IGNITE Pragmatic Trials Network Welcome - Ignite II

The Implementing GeNomics In pracTicE (IGNITE) Pragmatic Clinical Trials Network is an NIH-funded network dedicated to supporting the implementation of genomics in healthcare.

The Network is comprised of five research sites, a coordinating center, a steering committee, and working groups. The National Human Genome Research Institute and a data safety and monitoring board provide oversight for all network activity and are intricately involved in all aspects of IGNITE design and operation.

In order to provide evidence that genomic medicine will improve patient outcomes, IGNITE will conduct 2 – 3 large, network-wide genomic medicine pragmatic clinical trials (PCTs), which will allow for bigger, more efficient clinical trials and help researchers and clinicians understand what to expect in real-world clinical settings. These include GUARDD-US and ADOPT-PGx.

IGNITE disseminates the methods and best practices its members develop in order to advance genomic implementation in healthcare. One outlet for public distribution is the IGNITE Toolbox, which provides genomic medicine resources for clinicians and researchers. Another will be the creation of the Genomic Medicine Knowledge Base (GMKB) where ideas can be shared so that everyone can begin to use this in practice, whether in community clinics or academic medical centers.

What are Pragmatic Clinical Trials?

Pragmatic Clinical Trials are "designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens and risks of a biomedical or behavioral health intervention at the individual or population level."

Source: Califf RM, Sugarman J. 2015. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. 12:436–441. doi:10.1177/1740774515598334.