Don't sign up for a clinical trial unless you (or a family member) are willing and able to become thoroughly informed about the process. Here are a some important questions to get you started:
- What's the purpose of the clinical trial? (In most cases, a trial doesn't result in a cure.)
- Is the trial you are considering best for your situation?
- What advantages, if any, might the experimental treatment offer over existing treatments? What are the risks? (Many clinical trials are for " me-too " drugs that offer commercial benefit to drug manufacturers but little added benefit to patients.)
- Who's paying for the study? Does your doctor or the investigator have a financial stake in the outcome?
- Is the experimental treatment being compared with a standard treatment or a placebo? (In the latter case, patients may be getting no treatment at all.) Patients in the control group also may get the standard treatment and placebo rather than the experimental treatment.
- What if something goes wrong during or after the trial and you need extra medical care? Who pays?
- What happens if you enroll in the trial and later decide that you want out?
- Can you stay on the treatment after the study is completed? If so, who will pay for the treatment?
"While there are many safeguards in clinical trials, there's no substitute for an educated participant," says David A. Lepay, the Food and Drug Administration's senior adviser for clinical science. "It's the best possible control for assuring their own protection."
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