The Angiogenesis Research Center provides access to most investigational trials of clinical angiogenesis and novel device therapy. It has provided high volume enrollment in National multicenter clinical trials with enrollemnt of more than 150 patients in various trials to date. In addition, investigators at the centers carry out Phase I and II mechanistic and safety trials and have initiated the first cardiac angiogenesis trial via an invatigator sponsored IND. The translational structure of the center has provided a turn key approach to drug development with preliminary in vitro and in vivo testing of candidate angiogenesis agents all the way to clinical trials assisting in FDA submissions and trial design and implementation.
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All Clinical studies at the Beth Israel Deaconess Medical Center conform to the Good Clinical Guidelines established by the department of health and human services, the FDA, and the NIH. All studies are submitted for approval to the Institutional Review Board (Committee on Clinical Investigation) at the Beth Israel Deaconess Medical Center, and have to be approved prior to enrolling patients and all investigators and Research nurses have received adequate training in the proper conduct of Human Research. In addition, most of these treatment strategies are evaluated pre-clinically by these invesigastors giving them additional experience with these devices and drugs.
A properly executed written informed consent in compliance with the Declaration of Helsinki (including the Hong Kong revision of 1989) and U.S. Federal Regulation 21 CFR 50, shall be obtained from each subject prior to entering the subject into the trial or prior to performing any unusual or non-routine procedure that involves risk to the subject. A copy of the informed consent/assent document to be used will be submitted by the Investigator to the Institutional Review Board for review and approval prior to the start of the study. The Investigators provide a copy of the signed informed consent/assent to the subject and a copy shall be maintained in the subject's record file. Attention is directed to the basic elements that are required to be incorporated into the informed consent under U.S. Federal Regulations for Protection of Human Subjects (21 CFR 50.25). Additional elements of informed consent, if appropriate, must be included in the informed consent/assent document (21 CFR 50.25[b]).