12/14/2012 9:24:00 AM Dr. K for Dec. 14, 2012 Ask the right questions before participating in clinical trial
DEAR DOCTOR K: I have prostate disease and treatment hasn't worked. My doctor suggested I participate in a clinical trial. I'd like to know more before I give him an answer.
DEAR READER: When established treatments aren't effective, participation in a clinical trial can be a good option. Such trials give you access to promising treatments that might work better than one already on the market.
On the other hand, clinical trials test treatments that are still under investigation. There may be unpleasant or serious side effects. Clinical trials are designed to minimize risks to participants, but they cannot completely eliminate them.
In most clinical trials, a new and not yet proven treatment is compared to a placebo, an inactive treatment designed to look like the real one, often called a "sugar pill." So if you participate in a placebo-controlled study, you could receive a placebo instead of the active treatment. Neither you nor the doctors conducting the clinical trial will know until the trial is over which one you took.
Some people don't like the fact that they might take a placebo. Here's what I tell my patients who feel this way: If the new treatment being tested turns out to be effective, you'll ultimately benefit -- and you'll have helped many others. On the other hand, if the new treatment turns out to be ineffective, and maybe also to have bad side effects, you'll have been lucky.
Before you make your decision, ask these questions:
-- Why is the study being done?
-- Have other studies evaluated this drug or procedure? What were the results?
-- Is there a chance I will receive a placebo?
-- What are the possible risks and benefits of participating?
-- What other treatment options do I have?
-- What treatments, tests and medical procedures will I receive?
-- Can I keep taking my regular medications?
-- Will I have to pay for any treatments or tests?
-- If the investigational drug or treatment works for me, can I continue to receive it when the trial ends?
-- Who will be responsible for my care?
If you agree to join the study and later change your mind, you are free to stop participating. Ask what care you will receive if you leave the study before it concludes.
Just because your doctor has suggested that you participate in a clinical trial does not mean you need to say yes. If you say no, your medical care and your relationship with your doctor will not be affected.
Clinical trials currently enrolling patients are listed online at www.clinicaltrials.gov. Readers may be surprised to learn how many trials are going on in their community that could help with a condition they have.
(Dr. Komaroff is a physician and professor at Harvard Medical School. To send questions, go to AskDoctorK.com, or write: Ask Doctor K, 10 Shattuck St., Second Floor, Boston, MA 02115.)