More Information For Patients
Who can participate in a Clinical Trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called “inclusion criteria” and the factors that disallow volunteers from participating are called “exclusion criteria”. These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to indentify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.
Should I join a Trial?
As a volunteer in a clinical trial, you are participating in the development of medical therapies – therapies that may offer better treatments and even cures for life-threatening chronic diseases.
People volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not currently exist. You may join a clinical trial hoping to improve the medical care you receive. If you do not have health insurance, clinical trials are a way to receive study-related medical care.
Points to Consider
- A research study may or may not help you personally
- In the future, the results could help others who have a health problem
- Research participation is voluntary
How to Participate
Once you decide to participate, you will be provided with a written document called an informed consent. It will explain the study in detail. After you have reviewed the consent and have had a chance to have your questions answered, you can decide whether you would like to see if you qualify to be in the study.
If you and the study physician decide this study might be right for you, you will be scheduled for a screening visit to see if you qualify. Whether or not you participate is entirely up to you, and you can withdraw from the study at any time.
Participants must give consent to participate in a clinical research study and be willing to comply with all study requirements.
Patient Safety
An Institutional Review Board (IRB), which is an independent group of experts, must supervise and monitor each clinical trial to ensure that a patient’s rights are protected and that the study does not pose any undue or unnecessary risk to the patient’s safety. Any and all volunteers who wish to participate in a clinical trial must also be provided with an informed consent statement that presents the details of the research study. These include the length of the study, what medical procedures may be performed, possible medicine used, the number and frequency of visits, what will happen at those visits, the potential benefits of the treatment, and possible side effects. The informed consent also advises that the patient has the right to withdraw from the study at any time and for any reason. Prior to being included in a study the volunteer must sign the informed consent.