Oversight and management of a cell therapy clinical trial network: Experience and lessons learned

详细信息    查看全文

• 作者：Lemuel A. Moyé ; ^a ; ¹ ; ^{Lemmoye@msn.com"" rel=""nofollow} ; Shelly L. Sayre^a ; ¹ ; Lynette Westbrook^b ; ¹ ; Beth C. Jorgenson^c ; ¹ ; Eileen Handberg^d ; ¹ ; Saif Anwaruddin^e ; ¹ ; Kristi A. Wagner^d ; ¹ ; Sonia I. Skarlatos^f ; ¹
• 关键词：Cell therapy ; Clinical trial network ; Institutional Review Boards ; Data Safety and Monitoring Boards
• 刊名：Contemporary Clinical Trials
• 出版年：2011
• 出版时间：September 2011
• 年：2011
• 卷：32
• 期：5
• 页码：614-619
• 全文大小：326 K

文摘

The Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the National Heart, Lung, and Blood Institute (NHLBI), was established to develop, coordinate, and conduct multiple collaborative protocols testing the effects of cell therapy on cardiovascular diseases. The Network was born into a difficult political and ethical climate created by the recent removal of a dozen drugs from the US formulary and the temporary halting of 27 gene therapy trials due to safety concerns. This article describes the Network's challenges as it initiated three protocols in a polarized cultural atmosphere at a time when oversight bodies were positioning themselves for the tightest vigilance of promising new therapies. Effective strategies involving ongoing education, open communication, and relationship building with the oversight community are discussed.