Page 10 - Senior Times South Central Michigan - November 2018 - 25-11
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Page 10
Senior Times - November 2018
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2517 W DICKMAN ROAD IN BATTLE CREEK
269-245-2232
UNDERSTANDING INVESTIGATIONAL DRUGS
Have you ever thought about joining a clinical trial that is trying to find out if an investigational drug works in treating your disease or medical condition? Or maybe your healthcare provider has talked to you about treating you with an investiga- tional drug through expanded access. An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it.
Scientists are trying to prove in clinical trials:
• If the drug is safe and effective.
• How the drug might be used in that
disease.
• How much of the drug is needed.
• Information about the potential ben-
efits and risks of taking the drug.
How can you know when it is
a good idea to consider using an investigational drug? Not every person’s disease or medical condition responds the same way to approved drugs. Your healthcare provider might have talked to you about using an investigational drug if you have:
• Experienced side effects that are
too severe to continue taking.
• Limited treatment options available. • Heard about promising early study
results for a specific investigational
drug.
• No approved drugs available to
treat your disease or medical condition.
Questions you may want to consider. If your healthcare provider thinks that using an investigational drug is an option for you, then con- sider asking questions like those list- ed below before deciding whether it is right for you.
• What is this drug being studied for?
• Are there other drugs that are already approved to treat your dis- ease or condition?
o Have you already tried them?
o Why or why not?
Many of these questions may be answered for you when you read the informed consent document. Before you can be given an investigational drug either through a clinical trial
or through expanded access, your healthcare provider must give you additional information about the potential risks and potential benefits of the drug.
As promising as an investiga- tional drug may sound it is still being tested in clinical trials to determine if it can be used to treat a disease or medical condition. Be sure to address your questions and know your risks before going for- ward in any trial.
Not everyone who wants to enroll in a clinical trial will be able to par- ticipate. Clinical trials have strict inclusion and exclusion criteria about who can participate. The criteria can be based on such factors as:
• Having a certain type or stage of
disease.
• Having received (or not received) a
certain kind of therapy in the past. • Being in a certain age group.
• Your medical history.
• Your current health status.
Criteria like those listed above can help researchers understand the medical differences among people
in the trial and help them answer
the questions they are studying
about the drug. Finally, remember that approved drugs have completed extensive testing in clinical trials
and there is scientific proof that they are safe and effective for treating
the particular disease or medical condition that has been studied. It is important to talk with your health- care provider on a regular basis about the medicines you are taking and talking about the side effects you may be experiencing.
Food and Drug Administration’s (FDA) For Patients page is the source for this article with the full article and the latest updates on FDA regulated products available at https://www.fda.gov.
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• •
Is there a clinical trial site near you?
How much is already known about the investigational drug?
o What basis is there for thinking that the drug will work better for your medical condition than using an approved treatment?
o What scientific evidence is avail- able to support the use of this investigational drug?
o What are the potential risks of using this investigational drug?
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From
Rose Baran, PharmD, Special to Senior Times
The Village of


































































































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