What is a clinical trial?
A clinical trial is medical research that determines the safety and effectiveness
of a drug or treatment and discovers any side effects. The US Food and Drug Administration
(FDA) uses information gathered in clinical trials to evaluate new medications.
Who conducts a clinical trial?
Our professional staff consists of physicians, registered nurses, and clinical
research professionals. Our medical professionals have extensive experience in
evaluating investigational medications and treatment procedures.
What do I need to know before I participate?
Before you agree to participate in a research study, you’ll be given materials that
clearly explain what happens during the trial, what kind of care you will receive,
alternatives if applicable, and all the benefits and risks associated with the medication
or procedure. You’ll also be given a pre-enrollment interview in which you’ll have an
opportunity to have all your questions and concerns addressed.
It is your right to have complete information about the study in which you will
participate. The US Government requires complete and accurate disclosure, which
allows you to make an informed decision about whether or not to volunteer. Before
you are evaluated as a research participant, you will go through the consent process,
where we will provide you with an informed consent form which you must understand
and sign before enrolling. This form clearly lists the possible risks and side
effects you might experience. If your native language is not English, we will
provide translation assistance or the informed consent form will be available
in your native language.
What do I need to know before I participate?
We understand your time is valuable and compensation is typically provided for time
and travel depending on the study. Please note that every study has different rates
of compensation.
What are the risks?
Your safety is our primary concern. All procedures are first reviewed by an
independent Investigational Review Board (IRB) before they are administered.
This assures that the study is ethical and the risks are as low as possible and
worth any potential benefits. All details and risks of the study will be explained
to you during the informed consent part of your registration.
Do I qualify to participate?
Different studies have different enrollment requirements. Some require only healthy
adults not on medications and over age 18; other studies may require people with
existing medical conditions such as diabetes, anxiety, high cholesterol,
or other conditions.
See the list on the right to see our current studies. When you call, you will be
asked several questions about your current health. If you meet the study requirements,
we will schedule an appointment for you to be evaluated by our staff. If you do not
qualify for a specific study at that time, with your permission, we may contact you
regarding future clinical research studies.
What can I expect during the clinical trial?
Below is the typical process for a clinical trial:
- Screening interview – Information will be taken concerning your age, medical
history, medications, and other preliminary questions to make sure you fit the
study requirements.
- Informed consent process – You will receive materials that clearly explain
the nature of the study and how you will participate. Our research staff will tell
you of any risks or potential side effects. It is very important that you ask
questions and read the consent form carefully. You are encouraged to ask questions.
They will all be answered accurately so that you fully understand the risks and
benefits of your participation.
- Assessments and medication – Once you are enrolled in a study, you may
receive a study-related physical exam, study medication, laboratory tests, and
study procedures as necessary, free of charge. During the course of the study,
medical personnel will meet with you to monitor your progress. Our medical
professionals have extensive experience in evaluating investigational medications
and working with treatment-related procedures.
Can I change my mind?
Of course. Your participation in a research study is entirely voluntary, and you may
withdraw from participation at anytime and for any reason. During your screening visit
and throughout the study, we will completely explain the risks and benefits of your
study. If you change your mind, you may withdraw.
How do I learn about new studies?
You can register to be part of our volunteer database
here
and we will get in touch with you if you may qualify for a study.
Will my information be sold to anyone?
Never. All information you provide as a research participant is strictly confidential.
It will not be sold and will be used only for the purposes required by the research study.
What are my rights as a clinical trial participant?
You are entitled to certain rights as a clinical trial participant. Once your eligibility
for a clinical research study has been confirmed, you will receive information to help
you in make your decision of whether to participate. Prior to enrolling in
any clinical trial, it is important to understand your patient rights before and
during the clinical trial process.
Prior to Enrollment: Your Patient Rights
- Understand the potential benefits and risks to participating in a clinical trial.
- Be aware of the trial plan, i.e. length, location, etc.
- Understand what will be expected of you during the trial.
- Voice any concerns and ask any questions you have about any aspect of the trial.
After Enrollment: Your Patient Rights
- You can withdraw from the trial or decline participation at any time without loss of future treatment or judgment.
- Ask any questions you have about the trial at any point during the study.
- You will be kept up-to-date with any significant new discoveries that may affect your desire to continue participation.
