DEAR DOCTOR K:
I have a particular disease. A nearby medical school is recruiting people with my condition to participate in a research study. Should I volunteer?
There are two good reasons to consider volunteering for a study: It might help you, and it might help others. In some types of studies, there also may be risks to you.
Sometimes my patients ask me: “Do we really need to do all these medical research studies? Don’t we know what treatments work without conducting and paying for all these studies — often with taxpayer dollars?”
That’s an easy question to answer. The history of medicine is, unfortunately, filled with examples of new treatments that doctors thought should work. Indeed, most doctors predicted they would work. But when the treatments were tested, they didn’t work. Indeed, sometimes they made people worse.
And sometimes such treatments were given to many patients before a study was done to show that they were of no value, or even harmful.
Here are some things to consider as you decide whether to participate.
Every study for which you might volunteer has been carefully designed. There is a detailed written plan specifying every question you might be asked, the kind of physical examinations that might be performed, the tests that might be ordered and any treatments you might receive.
This plan must be approved by a committee called an Institutional Review Board (IRB). The IRB includes doctors, nurses, researchers and members of the community — none of whom is involved with the study. They determine whether the study has acceptably low risks for the participants.
There are different types of studies. Observational studies simply collect detailed information from you on an ongoing basis. They do not put you at risk. Studies like this discovered that people who smoked had a much higher risk of lung cancer.
Other studies, called clinical trials, require you to have a particular “intervention.” The intervention might be a diagnostic test, such as a colonoscopy. Or it might be a treatment — a medicine, a surgical procedure or another therapy.
By participating in a clinical trial, you may get access to a beneficial drug or procedure that is not yet on the market. On the other hand, there may be risks involved. One reason clinical trials are done is to determine the effectiveness of a drug and any side effects it may cause. Some clinical trials also test whether the study’s treatment is better than no treatment at all. So, if you enroll in certain types of studies, you run the risk of being assigned to a placebo (sham) treatment.
Being in a study won’t change your regular medical care. You’ll still see your usual doctor. And typically, the study (and its treatments) cost you nothing.
Many of my patients have volunteered to participate in medical studies. None I know of have experienced a complication, but it can happen. Some of them have benefited: Their condition improved because of the experimental treatment used in the study.
(This column ran originally in October 2014.)