Very often, people who wish to participate in a clinical study are reluctant to take the plunge for fear of the possible risks. Yet, clinical trials are seriously regulated, and patient safety is at the heart of every test.
The risk can’t be zero, but it can be reduced. Reducing the risk to be minimal, this is precisely the role of the US Food and Drug Administration (FDA). Every clinical trial goes through a series of approvals, including from an Institutional Review Board (IRB). Before being set up, any clinical trial project is submitted for the approval of an Institutional Review Board (IRB). The IRB will also monitors all aspects of a clinical trial, to ensure human trial participants’ safety. At the slightest occurrence of possible danger, the IRB will stop the clinical trial.
The objective of the regulation is to reduce the risk of occurrence of side effects from the test drug. In all clinical studies, every undesirable effect is systematically listed and analyzed. The analysis of these side effects is essential as it makes possible to assess the benefit over risk ratio of a new drug.