Good ReseArch for Comparative Effectiveness

The GRACE principles address good practice for the design, conduct, analysis, and reporting of observational studies of comparative effectiveness. The principles are intended to meet the needs of both those who conduct studies and those who need to evaluate the rigor of such studies to inform decision-making about therapeutic alternatives. These principles are designed in the form of questions to guide high-level evaluation; no scoring system is proposed or intended. These principles are intended as a living document that may change over time, and will be expanded to address special applications.

The ultimate goal of the principles is to enhance the quality of observational comparative effectiveness research and thus promote and facilitate the use of this research to support decision-making by patients, physicians, and payers. The principles focus on studies of pharmaceutical products, but are intended to be applicable more broadly. The GRACE principles received endorsement from the International Society for Pharmacoepidemiology and are supported by a number of professionals and organizations.

We maintain a library of case studies to illustrate how observational studies have been used to support decision-making by regulators, payers and clinical societies. We are actively seeking additional case studies. We are also seeking contributors to participate in extending the principles for special applications.

If you are interested in participating or contributing a case study, please email us.