Personalised and precision medicine (PPM) has the potential to revolutionise not only the treatment but also the prevention of diseases. Advances such as the successful development of targeted therapies like imatinib mesylate for chronic myeloid leukaemia and Herceptin/trastuzumab for erbB-2-positive breast cancer have changed clinical practice for these cancer indications. However, for every breakthrough therapy, there is a succession of ‘one-size-fits-all’ approaches that deliver minimal or no benefit despite the billions of euros/dollars and the number of years invested in their development. There are various challenges now to facilitate an accelerated ‘concept-to-clinic’ culture, but in a way that translates preliminary discovery ‘hits’ into robust but affordable clinical ‘wins’ for patients. In this special issue of Public Health Genomics, several stakeholders outline the key challenges and the potential solutions that will help embed PPM in evolving innovative clinical trial frameworks. These have been brought together by the Brussels-based European Alliance for Personalised Medicine, a multi-stakeholder organisation that includes patient groups, researchers, front-line healthcare professionals, industry representatives and more, and is in regular discussions with the European Council, Commission, Parliament and Member State governments as it aims to see PPM integrated into healthcare systems across the EU.weiterlesen