What is done to ensure clinical trials are safe?
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Dr. Mehmet Oz answered:Clinical trials are a very regulated process. Clinical trials for new cancer treatments only get underway after there is evidence from laboratory studies (first in cells and then in animals like mice) that the treatment appears to work. The US Food and Drug Administration (FDA) uses clinical trial findings, which report safety and effectiveness, to determine whether new treatments should be approved and integrated into routine care.Clinical trials are a very regulated process. Clinical trials for new cancer treatments only get underway after there is evidence from laboratory studies (first in cells and then in animals like mice) that the treatment appears to work. The US Food... More -
By federal regulation, every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, community advocates, and others. The IRB is charged with ensuring that all clinical trials within a given medical institution are ethical and that the rights of the participants in those trials are protectedBy federal regulation, every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, community advocates, and others. The IRB is... More
