The FDA’s Sentinel Initiative is developing a program for rapid application of sophisticated epidemiologic methods in the evaluation of medical products. The Prospective Routine Observational Monitoring Program Tools (PROMPT) provides semi-automated routine surveillance by applying general tools with minor adaptations to address a specific product. This request is for investigators to propose and carry out evaluations of PROMPT in the IMEDS Lab using drugs and outcomes for which there strongly believed to be no causal association, but for which there is a reasonable possibility of the existence of one of the biases that are known to threaten observational cohort studies of drugs and outcomes in settings where data are collected only passively.
Award Amount: $100,000
Proposal Release Date: April 10, 2015
Proposal Deadline: Friday, June 10, 2015 at 4:30 p.m. ET
PROMPT Assessment (RUF-IMEDS-FP_0004) Request for Proposal
Please submit your proposal by email to the attention of Susan Gruber at IMEDS@reaganudall.org.