Clinical research trials are studies used to help develop new treatments and medications for diseases. Before an investigational drug or treatment can be considered for approval by the U.S. Food and Drug Administration (FDA), it must be thought to be both safe and effective in these carefully monitored studies.
Why do people participate in clinical trials?
There are many reasons why people participate in clinical trials, such as:
Participating in a clinical trial is a way to contribute to medical science and to help doctors and researchers find better ways to treat illnesses.
Some participate in clinical trials to receive cutting-edge treatments because their illness is not responding to standard treatment.
How are people who participate in clinical trials protected?
Researchers follow extremely strict, ethical and scientific principles to make sure that patients are protected. Clinical studies are designed to “maximize possible benefits and minimize possible harms”.++ Frequent medical exams and tests are performed to ensure safety.
++Source: The Belmont Report, published 1979
Will it cost me to take part in a clinical trial?
There is no cost to you to participate in a clinical trial. Compensation for your time may be available.
What is a clinical trial protocol?
A plan of how the clinical study will be run is called a protocol. It is written to ensure that every researcher involved in the study follows the same ethical and scientific principles. The protocol is written by the study’s sponsor.
All researchers taking part in the study will use the same protocol. The protocol is reviewed and approved by the organization that sponsors the study as well as by an independent Institutional Review Board (IRB). This review board usually consists of people from a variety of backgrounds and may include health professionals, clergy and the general public. The review of the protocol is to ensure that the participants in the trial are not exposed to unreasonable or unethical risks.
What is an informed consent?
Before you give your consent to participate in a study all your questions should be answered. You can withdraw from a study at any time.
I’m interested, how can i get more information?
Our staff is here to answer any questions you have. Call us now at (727)-724-9730 and we will give you all the information you need on available trials, how you may be able to participate in them, and what you can expect once you are enrolled.