慢性阻塞性肺病(Chronic Obstructive Pulmonary Disease, COPD)是慢性呼吸道疾病，並且慢性呼吸道疾病全球前十大死亡原因之一。至今仍無藥物可完全根治的疾病，通常會漸進式的惡化，在早期其臨床症狀並不明顯。因此；往往導致被忽略，而失去治療時機，造成死亡的人數逐年攀升。目前市面上有許多控制藥物，本論文則以慢性阻塞性肺病執行中的第三期臨床試驗為研究標的，針對臨床試驗執行過程中，其文件審查項目及在台灣地區慢性阻塞性肺病試驗的藥物價值進行探討，也提及臨床試驗送審工作之重要性。慢性阻塞性肺病之臨床藥物種類繁多，須因應不同適應症以及疾病嚴重程度，本論文則著重於中重度穩定型慢性阻塞性肺病之第三期臨床試驗藥物長效抗毒蕈鹼劑，與長效乙二型刺激劑作為研究重點。
臨床試驗執行過程中，除試驗主持人與試驗團隊外，文件送審與監督責任也是試驗中重要的一環。由於本論文嚴重中之第三臨床試驗還在試驗階段，且各國送審流程及相關法規也不盡相同，因此；本研究則以台灣地區近年人體試驗審查委員會送審流程及發展變化為主要範疇。
Chronic Obstructive Pulmonary Disease (COPD), one of the top 10 leading causes of death, is a chronic respiratory disease with no ideal treatment currently. The symptoms of Chronic Obstructive Pulmonary Disease are not obvious at first and will get worse with time. Therefore, the reason why patients of COPD will have bad prognosis and high mortality is the delay for treatment caused by ignored the symptoms. At this thesis, we focus on the preparation and value of ongoing phase III clinical trials for COPD and describe the importance of the preparation for IRB documents applied for a clinical trial. Many kinds of clinical trial medicines for COPD, it will vary from different indications and disease severity. Hence, we focus on the evaluation of long-acting anti-muscarinic agent and long-acting beta agonist to be the phase III clinical trial drug for treatment of moderate to severe COPD.
Besides the PI and crew of the clinical trial, the quality of documents for IRB and clinical trial inspection are also play the critical role. In addition, we discuss the development of Institutional Review Board (IRB) reviewing process in Taiwan.
