Clinical Research and Phases

FDA Guidelines

Research done under the direction and supervision of the FDA (Federal Drug Administration) follows a number of phases.

PHASE ONE: Early on, the pharmaceutical companies present a new compound purported to treat any one of a number of diseases, and must proved both safety and some evidence of efficacy (the drug working for the purpose for which it was intended) in animals. After FDA review, the drug is then tested first in people without any clinical disease to establish safety and dose tolerability. Then, if found to be safe and dosage levels have been tested, the drug is exposed to patients with the actual disease that is meant to be treated.

PHASE TWO: The second stage of research involves a proof of concept with treating patients with the disease to show evidence of confirming safety, and evidence that the drug is actually working.

PHASE THREE: Finally, if the drug is showing promise, then phase three studies, which are performed on a much larger scale, are initiated and this is the last step before presentation to the FDA to get the drug officially approved, and on the market available to patients for that particular disease.

At Brain Matters Research, we are involved in phase one disease specific trials, phase two proof of concept trials, and many phase three trials where drugs are deemed safe and very promising, and on the runway to the FDA, hoping for imminent approval.

Read some Myths vs. Facts in Alzheimer’s Clinical Trials



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