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?
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.
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.
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.
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.