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What is a clinical Trial?

Posted May 05 2009 5:55pm
Clinical trials are research studies that evaluate and test new drugs, medical devices, medical procedures, or combinations of treatments.

Most people believe that clinical trials are limited to testing drugs. This is not the case.

A good example is the Alzheimer's Disease Genetics Study which is designed to identify the genes that are responsible for causing Alzheimer's Disease. This clinical trial started in 2002 and is still recruiting participants.

You might be surprised to learn that there are ongoing clinical trials for new dental products, back pain, headaches, sleeping disorders, and just about anything you can imagine.

Most clinical trials pay for out of pocket costs like travel, and some pay a fee for participation. The drug or product is supplied free of charge to study participants.

Clinical research trials are important because they bridge the divide between what is discovered in the laboratory and the actual product that is made available to patients.

The clinical trial process is often long, expensive, and laborious.

There are three phases to a clinical trial (Phase I, Phase II and Phase III). At each stage the trial must receive approval from the Food and Drug Administration (FDA) before the research can be moved to the next phase (stage). Typically, it is many years before a new drug or new product receives final approval from the FDA.

The end product of a clinical trial must prove to be safe and effective in thousands of human participants before it can be offered and sold to the public.

This is the first in a series on Clinical Trials. I am receiving emails asking me about clinical trials; and, I intend to cover all the issues surrounding clinical trials from A- Z in a series of articles here on the Alzheimer's Reading Room.

To find a clinical trial go to – ClinicalTrials.gov.
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Bob DeMarco is a citizen journalist and Caregiver. In addition to being an experienced writer he taught at the University of Georgia , was an Associate Director and Limited Partner at Bear Stearns, the CEO of IP Group, and a mentor. Bob currently resides in Delray Beach, FL where he cares for his mother, Dorothy, who suffers from Alzheimer's disease.

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