Thinking of the ethical protection in clinical trial for orphan drugs
ZHANG Ai-li1 LI Jing1 LI Yi2 HE Wen-ji3 PANG Xue-jing4 TAO Na5WANG Mei-fen6 ZHANG Zhen7▲ LI Cong-mei2
1.Department of Scientific Research,Affiliated Yan′an Hospital of Kunming Medical University,Yunnan Province,Kunming 650051,China;
2.Department of Medical Quality,Affiliated Yan′an Hospital of Kunming Medical University,Yunnan Province,Kunming 650051,China;
3.Department of Cardiology,Affiliated Children′s Hospital of Kunming Medical University,Yunnan Province,Kunming 650034,China;
4.Department of Stomatology,Affiliated Children′s Hospital of Kunming Medical University,Yunnan Province,Kunming 650034,China;
5.Department of Endocrinology,Affiliated Children′s Hospital of Kunming Medical University,Yunnan Province,Kunming 650034,China;
6.Department of the First Infectious Disease,Affiliated Children′s Hospital of Kunming Medical University,Yunnan Province,Kunming 650034,China;
7.Pediatric Disease Research Institute of Yunnan Province,Affiliated Children′s Hospital of Kunming Medical U-niversity,Yunnan Province,Kunming 650034,China
Abstract：Rare diseases are also known as orphan diseases,so drugs for rare diseases are also called orphan drugs.Drugs clinical trial is the prerequisite to the research of orphan drugs before they appear on the market.In view of the pathological characteristics of rare diseases patients and the inaccessibility of orphan drugs in China,ethical review is an important means to protect the rights and interests of subjects involved in drug clinical trials as well as a moral guarantee to regulate the procedure of clinical trials for orphan drugs.This thesis explores the ethical protection of orphan drugs clinical trial in the fields of clinical trial protocol,information consent,and privacy protection,with a view to raising people′s awareness to the importance of ethical review of clinical trials for orphan drugs.
U.S.Food and Drug Administration （FDA）.Rare diseases take spotlight in annual event[EB/OL].http://www.fda.gov/For-Consumers/ConsumerUpdates/ucm244408.htm，2011-02-24.
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