IMEDS Methods

IMEDS-Methods Program

IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA’s scientific mission of serving public health needs through research into methods for safety evaluation. IMEDS-Methods aims to improve the tools for post-marketing safety surveillance using automated healthcare data and to foster their adoption. IMEDS-Methods also adds to the general body of knowledge about the use of such data for generating evidence about marketed regulated products.

IMEDS-Methods Research Agenda

The IMEDS-Methods Research Agenda is updated annually through an iterative process that integrates knowledge and priorities solicited from the FDA, the IMEDS Scientific Advisory Committee (SAC) and Steering Committee (SC), commercial and academic stakeholders, and the public. The updated research agenda for 2015 was formulated to build on the successes achieved during 2014, and to reflect the goals and priorities articulated by stakeholder groups.

The 2015 IMEDS-Methods Research Agenda can be found here.

The 2014 IMEDS-Methods Research Agenda can be found here.

IMEDS-Methods Scientific Achievements

The IMEDS-Methods Scientific Achievements reports summarize the performance and key achievements of the IMEDS-Methods Program, and provide a detailed look at our yearly activities.

To download a copy of these annual reports, please click on each of the links below:

2014 IMEDS-Methods Scientific Achievements

2015 IMEDS-Methods Scientific Achievements


IMEDS-Methods Request for Proposals

The Reagan-Udall Foundation issued 2015 Request for Proposals (RFPs) to accomplish projects on the IMEDS-Methods research agenda.

Funded 2015 RFPs:

PROMPT Assessment RFP (RUF-IMEDS-FP_0004): 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. The project is currently led by Dr. Michele-Jonsson-Funk, PhD, from Gilliongs School of Global Public Health at the University of North Carolina.

Center of Excellence for Monitoring Research on Bias in Research using Electronic Health Data RFP (RUF-IMEDS-FP_0003): IMEDS proposes to enter into collaboration with an academic center that could serve as a Center of Excellence for annually collating and summarizing research at the intersection of data analysis and medical data generation, particularly as these pertain to the evaluation of safety and effectiveness of medical products.

College of Pharmacy at the University of Illinois - Chicago has been awarded to establish the Center for Annotating Research Methods and Analyses (CARMA), led by Dr. Todd Lee, PharmD., PhD. To learn more about CARMA and what it can do for you, check out our July IMEDS Community Call Series.

To download a description of the RFP Preview Process, click here

Inquiries

Please direct all inquiries to:

Christine Yu, IMEDS Program Coordinator
Reagan-Udall Foundation for the FDA
Email: IMEDS@reaganudall.org