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FAQ
 
 



Q: What is a Clinical Research Study?
A:   A clinical research study involves testing or studying a drug or medical device to see if it is a safe and effective treatment for people, it is called a "trial." 

Drugs and devices must be proven to be safe and effective for people before the Food and Drug Administration (FDA) can approve them and doctors can prescribe them. The FDA has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.
Q: What are clinical trial "phases?" ?
A: Clinical trials of experimental drugs proceed through four phases:

In Phase I clinical trials, researchers test a new drug or treatment for the first time in a small group of people - about 20 to 80 - to evaluate its safety, determine a safe dosage range and identify side effects.

In Phase II clinical trials, the study drug is given to a larger group of people, about 100 to 300, to see if it is effective and to further evaluate its safety.

In Phase III studies, the study drug or treatment is given to large groups of people - from 1,000 to 3,000 - to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about its effect in various populations and gather data on any side effects associated with long-term use.
Q: What are the benefits and risks of participating in a clinical trial?

A:   

       Benefits

 

          Participating in a clinical trial allows you to:

  • Play an active role in your own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care during the trial.
  • Help others by contributing to medical research.
      Risks

  • The treatment may not be effective
  • Investigational new drugs and therapies may have unknown side effects
  • Side effects may be worse than with standard therapies
     

Q: What questions should I ask before participating?
A:
  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and treatments are involved?
  •  
    How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last? 
  • What type of long-term follow up care is part of this study?
  • Who will be in charge of my care