An insider's look into the world of pediatric drug trials: when research outcomes can quite literally represent life or death
Many parents of children with serious health problems may wonder why new medicines are initially not approved for minors and, if their condition is rare, why at the same time there is such pressure to enter any young person under 18 into drug trials. So-called 'paediatric' pharmaceutical studies have become an international multi-billion business, with many careers in academia, regulatory authorities and the pharmaceutical industry based on this work, yet much of this activity is founded on a series of flawed concepts that have led to an immeasurable waste of resources and serious, ongoing medical abuse. In this revelatory book, the former head of paediatric drug research at two major pharmaceutical companies provides a guide for parents and non-specialists interested in advancing the health of children--both individuals facing serious disease and groups of children enrolled in testing programs. Rose explains the key differences between clinically-directed and administratively-directed research, what will potentially benefit or harm children, and how laws need to change around the world so that true advances can be made.