Why are Clinical Trials Needed?
Researchers are constantly looking for better ways of treating illness and
disease, but their discoveries cannot be put into general use until controlled testing has
been done. Clinical trials are the only way that testing can be done. The Food and Drug
Administration (FDA) requires clinical trials before it can approve a new treatment as
safe and effective for public use.
Who conducts Clinical Trials?
Pharmaceutical companies, research institutions, or other health organizations may be the
sponsor of a clinical trial. The sponsor is responsible for funding and for designing the
protocol. A protocol is a set of detailed guidelines that clinical investigators
follow in order to conduct the same trial at several different locations. However, only
trained doctors, nurses, and medical researchers actually conduct the trial itself.
How am I protected as a patient?
As a patient under a doctor's supervision, you are protected by the same laws and ethics
that normally regulate the medical profession. Informed consent helps protect you by
making sure you have been given all the necessary information about a trial. The FDA requires an
Institutional Review Board (IRB) to review the general process of the trial.
The IRB essentially acts as an ethics committee. As part of this role,
the IRB regulates clinical trial advertisements to avoid misleading
claims. Progress reports on clinical trials must be submitted at least
annually to the IRB.
How are new medications approved? Pre-clinical testing. A pharmaceutical company conducts laboratory and animal
studies to show biological activity of the compound against the targeted disease, and the
compound is evaluated for safety. These tests take approximately 6.5 years.
Investigational New Drug Application (IND). Next, the company files
an IND with the FDA to begin the testing in humans. The IND shows (among other things)
results of the previous studies; how, where, and by whom the new studies will be conducted;
any toxic effects found in the animal studies; and how it is thought to work in the body.
The IND must be reviewed and approved by the FDA.
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