医疗机构药物临床试验成本测算方法探讨
[摘要] 随着国家和社会对新药研发投入力度的不断增加，医疗机构接受药物临床试验的数量逐渐增多。很多医疗机构药物临床试验工作未开展成本核算，难以提供临床试验的精确成本情况。医疗机构签署研究协议时，常常被动接受申办方提供的预算。医疗机构对药物临床试验机构建设投入，难以通过开展药物临床试验业务回收成本。在一定程度上影响了医疗机构对临床试验工作的投入积极性。该文探讨测算医疗机构开展药物临床试验的成本，为药物临床试验的成本管理提供测算方法。
[关键词] 医疗机构；药物临床试验；成本管理
[中图分类号] R19 [文献标识码] A [文章编号] 1672-5654（2018）08（a）-0126-03
[Abstract] With the continuous increase of input force of our state and society to the new drug research and development， the number of medical institutions receiving the drug clinical test gradually increases， and the cost accounting is not conducted in the clinical test work of drugs in many medical institutions， difficult to provide the precise cost of clinical test， and the medical institutions usually receive the budget provided by the bid party when signing up the research agreement. The construction input of medical institutions to the drug clinical test institutions is difficult to recover the cost by developing the drug clinical test， affecting the input enthusiasm of medical institutions to the clinical test work. The paper studies the cost of developing the drug clinical test， thus providing measurement method for the cost management of drug clinical test.
[Key words] Medical institution； Drug clinical test； Cost management
药物临床试验是指任何在人体（患者或健康志愿者）进行药物的系统性研究，目的是确定试验药物的疗效与安全性。通常发起该药临床试验的申办方（如制药企业、合同研究组织等）不具备实施临床试验的条件和资质，需要委托医疗机构开展药物临床試验，并与医疗机构签订临床研究协议[1]。
随着临床试验数量的增长，药物临床试验...
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