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題名 | Clinical Trial--What is It? |
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作者姓名(中文) | 李慶三; | 書刊名 | 藥學雜誌 |
卷期 | 25:3=100 2009.09[民98.09] |
頁次 | 頁12-21 |
分類號 | 418.1 |
關鍵詞 | 臨床試驗; 有效性和安全性; 市場行銷許可; 副作用長期追蹤; 新藥開發; 新藥審核規格國際化; Clinical trial; Efficacy and safety; International outsourcing; Investigational drug; Post marketing surveillance; |
語文 | 英文(English) |
中文摘要 | 臨床試驗的目的在於探討新藥在人體的有效性和安全性。製藥工業贊助的臨床試驗通常區分為四個階段,第一階段以單劑量和多次投予的方式來測試正常人對新藥的忍受度,第二階段測試新藥對數百個無併發症病人的初步療效和安全性,第三階段擴大試體數目達千人,並可包括多種病變病人,目的在統計證實新藥的有效性。在第三階段臨床試驗結束之後,業者即可將臨床試驗分析結果呈送相關機構審核,如經核准,即可取得市場行銷許可。在藥品行銷期中,臨床試驗仍持續進行,此為第四階段,目的在於對副作用的長期追蹤。如果發現不良反應,審核機構有權力宣布藥品回收,中止銷售。因為研究參與感和實質經濟效益,有意願參加臨床試驗的醫師明顯增加。美國無疑是臨床試驗最大市場,因為新藥審核規格的國際化,使其他國家的醫師也有參與臨床研究的機會。縱使世界性經濟風暴,製藥業者仍然會持續投資新藥開發。以高科技和高品質人力資源,台灣有競爭力來爭取國際臨床試驗的商機。 |
英文摘要 | A clinical trial is a prospective study that investigates the efficacy and safety of a new treatment in human subjects. Most industry-sponsored treatment trials are conventionally divided into four phases. Phase I trials are intended to assess the safety, tolerability and pharmacokinetics of the investigational drug. Two most notable, early Phase I trials are the single ascending dose (SAD) and the multiple ascending dose (MAD) studies. These studies are respectively designed to determine the maximum tolerated dose (MTD) that can be given as a single dose and as multiple doses before unacceptable toxicities are experienced by the study subjects. If MAD study signifies safety and tolerability of the drug, Phase II studies ensue in patients with specific disease or condition. The purpose is to explore whether the drug exhibits credible efficacy and acceptable safety in actual patients. Phase III trial is designed to statistically confirm the efficacy of a new treatment in a larger patient population across multiple trial centers. Typically, two well controlled Phase III trials, at a minimum, are required for marketing approval. Phase IV trial, also known as the post marketing surveillance study, is mandated by most regulatory authorities to track any rare or long term adverse events that failed to emerge during the Phase III trials. Harmful adverse events discovered in the Phase IV follow-up may result in product recall or voluntary withdrawal from the market. The pharmaceutical sponsor customarily provides the investigator with a clinical protocol and an Investigator's Brochure, which are included as parts of the IRB submission for study approval. Drug makers will continue to fund clinical trials to supplement their product portfolios, despite the economical downturn and the continuing merger/acquisition activities. Excited by the opportunity to gain first-hand experience with cutting-edge therapies, an increasing number of clinicians have become interested in the clinical trial. Unequivocally, the largest clinical trial market is the United States; however, pharmaceutical globalization and ICH harmonization extend the clinical trial opportunity to international investigators. Driven by economic factors such as cost, efficiency and regulatory climate, the international outsourcing is on the rise. With a knowledgeable and skillful work force, Taiwan is in a strong position to benefit from the globalized clinical trial business. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。