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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for Outcome Measures presentation:
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]).
