Department of Neurosurgery and Brain Repair

Frequently Asked Questions About Clinical Trials in Neurosurgery and Brain Repair

What are Clinical Trials?

Clinical trials are scientific tests that meet the rigorous standards of national governing boards such as the Federal Drug Administration (FDA). Before any new treatment or medication is made available to the public, scientists conduct tests to determine the benefits, side-effects, limitations and other relevant information that providers or patients should know.

Clinical trials usually include participants with a specific medical concern that is related to the drug or treatment being proposed. At the USF Neuroscience Institute, some patients with a brain or spine concern are eligible to volunteer for a one of our clinical trials. For information on clinical trials, visit www.clinicaltrials.gov.

Why do they conduct clinical trials?

Clinical trials are necessary to maximize the safety of patients and to determine the best possible benefit of any given drug or procedure. Properly done, a clinical trial eliminates any biases that a company or individual investigator might have related to the proposed treatment.

When thousands of patients participate in multi-year clinical trials, we gain tremendous insight into the treatment. In ideal cases, a drug will do exactly as we thought; in other instances, a drug ends up being used for a completely different purpose than originally intended. Did you know that Rogain, the treatment for baldness, originally came to market as a treatment for high blood pressure? Viagra is another example of a drug with a very different original intention; it failed to modify hypertension but did produce an unexpected (but lucrative) side effect!

What are the benefits of participating in clinical trials?

There are some benefits for individuals who participate in drug or device studies:

Discovery: Participants may have the opportunity to try a medication or device that is not otherwise available to the public.
Intensive: Participants often receive the additional evaluations and follow-ups that may be more thorough and more frequent than what you typically receive from your provider.
Expertise: Participants usually enjoy contact with highly specialized clinicians who know the most current information related to their condition.

Does participation in a clinical trial cost anything? Do I get paid?

All study procedures are paid for by the study sponsor so participants never pay out-of-pocket. Depending on the sponsor of a clinical trial, participants and study partners may receive compensation for their time and travel while enrolled in the study.

Can everyone participate in clinical trials?

Not everyone is eligible to participate in a drug or device study. Each study has different eligibility criteria, but in general, potential participants need to be in good health, have a diagnosis that meets study criteria, and be stable for a period of time before enrolling.

How do you find out if someone is eligible for a clinical trial?

To determine if you are eligible for any current clinical trials, please consult one of our institute physicians (your primary care doctor will likely not be up-to-date on this information). Alternatively, you may call one of our clinical trial team members and discuss studies that are currently enrolling based on the participant's diagnosis and current condition.

If there is a study that fits your profile, we schedule a screening visit. First, we present the informed consent for the study to them. The informed consent is a document that explains the purpose of the study, what is involved in participation, the risks and benefits, and other important information. Then we make sure that a person is eligible for the study by performing a number of procedures, including physical exam, blood work, and interviews. Some studies require a recent CT scan or MRI that supports your diagnosis. After all documentation is collected, the investigator group determines your eligibility.

If you find out someone is eligible for a clinical trial, then what happens?

After confirmation of clinical trial eligibility and patient commitment, you will return to our physician offices to enroll and schedule your participation. If a drug is involved, you will likely be part of a blind trial in which you will randomly be assigned the actual drug or a placebo. Then, we will schedule follow-up appointments with the study coordinator and research staff. These visits are used to gather baseline data any measure changes in your symptoms (frequency will vary depending on study design).

What is a placebo?

A placebo is a substance that is made to look exactly like the study medication, but has no actual effect. Placebos help us determine if no drug is better or worse than using the proposed new treatment.

Is there a chance I will get a placebo if I participate in a clinical trial?

There is a chance that you will receive a placebo during the course of a drug study. The process is random and blind, so the researchers cannot manipulate who receives which pill. Participants who receive the placebo still benefit from ongoing evaluations and physician contacts. Additionally, some studies feature an extension phase where all individuals who complete the original study period are given active medication.

The chance you receive a placebo in a study varies. You should take this into consideration when deciding to participate in a clinical study.

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Neurosurgery & Brain Repair