About the GRACE Initiative

GRACE Initiative Coordination
Outcome Sciences Inc (Outcome), Cambridge, MA
Nancy A. Dreyer, Initiative Leader
Priscilla Velentgas, Initiative Co-leader
April Duddy, Coordinator
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The growth in therapeutic choices for many conditions has sparked interest in evaluating the comparative effectiveness of these alternatives. Randomized clinical trials frequently do not provide direct comparisons of treatments and have limitations for certain conditions and/or population subgroups. Although the information value of non-randomized research is appreciated by many, critics often point to methodological weaknesses inherent in observational studies, coupled with the lack of standard principles to assess their quality, as practical limitations to their effective use in evidence development.

The GRACE initiative developed a core set of good practice principles to address the design, conduct, analysis, and reporting of observational studies of comparative effectiveness. In addition, a checklist to assess observational CER quality and usefulness for decision-making is under development.

The GRACE Initiative is being spearheaded by Outcome with seed funding from the National Pharmaceutical Council. GRACE contributors are from academic, government, and private sectors from around the world and represent many different perspectives on comparative effectiveness.