Sponsor-investigator-relationship: challenges, recent regulatory developments and future legislative trends  

作　　者：Raphael Richard Ciuman 

机构地区：[1]不详

出　　处：《Health》2011年第12期772-781,共10页健康（英文）

摘　　要：Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes, international and national legislations and regulations. This implicated various alterations and shifts of essential responsibilities and tasks relating to the investigator, sponsor or sponsor-investigator what raised financial, clinical and ethical issues. First experiences with these new regulations and legislations are discussed together with international differences and their impacts on clinical trials. Regarding non-commercial trials and institutional sponsorship, there are still open organizational and legal questions after national implementation of the Europeam Clinical Trials Directive in 2004, although various approaches have been suggested in recent years in Europe. Current trends and controversies are discussed as well. A literature review was performed summarizing recent experiences with current legislations and risen controversies of these new legislations showing impact on future trends.Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes, international and national legislations and regulations. This implicated various alterations and shifts of essential responsibilities and tasks relating to the investigator, sponsor or sponsor-investigator what raised financial, clinical and ethical issues. First experiences with these new regulations and legislations are discussed together with international differences and their impacts on clinical trials. Regarding non-commercial trials and institutional sponsorship, there are still open organizational and legal questions after national implementation of the Europeam Clinical Trials Directive in 2004, although various approaches have been suggested in recent years in Europe. Current trends and controversies are discussed as well. A literature review was performed summarizing recent experiences with current legislations and risen controversies of these new legislations showing impact on future trends.

关 键 词：INVESTIGATOR SPONSOR CLINICAL TRIAL Non-Commercial TRIAL European CLINICAL Trials Directive CONFLICT of INTEREST 

分 类 号：R73[医药卫生—肿瘤]