Propelling Health Care into the Twenties.

The scope and potential of personalised health care are underappreciated and underrealised, often because of resistance to change. The consequence is that many inadequacies of health care in Europe persist unnecessarily, and many opportunities for improvement are neglected. This article identifies the principal challenges, outlines possible approaches to resolving them, and highlights the benefits that could result from greater adoption of personalised health care. It locates the discussion in the context of European policy, focusing particularly on the most recent and authoritative reviews of health care in the EU Member States, and on the newly acquired spirit of readiness and pragmatism among European officials to embrace change and innovative technologies in a new decade. It highlights the attention now being given by policymakers to incentives, innovation, and investment as levers to improve European citizens' prospects in a rapidly evolving world, and how these distinct and disruptive themes contribute to a renaissance in thinking about delivering optimal health care in Europe. It explores the chances offered to patients by specific initiatives in health domains such as cancer and antimicrobial resistance, and by innovative science, novel therapies, earlier diagnosis tools, and deeper understanding of health promotion and prevention. And it reflects on how health care providers could benefit from a shift towards better primary care and towards deploying health data more effectively, including the use of artificial intelligence, coupled with a move to a smoother organisational/regulatory structure and realigned professional responsibilities. The conclusion is that preparing Europe's health care systems for the inevitable strains of the coming years is both possible and necessary. A more courageous approach to embracing personalised health care could guarantee the sustainability of Europe's health care systems before rising demands and exponential costs overwhelm them - an exercise in future-proofing, in ensuring that they are equipped to withstand whatever lies ahead. A focus on the potential and implementation of personalised care would permit more efficient use of resources and deliver better quality health-preserving care.

Integrating Personalized Medicine in the Canadian Environment: Efforts Facilitating Oncology Clinical Research.

There is currently a rapid evolution of clinical practices based on the introduction of patient stratification and molecular diagnosis that is likely to improve health outcomes. Building on a strong research base, complemented by strong support from clinicians and health authorities, the oncology field is at the forefront of this evolution. Yet, clinical research is still facing many challenges that need to be addressed in order to conduct necessary studies and effectively translate medical breakthroughs based on personalized medicine into standards of care. Leveraging its universal health care system and on resources developed to support oncology clinical research, Canada is well positioned to join the international efforts deployed to address these challenges. Available resources include a broad range of structures and funding mechanisms, ranging from direct clinical trial support to post-marketing surveillance. Here, we propose a clinical model for the introduction of innovation for precision medicine in oncology that starts with patients' and clinicians' unmet needs to initiate a cycle of discovery, validation, translation and sustainability development.

Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine.

Scientific knowledge and our understanding of the human body and diseases have limited any possible treatment tailoring to each patient. The technological advances enabling the integration of various data sets (e.g. '-omics', microbiome, epigenetics and environmental exposure) have facilitated a greater understanding of the human body, the molecular basis of disease and all the factors influencing disease onset, progression and response to treatment, thereby ushering in the era of personalized medicine. We evaluate the regulatory approaches available to facilitate early patient access to efficacious and safe compounds in the EU and the USA in order to make more informed recommendations in the future as to the gaps in regulations for early patient access. An in-depth analysis of conditional approvals (EU) and accelerated approvals (USA) is performed based on the publicly available information (European public assessment reports and a summary review of products approved under both programmes). The types of product, indications, time to approval and type of evidence submitted were analysed. Between 2007 and early 2015, 17 products were conditionally approved in the EU and 25 in the USA, most of them in the area of oncology and based on evidence from phase II clinical trial data. Early approval of promising products based on data from early phases of development is already possible in the EU and the USA. Some of the improvements could entail implementing a rolling assessment of evidence in Europe and extending the scope of early dialogues.

Burden of acute gastroenteritis among children younger than 5 years of age--a survey among parents in the United Arab Emirates.

BACKGROUND: Despite its high incidence among children under the age of five, little is known about the burden of pediatric gastroenteritis outside the medical setting. The objective of this study was to describe the burden of acute gastroenteritis among children residing in the United Arab Emirates, including those not receiving medical care. METHODS: A quantitative cross-sectional survey of 500 parents of children under 5 years of age who had suffered from acute gastroenteritis the preceding three months was conducted in the cities of Abu Dhabi and Al Ain. Data collected included respondent characteristics, disease symptoms, medical care sought, and parental expenditures and work loss. Data were analyzed using parametric and non-parametric statistical methods. RESULTS: Vomiting and diarrhea episodes lasted on average between 3 and 4 days. Overall, 87% of parents sought medical care for their children; 10% of these cases required hospitalization with an average length of stay of 2.6 days. When medical care was sought, the average parental cost per gastroenteritis episode was US$64, 4.5 times higher than with home care only (US$14). Nearly 60% of this difference was attributable to co-payments and medication use: 69% of children used oral rehydration solution, 68% antiemetics, 65% antibiotics and 64% antidiarrheals. Overall, 38 parents missed work per 100 gastroenteritis episodes for an average of 1.4 days. CONCLUSIONS: Given its high incidence, pediatric gastroenteritis has an important financial and productivity impact on parents in the United Arab Emirates. To reduce this impact, efforts should be made both to prevent acute gastroenteritis and to optimize its treatment.