Clinical trials research and organization

by Nathan Wei, MD, FACP, FACR

Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.

Click here: Second Opinion Arthritis Treatment Kit

If you have arthritis, you may want to consider participating in a clinical trial.

This is a carefully designed study that involves people who volunteer to receive investigational treatments while being closely supervised by a physician and other research professionals.

The physician is selected by a pharmaceutical or biotechnology company to help with the investigation.

All clinical trials are reviewed by an Institutional Review Board (IRB) to endure that proper ethics are adhered to.

IRBs protect the rights of the patient participant so that they are not exposed to unnecessary risks.

You must sign an IRB approved consent form to participate in a clinical trial.

Clinical trials are divided into 4 phases. The first phase is designed to make sure the medication is safe and often involves normal healthy volunteers. A phase 2 study looks at the drug in the disease of interest to see if the drug works for that disease and also to confirm the safety. Phase 3 studies are large multi-center double-blinded studies that involve hundreds if not thousands of patients to determine whether the drug actually works. These studies are placebo controlled because there is a significant placebo response to many arthritis therapies. In fact the placebo response may be as high as 40 per cent!

In a clinical trial you are randomized to a treatment group. Generally, neither you nor the examining physician knows what you are taking- whether it’s the active drug or the placebo. This tends to mitigate investigatory bias. (The chance of drawing placebo in a clinical trial for arthritis is exceedingly low.)

Once you’re in a study you will receive a physical exam, be told about the clinical trial visits, and also be explained the informed consent. Make sure you ask all your questions and get the answers you need to make an informed decision.

You may leave the trial at any time.

The advantages of being in a clinical trial include:

• Free study related lab tests, x-rays, and physician visits
• Access to medication or placebo with the possibility of getting access to the “real” medication after the trial in some instances
• Careful supervision from the medical staff

Look for a center that has:

• Experience with clinical trials (at least 10 years)
• A board-certified physician in that specialty
• The center has published articles
• The center is well-staffed

One of the best clinical arthritis research organizations on the East Coast is the Arthritis Treatment Center located in Frederick, Maryland. For more information about possibly participating call the Arthritis Treatment Center at 1-888-71- STUDY.

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