Centre for Drug Safety Science (CDSS)

药物作为药物的使用为人类健康作出了巨大贡献，药物发现过程涉及到人类疾病的大多数方面。然而，所有药物都与副作用或药物不良反应(ADR)有关，这些副作用和不良反应的频率和严重程度取决于药物和患者群体。NHS和医疗行业的总体负担都很大。我们已经表明，在所有成人住院中，至少6.5%是由ADR引起的，大约15%的住院患者在住院期间遭受ADR。在全国范围内推算，英国NHS每年花费的ADR费用超过6.37亿GB，或每年每张医院床位约5000 GB。这是一个保守的估计，很可能要高得多。我们在英国的发现已经在许多国家重复，表明ADR是一个全球性的健康问题。ADR可以导致停药或限制使用药物，即使ADR只发生在少数患者身上。这可能会阻碍医生为大多数患者开出其他有效的药物，这些患者从药物中受益，而不会出现不良反应。药物安全的整个问题也对制药业的盈利能力有重大影响，从而对英国经济也有重大影响。MRC药物安全科学中心(CDSS)因此于2008年成立，作为利物浦大学(UOL)和曼彻斯特大学(UOM)之间的合作，以回应人们认为需要建立一个国家中心来调查ADR的机制。CDSS中已经创建了一个基础设施，允许临床前和临床科学家使用尖端技术并肩工作，分析定义明确的临床样本。我们对药物性肝损伤和药物性超敏反应机制的认识已经取得了进展，包括对遗传易感因素的识别和改进的诊断试验。在接下来的5年里，我们的创新发现将转化为更好的患者临床护理，改善制药行业的药物开发，并为监管机构提供更好的信息。此外，我们的基础设施将扩展到评估与肾脏、胃肠道和心血管系统相关的药物副作用。总体而言，CDSS及其合作者的发现将提供对ADR风险的更好了解，并改善患者的预后。我们将继续以非竞争的方式与制药行业和监管机构的科学家密切合作，使我们能够获得公司特定的药物和患者样本，这为我们提供了应对全行业药物安全挑战的工具。与此同时，我们将作为一个论坛，与所有药物安全科学专业人员(无论是学术界、医疗保健提供者、行业或监管机构)进行培训和知识交流，并通过扩大针对非临床和临床科学家的培训计划，大大加强这些专业人员的知识交流。这将使我们能够提高英国所有相关利益相关者的药物安全科学能力。我们将继续在所有层面开展患者和公众参与活动，以确保我们的目标和目标得到改进，使患者成为该中心研究和培训活动的中心焦点。因此，该中心的新使命声明是“利用我们在该中心积累的关键质量和药物安全科学知识，从事前沿科学，并培训下一代药物安全科学家，了解临床上重要和当前相关的不良药物反应的基本机制，以便制定战略，提高现有药物和新药的效益-风险比，造福患者、行业和监管机构。”

The use of drugs as medicines has made an enormous contribution to human health with the drug discovery process being directed to most aspects of human disease. However, all drugs are associated with side effects or adverse drug reactions (ADRs) which vary in frequency and severity dependent on the drug and patient population. The overall burden is large to both the NHS and Industry.We have shown that at least 6.5% of all adult admissions to hospitals are due to ADRs and that approximately 15% of inpatients suffer an ADR during hospitalisation. Extrapolated nationally, ADRs are thought to cost the NHS in England in excess of £637 million annually, or approximately £5000 per hospital bed per year. This is a conservative estimate and is likely to be much higher. Our findings in the UK have been replicated in many countries showing that ADRs are a global health issue.ADRs can lead to withdrawal or restricted use of drugs, even if the ADR occurs in only a minority of patients. This can impede the use of otherwise effective drugs being prescribed by physicians for the majority of patients who benefit from the drug without developing ADRs. The whole issue of drug safety also has a major impact on the profitability of the pharmaceutical industry, and thus the economy of the UK.The MRC Centre for Drug Safety Science (CDSS) was therefore created in 2008 as a collaboration between the Universities of Liverpool (UoL) and Manchester (UoM) in response to a perceived need to establish a National Centre to investigate mechanisms of ADRs. An infrastructure that allows pre-clinical and clinical scientists to work side-by-side using cutting-edge technologies to analyse well-defined clinical samples has been created in CDSS. Progress has been made in our understanding of the mechanisms of drug-induced liver injury and drug-induced hypersensitivity, including the identification of genetic predisposing factors and the development of improved diagnostic tests. Over the next 5 years our innovative findings will be translated into better clinical care for patients, improved drug development for Pharmaceutical Industry and better information for Regulators. Furthermore, our infrastructure will be extended to evaluate drug side effects associated with the kidney, the gastrointestinal tract and the cardiovascular system. Collectively, the findings from the CDSS and its collaborators will provide a better understanding of risk of ADRs and improve patient outcomes. We will continue to work closely with scientists from the pharmaceutical industry and from regulatory authorities in a non-competitive manner that will allow us to access company-specific drugs and patient samples which provide us with the tools to address industry-wide drug safety challenges. At the same time we will act as a forum for training and knowledge exchange with all drug safety science professionals (be they in academia, health care providers, industry or regulatory authorities) which will be significantly enhanced by our expanded training programme for non-clinical and clinical scientists. This will allow us to improve capacity in drug safety science in the UK for all relevant stakeholders. We will continue our patient and public engagement activities at all levels in order to ensure that our aims and objectives are refined to make patients a central focus of the research and training activities in the Centre.Thus the new mission statement for the Centre is "to use the critical mass and knowledge in drug safety science that we have now accrued within the Centre to undertake leading edge science, and train the next generation of drug safety scientists, to understand the fundamental mechanisms of clinically important and currently relevant adverse drug reactions in order to develop strategies to improve the benefit-risk ratio of current and new medicines, for the benefit of patients, industry and regulators."