What to Consider Before Joining a Clinical Trial
Posted: 6/25/2013 11:30 AM by
Dear Savvy Senior,
What can you tell me about clinical trials and how to go about finding one? My wife has a chronic condition and we’re interested in trying anything that may be able to help her.
--Looking For Help
Each year, hundreds of thousands of Americans participate in clinical trials in hopes of gaining access to the latest, and possibly greatest, but not yet on the market treatments for all types of illnesses. But, you need to be aware that clinical trials can vary greatly in what they’re designed to do, so be careful to choose one that can actually benefit your wife. Here’s what you should know along with some tips for locating one.
A clinical trial is the scientific term for a test or research study of a drug, device or medical procedure using people. These trials – sponsored by drug companies, doctors, hospitals and the federal government – are conducted to learn whether a new treatment is safe and if it works. But, keep in mind that these new treatments are also unproven, so there may be risks too.
Also be aware that all clinical trials have certain eligibility criteria (age, gender, health status, etc.) that your wife must meet in order to be accepted. And before taking part in a trial, she’ll be asked to sign an informed consent agreement. She can also leave a study at any time.
Things to Know
Before deciding to participate in a trial, you and your wife need to first discuss it with her doctor. Then, schedule an appointment with the study’s medical team and ask lots of questions. Here are some to get you started.
Find a Trial
What’s the purpose of the study and can it improve your wife’s condition? You may be surprised to know that many drug or procedural trials are not designed to find a cure or improve a patient’s health, but only to provide scientific data.
What are the risks? Some treatments can have side effects that are unpleasant, serious and even life threatening.
What kinds of tests and treatments does the study involve, and how often and where they are performed?
Is the experimental treatment in the study being compared with a standard treatment or a placebo? Keep in mind that if your wife gets the placebo, she’ll be getting no treatment at all.
Who’s paying for the study? Will you have any costs, and if so, will your insurance plan or Medicare cover the rest? Sponsors of trials generally pay most of the costs, but not always.
What if something goes wrong during or after the trial and your wife needs extra medical care? Who pays?
If the treatment works, can your wife keep using it after the study?
Every year, there are more than 100,000 clinical trials conducted in the U.S. You can find them at condition-focused organizations like the American Cancer Society or the Alzheimer’s Association, or by asking her doctor who may be monitoring trials in his or her specialty.
Or, use the National Institutes of Heath’s website at clinicaltrials.gov
. This site contains a comprehensive database of federally and privately supported clinical studies in the U.S. and abroad on a wide range of diseases and conditions, including information about each trial’s purpose, who may participate, locations, and phone numbers for more details.
If, however, you don’t have Internet access or could use some help finding the right trial, use the Center for Information and Study on Clinical Research Participation (ciscrp.org
). This is a nonprofit organization that will take your wife’s information over the phone and do a thorough clinical trials search for you, and mail or email you the results in a few days. Call 877-633-4376 for assistance.