Introduction

This introduction presents an overview of key concepts discussed in the subsequent chapters of this book. The book discusses that the FDA final guidance on Patient Reported Outcome (PRO) measures has just been published, three years since the draft guidance appeared in 2006. It discusses Allen Ganser, Steven Raymond and Jay Pearson, who present previously unpublished study data comparing the quality and power of PRO data collected electronically and with paper. The book also discusses Bill Byrom, Keith Wenzel and James Pierce review data on instruments designed to replace or compliment subjective clinician assessed scales, such as those used in CNS studies. It provides a valuable and comprehensive reference for the statistical methodology appropriate to demonstrating equivalence between paper and electronic PRO modalities when migrating existing diaries from original paper versions. The book discusses Breffni Martin considers this with an example of a mobile phone solution developed for disease management of patients suffering from obesity.