WHAT IS A CLINICAL TRIAL?

Before the FDA can approve a new drug, device, or treatment, it must go through a series of studies to test its safety and effectiveness in treating a condition. These studies also determine possible side effects.

These studies are called Clinical Trials.

For more information on Clinical Trials visit www.clinicaltrials.gov.

 

WHAT IS THE PURPOSE OF CLINICAL TRIALS?

The purpose of a Clinical Trial is to determine if a new drug, device, or treatment is safe and effective for the treatment or prevention of a specific medical condition. All new drugs, devices, or treatments must pass three phases of tests before the US FDA approves them for use by the public.

 

SHOULD I VOLUNTEER FOR A CLINICAL TRIAL?

New discoveries are always being made in pharmaceuticals, medical devices, and treatments. These discoveries offer promising new ways to treat diseases and conditions that affect millions of people. However, before these treatments can be made available, they must go through the Clinical Trial process to test their effectiveness, safety, and side effects.

By volunteering to participate in a clinical trial, you are helping to bring these new discoveries to life.

 

DOES IT COST ANYTHING TO PARTICIPATE IN A CLINICAL TRIAL?

There is never any monetary cost to volunteer for a Clinical Trial. Neither you nor your insurance company will ever be charged for any medical care, medication, lab work, diagnostics or other treatment you recieve as a Clinical Trial volunteer.

Of course, it will take some of your time to participate, but you may be compensated for your time and travel expenses.

 

WHAT ARE THE BENEFITS OF VOLUNTEERING FOR A CLINICAL TRIAL?

When you volunteer to participate in a Clinical Trial, you are helping to bring a new drug, device, therapy, or treatment one step closer to helping people affected by the condition being tested.

You’ll also have the benefit of physician care and consultation during the study, and learning more about your condition.

 

WHAT IS A RANDOMIZED CONTROLLED CLINICAL TRIAL?

In a Randomized Controlled Clinical Trial, neither the patient nor the doctor is aware of whether the patient received the real trial medication or a placebo “sugar pill”. The scientific community and the US Food & Drug Administration agree that this type of test is the best way to determine if a drug is really working as intended.

 

WHAT ARE THE PHASES OF A CLINICAL TRIAL?

In phase 1, a small number of healthy volunteers receives the new drug, device or treatment to determine their safety.

In phase 2, a small number of human volunteers are tested to determine what dose is best.

In phase 3, a large number of patients are tested to determine if it is effective.

In phase 4, the FDA monitors the approved drug or treatment for public safety and side effects.