临床试验注册.pptxVIP

　　临床试验注册.什么是临床试验？.临床试验：所有以人体为研究对象的药物、生物制剂、设备和器械、手术、行为干预等的干预性研究Reasons for Conducting Clinical Studies.In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or conditionFinding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or conditionExamining methods for identifying a condition or the risk factors for that conditionExploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illnessThe rise in non-systematic reviews，case reports，trials，and systematic reviews，1950 to 2007 (as identified in MEDLINE).Bastian H，Glasziou P，Chalmers I (2010) Seventy-Five Trials and Eleven Systematic Reviews a Day: How Will We Ever Keep Up?. PLoS Med 7(9): e1000326. doi:10.1371/journal.pmed.1000326/article/info:doi/10.1371/journal.pmed.1000326/article/info:doi/10.1371/journal.pmed.1000326.临床试验面临的问题...EQUATOREnhancing the QUAlity and Transparency Of health Research医学研究报告规范出口把关ICTRPInternational Clinical Trials Registry Platform临床试验注册入口把关.临床试验透明化.什么是临床试验注册？.临床试验注册是指将临床试验的设计、实施、监管和研究结果的相关信息在国际认可的注册机构中公开，任何人均可免费获取卫生研究的相关信息，实现卫生研究设计、实施过程和结果的透明化，并可溯源。Trial Registry PurposesRegistry PurposeGroup That BenefitsFulfill ethical obligations to participants and the research communityPatients, the general public, the research communityProvide information to potential participants and referring cliniciansPatients, cliniciansReduce publication biasUsers of the medical literatureHelp editors and others understand the context of study res