The Cardiology Division offers a variety of investigational devices and drugs for patients with Cardiovascular Disease. Clinical trials comes in different types
Phase I studies: Initial evaluation of a device or drug in patients. There is usually little clinical experience with these treatments and patients are selected based on the unavailability or unproven benefit of current treatment strategies. These studies are usually uncontrolled and all patients receive a treatment strategy and are followed closely for safety with only hints of efficacy obtained from these studies
Phase II studies: After evaluating a treatment strategy in phase I studies with suggested safety, phase II studies are undertaken. These are usually randomized and controlled, i.e. patients enrolled in these studies are randomly assigned to receive the new treatment of the standard available treatment. This is done because the new treatment in yet unproven and needs to be compared to standard treatments. These studies can also be blinded or double-blinded (neither patients nor physicians know the treatment administered). This will eliminate any biases in interpreting the studies and account for the placebo effect. Phase III and IV studies are more advanced and usually larger in size. There are also registries which are performed after obtaining enough evidence of a treatment's effectiveness to offer patients investigational devices prior to their FDA approval
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]).