Interested, yet unsure of your decision to participate in a clinical trial? While participation can be medically and personally beneficial, there are a few key questions you should ask before you enroll. With the right questions and answers participating in a clinical trial can be a rewarding and beneficial experience.

Q.Why are they doing the study?

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Before participating in a trial you should know the reason for the trial. Are they testing to determine the safety of the medication, the correct dosage levels, the effectiveness of the medication, or a combination of these? Knowing why the study is being done, and if it fits your expectations, is key to successful participation.

Q.Has this drug ever been studied before?

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Clinical research on a particular drug or treatment goes through several phases — labeled from 0 through 4.  Ehrhardt Clinical Research conducts trials in phases 2-4. By the time a drug has reached phase 2 there is data available concerning the safety and background of the medication. Before you agree to participate in clinical research, ask your doctor for this information.

Q.How is the medication given?

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Investigational medications can be administered in many forms: orally, rectally, topically, through an injection, even through an IV infusion. Make sure you understand the route of administration and are comfortable with it before you participate.

Q.Are there side effects to the investigational drug and how do they compare with drugs already on the market for this condition?

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All medications, even those approved by the FDA, have side effects or risks you should know about. Make sure you ask about these side effects and risks and their comparison to approved medications.

Q.Will the study use a placebo (non-active comparison drug or therapy)?

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Data from studies on an investigational drug must prove safe and beneficial before FDA approval is given. To ensure accurate results, data from patients taking the real drug must be compared to patients taking a non-active drug. This way a real benefit or risk can be proven or dispelled. You will not know whether you are receiving the investigational drug or the non-active drug and you will not be able to select which drug you will receive.

Q.How long will I be doing the study? How often do I have to come to the clinic?

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All studies are different – some can last for years and others just a few weeks or months. Some will require frequent trips to the clinic while the others may not. Find out before you volunteer how participation will work with your personal and professional life to decide if the study is right for you.

Q.Who is taking care of me during the study?

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Although you are used to seeing your physician or the nurse at every office visit, during a clinical research study your primary contact will be with your research coordinator. You will still receive physical exams and other procedures from your doctor but your coordinator will be your first point of contact.

Q.Will doing a study cost me any money?

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You will never be asked to pay for any study related procedures, medications, or office visits during your study participation. Your insurance will not be billed for these items and there is never a deductible or co-payment for these services. The sponsor conducting the study will pay for these items.

Q.When the study ends or I stop participating in the study do I still get medical care?

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If you discontinue from a study, or at the end of the study, you will continue to receive the care you did before the study from your regular physician. You will no longer receive the study medication but your doctor will discuss and then prescribe the best course of treatment for you after you stop taking the study drug.