What Are Clinical Trials?

This information was provided by www.ovarian.org 08/12/08

Introduction to Clinical Trials

Clinical trials are research studies designed to find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. Through participation in these trials, you may receive access to new and investigational therapy options that are not available to women outside the clinical trial setting. Clinical trial designs are all screened, approved, and monitored by national health authorities, and patients who enroll in clinical trials must be treated with the best available care. Some clinical trials only enroll patients with specific disease characteristics, so it is important to note that you may not be eligible for participation in such programs.

Many women undergoing treatment for ovarian cancer choose to participate in clinical trials. Clinical trials are research studies in which people (who volunteer) help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and find better ways to prevent, screen for, diagnose or treat cancer.

Today, clinical trials are conducted in most hospitals and cancer treatment centers across the U.S. To ensure the reliability of the data and the safety of all participating patients, all clinical trial researchers conduct their studies under the strict guidelines of the U.S. Food and Drug Administration (the FDA)

Should You Participate in A Clinical Trial?

Whether you should join a clinical trial requires a lot of thought and consideration and is a decision that should make in close consultation with your healthcare team and your loved ones.

Keep in mind:

  • Clinical trials are only open to people who meet very specific medical requirements; every person is not eligible for each clinical trial.
  • Clinical trial participants can be among the first to receive new treatments before they hit the market. But remember, these treatments are under investigation and may have potential side effects.
  • It is your right to withdraw from a clinical trial at any time.
  • For many women with ovarian cancer, especially those experiencing resistant or recurrent ovarian cancer, investigational treatments can offer new hope.

It is important to ask questions before deciding to enter a clinical trial. Some questions to ask your doctor and the clinical trial staff include:

  • What is the purpose of the study?
  • Who is conducting the trial?
  • Am I eligible to participate?
  • What type of treatments or tests will I have to take?
  • Why do the researchers think the treatment being tested may be effective?
  • Has the treatment been tested before?
  • What are the benefits and risks of participation?
  • Does the treatment have side effects?
  • How long will the study last?
  • Will my insurance cover the costs?
  • Can my doctor stay involved?

States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial.

"Routine patient care costs" are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., that you would receive whether or not you were participating in a clinical trial. Some health plans don’t cover these costs once you join a trial, even though studies have shown that they are not appreciably higher than costs for patients who are not enrolled in trials. For information, please click visit http://cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-....