Developing methodologies for use in observational studies of drug effects using computerised clinical data.

使用计算机化临床数据开发用于药物作用观察研究的方法。

• 批准号: G0802403/1
• 负责人: Ian Douglas
• 金额: $ 55.08万
• 依托单位: London School of Hygiene & Tropical Medicine
• 依托单位国家: 英国
• 项目类别: Fellowship
• 财政年份: 2009
• 资助国家: 英国
• 起止时间: 2009 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=G0802403%2F1
• 关键词: Developing; methodologies; use; observational; studies

The safety of medicines can be difficult to investigate and often the only possibility is to conduct observational studies to see whether people receiving a drug are more likely to experience a side effect than people who do not receive the drug. Recently more and more of these studies have been done and frequently their results have been of major public health importance (e.g. the lack of association between MMR vaccine and autism). It is important that the results of these studies are reliable, and yet their underpinning methodologies are subject to many possible biases. I plan to investigate some of these methodologies and explore their biases, with the objective of increasing the reliability of drug safety studies. This will be achieved through at least four studies using an electronic database of anonymised patient medical records. The studies will investigate possible links between SSRI antidepressants and cerebral haemorrhage, tiotropium (a treatment for chronic obstructive pulmonary disease) and stroke, ezetimibe (a lipid lowering agent) and cancer and glitazone antidiabetics and myocardial infarction. This programme of research will therefore answer questions directly related to the safety of four drugs/drug classes and will improve methodological approaches to drug safety studies in the future.

药物的安全可能很难进行调查，通常唯一的可能性是进行观察性研究，以了解接受药物的人是否比未接受该药物的人更有可能经历副作用。最近，越来越多的研究已经完成，并且它们的结果经常具有很大的公共健康重要性（例如，MMR疫苗与自闭症之间缺乏关联）。重要的是，这些研究的结果是可靠的，但是它们的基础方法却有许多可能的偏见。我计划研究其中一些方法并探索它们的偏见，目的是提高药物安全研究的可靠性。这将通过至少四个研究使用匿名患者病历的电子数据库来实现。这些研究将研究SSRI抗抑郁药与脑出血，tiotiotium（用于慢性阻塞性肺疾病的治疗）和中风，ezetimibe（一种脂质降低剂），癌症和glitazone抗糖尿病和心肌梗塞。因此，该研究计划将回答与四个药物/药物类别的安全性直接相关的问题，并将改善未来药物安全研究的方法学方法。