If you have a troubling skin disease, should you volunteer for a dermatology clinical trial? Here are 5 key questions you should ask.
In this study is your safety protected by an Investigational Review Board (IRB)?
An IRB is made up of doctors, researchers, and members of the community, whose role is to make sure that the study is ethical and to protect the rights and welfare of participants.
Are all services and drugs free of charge?
Companies testing drugs and devices typically pay ALL the costs for a legitimate clinical study. Patients who need to pay for anything should certainly ask “why?” and approach the trial with caution.
Does the coordinator pay you modestly for your participation?
It is customary to reimburse patients for time and travel, but unethical to pay so much that a patient participates mostly because of the money.
Are you asked to read an “informed consent form”?
These forms, which are mandatory, should clearly spell out the benefits and risks for you, as well each party’s obligations.
Does the coordinator tell you that not necessarily all patients in the clinical trial will get an active drug?
Most, though not all, clinical trials give some patients a “placebo”. A placebo is a pill or injection that does not contain active medication. This helps the FDA evaluate whether the drug is safe and effective.
You can find detailed information about individual dermatology clinical trials at clinicaltrials.gov. Just because you see a trial you see on that site, does not necessarily mean it has been registered or approved by the FDA.
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