Database InitiativeThis project tracks the conversion of vaccine legacy clinical trial data into a standardized format and stores it in a newly created database so that OBE staff and other CBER staff can evaluate new approaches to analysis of safety and efficacy across studies.TBD

COMPLETED

ON TRACK

A. Phase 1: Confirm reproducibility for all studies

6/30/2011

Completed

6/28/2011

B. Phase 2: Evaluate and determine which datasets can be pooled and create a new, larger dataset

9/30/2011

Completed

9/30/2011

C. Phase 3: Launch new exploratory studies on autoimmune conditions and detecting unexpected and rare adverse events

12/30/2011

Completed

12/19/2011

D. Phase 4: Perform subgroup analysis by gender on combined data.

1/31/2012

Completed

1/31/2012

E. Assess how combining data from multiple studies can contribute to improved public health outcomes

3/30/2012

Completed

5/30/2012

Molecular EpidemiologyMolecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.

http://www.fda.gov/AboutFDA/Transparency/track/ucm206350.htmFDA-TRACK CBER Cross Program Support Offices Dashboard