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Wednesday, June 10, 2009

My Heroes: Clinical Trial Research Participants

When it comes to health care heroes, these are some of the unsung heroes of medicine. Every year, thousands of people, young and old, healthy and sick, volunteer to try new medications through the clinical research process.

Clinical trials are an important step in the FDA approval process that a medication must complete to go from test tube to pharmacy shelf. In a clinical trial, recruited volunteers take a trial medication in one of three phases:

  1. In Phase One, a medication is given to humans for the first time and is evaluated for safety, side effects and safe dosage range.
  2. In Phase Two, a medications is evaluated for its effectiveness in treating the targeted symptoms, condition or illness.
  3. In Phase Three, a medication is studied against existing treatments to confirm its effectiveness, and final safety and side effect profiles are compiled.
While there are risks to taking a new medication for which the benefits are unproven and the side effects unknown, there are also benefits. Most volunteers sign up for clinical trials to gain access to research medications that might prove to make a difference in their health and quality of life. The clinical trials are often conducted by the top health care experts and facilities in the country. A clinical trial may offer hope when no other conventional options exist.

The one benefit
of participating in a clinical trial that makes these volunteers heroes in my eyes is the fact that clinical trial research participants help others by contributing to the advancement of medical science. Without these volunteers, new medications would never make it to the pharmacy, period.

Participating in a clinical trial is a BIG decision; I know because I have done it twice (and I am quite humble about my hero status!) Thankfully there are resources available to help you make an informed decision and determine if being in a clinical trial is right for you. For example: The Center for Information & Study on Clinical Research Participation (http://www.ciscrp.org//) helps you with information about all aspects of clinical trial participation. They were formed in 2003 as a non-profit public service organization with the mission of educating and empowering patients and their families about medical research participation. One of the tools on their website is the innovative SearchClinicalTrials.org, where you can search multiple websites at one time for clinical trials information.

So consider being a hero. Talk to your doctor and ask if participating in a clinical trial for medications to treat your health condition is right for you. And remember, even if you are healthy, you can participate in a clinical research study.


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