Can We Identify Patients at High Risk of Harm under a Generally Safe Intervention?
Gerd K Rosenkranz · International Journal of Clinical Biostatistics and Biometrics · 2017
Personalized medicine today is primarily addressing efficacy. Here we investigate and illustrate the role that precision medicine could play in drug safety by supporting the identification of subjects at high risk of harm by an otherwise safe and efficacious treatment. Predicting potential harm requires high sensitivity of a classification rule. After reviewing some case studies from the literature we discuss the appropriateness of two methods to identify sub- groups of patients at risk.