Below you will find the answers to some of our patients' most frequently asked questions.


If you don't find the answer to your question please feel free to Contact Us for additional information.


What is a Clinical Trial?

A clinical trial, also referred to as a research study, is a scientific study that evaluates the safety and effectiveness of an investigational medication. A clinical trial may show that the investigational medication is better than, as good as, or no better than the standard treatment or inactive placebo.

Qualified doctors, nurses and other medical professionals conduct the clinical trial.

To help ensure that a clinical trial is ethical and that volunteers' rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.

It is only through the completion of clinical trials that investigational medications can be evaluated, and if proven safe and effective, approved for general use by the U. S. Food and Drug Administration (FDA).

All prescription medications in use today were first proven safe and effective in clinical trials.


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What are the Four Phases of Clinical Trials?

Clinical trials of experimental drugs proceed through four phases: Phase I, Phase II, Phase III, and Phase IV.

  • Phase I: Tests a new drug, device or treatment in a small group of people (20-80). The effective dose of the drug and adverse effects in humans are not yet known.

       The purpose of a Phase I trial is to determine the safe dose of a drug, to assess adverse effects and to study how the drug is metabolized.

  • Phase II: The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

       All participants receive the study drug at the same dose and on the same schedule. If the drug appears promising, based on the participants' response rate and response duration, further development may be pursued in a Phase III trial.

  • Phase III: Usually a multi-center study where the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase III trials compare the proposed treatment with at lease one other existing effective therapy.

  • Phase IV: Done after the drug or treatment has been approved for marketing (i.e. FDA approved and commercially available). These studies continue testing the study drug or treatment to collect information about its effect in various populations and any side effect associated with long-term use.

This phase also assesses other uses for the drug, know as off-label uses.

What is an investigational study medication?

An investigational study medication is a medication that has not yet been approved by the FDA for prescription by doctors.


What is placebo?  Is there a chance I will receive a placebo?

A placebo, also known as a "sugar pill," contains no active medication.

A placebo is used in clinical trials to determine if the active medication being evaluated is safer and more effective than no treatment at all.

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Why are clinical trials important?

Clinical trials facilitate the development of new and alternative drug treatments. These drugs, in turn, may present an alternative course of treatment for a patient.

These trials also assist drug manufacturers in making informed decisions about whether to pursue bringing a new technology to the marketplace.

Ultimately, these trials continue to assist the industry's efforts at developing medications that are safer, easier to administer, and most importantly more effective.




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Who can participate in a clinical trial?

Only volunteers who meet all of the eligibility criteria for a study may take part.

Our study staff will review your medical history and current medical status against the eligibility criteria.  They will determine if you may qualify to participate in the study.

You may also be asked to provide information form your medical records to help the study staff determine if you qualify.


Why should I participate?

By volunteering in a clinical trial, you may help in the development of new medical therapies that may offer better treatment, or even cures, for life-threatening or chronic diseases.

People participate in clinical trials for various reasons:

  • to help in the advancement of science
  • to get medical care
  • in hopes of trying the latest treatment for a particular disease or condition

It is important that you make an informed choice about volunteering for a clinical trial. Before signing an informed consent form, you must read it, understand it, and ask pertinent questions about the protocol. You always have the right, for any reason, to withdraw your consent and remove yourself from the study.


Is participation in clinical research voluntary? Can I withdraw from the study after I have started?

Yes, participation in any clinical research study is completely voluntary.

If you decide to participate in a clinical research study, you are always free to withdraw at any time, for any reason, without any penalty or effect on your future medical care.

If you decide to withdraw early from the study, you will be asked to notify our research staff before doing so; you will be asked to return to our research site at least once to complete a final visit and return any unused study medications.

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What happens to my personal information?

Information about your personal health is private and confidential. With your permission, the information you provide about your medical history and health condition can be transferred to the study physician's office of your choice.

If you pre-qualify for the study, a representative from our research center will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA or similar agencies in other countries.

Scientific presentations of study results will not include information that could in any way identify you.

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What happens during a trial?

Our research staff is happy to spend the time with you to discuss the medical aspects of the study. The details of the clinical trial will be disclosed to you in its entirety - including any possible side effects. All your questions will be answered prior to asking for a Consent to Participate.

If you qualify and decide you want to take part, you will be given a written document called an Informed Consent Form (ICF) that puts down in writing the study's purpose, and the procedures, benefits, risks, discomforts, and precautions of the study.

Your responsibilities and expectations will be discussed. It is important that you feel 100% comfortable with the role you will be playing as a clinical trial participant. You should feel free to discuss your medical treatment with your primary physician or healthcare provider at any time.You will have the opportunity to ask questions and decide if taking part is right for you.

Once you have given proper consent to participate in the clinical study, you will be enrolled into the clinical research study, then receive a physical examination, your medical history will be thoroughly reviewed and any required testing will be performed at no cost to you or your insurance company.

In a clinical drug, device or treatment trial, a volunteer is randomly assigned to receive either an investigational medication, a medication already commercially available, or a placebo. Throughout the study, the volunteer returns for regular check-ups to make sure that the treatment is safe and effective.

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What happens after a study is complete?

All study participants will receive an End of Study Visit. This visit includes a physical, review of present health condition and any final laboratory or radiology testing as required. Once the study is complete, study participants will return to their regular medical care. 

In some cases, an extension to the original study is provided - allowing patients to continue on their current course of therapy.

All information from the trial is collected and analyzed. FDA medical advisers and specialists carefully and thoroughly review the information before approving any new drug or device.




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