Incorporation of Pharmacogenomics into Routine Clinical Practice: the Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline Development Process

Kelly E. Caudle, Teri E. Klein, James M. Hoffman, Daniel J. Müller, Michelle Whirl-Carrillo, Li Gong, Ellen M. McDonagh, Katrin Sangkuhl, Caroline F. Thorn, Matthias Schwab, José A.G. Agúndez, Robert R. Freimuth, Vojtech Huser, Ming Ta Michael Lee, Otito F. Iwuchukwu, Kristine R. Crews, Stuart A. Scott, Mia Wadelius, Jesse J. Swen, Rachel F. Tyndale, C. Michael Stein, Dan Roden, Mary V. Relling, Marc S. Williams, Samuel G. Johnson

The Clinical Pharmacogenetics Implementation Consortium (CPIC) publishes genotype-based drug guidelines to help clinicians understand how available genetic test results could be used to optimize drug therapy. CPIC has focused initially on well-known examples of pharmacogenomic associations that have been implemented in selected clinical settings, publishing nine to date. Each CPIC guideline adheres to a standardized format and includes a standard system for grading levels of evidence linking genotypes to phenotypes and assigning a level of strength to each prescribing recommendation. CPIC guidelines contain the necessary information to help clinicians translate patient-specific diplotypes for each gene into clinical phenotypes or drug dosing groups. This paper reviews the development process of the CPIC guidelines and compares this process to the Institute of Medicine's Standards for Developing Trustworthy Clinical Practice Guidelines.