Personalised Medicine and a Data Revolution: Hope and Peril

This chapter examines the challenges posed by technological breakthroughs, including the complexity of data, and in particular the role to be given to consent that would provide transparency and foster patients’ trust in the development of personalized medicine. Personalized medicine is one of the most promising approaches to tackling diseases that have thus far eluded effective treatments or cures. “Personalised medicine fundamentally relies on the successful digitisation of patient records, other healthcare data sets, and increasingly ‘citizen-generated’ health-related data”. Without a regulatory framework and guidance on how best to design a successful clinical trial for personalized therapy, personalized medicine developers risk presenting suboptimal evidence about stratification options. Widespread data sharing will radically accelerate personalized medicine, making discovery and treatment more efficient. Transparency about data practices is essential not just as a fundamental element of privacy, but it is also a key to engendering trust, which in turn is critical to the adoption of personalized medicine.