What is a clinical trial?
Clinical trials are research studies designed to determine whether investigational medications are safe, tolerable, and effective for humans. Data produced from these trials are used to determine if the investigational drugs will work for certain illnesses.
Clinical trial volunteers can make a difference in the future of medical care for various illnesses. By participating, you can play a more active role in managing your own health and help others who have the illness. Also, research studies allow patients to gain access to potential treatments before they are widely available.
Who can participate in a research study?
Every research protocol has a unique set of entrance criteria that must be met before you can enroll into a study. These criteria may include: your age, the severity of your disease, other medical conditions and your current medications.
Is it safe?
Discovering new medical advances are important, but patient safety comes first. Patients’ health are monitored throughout the study. Although, all clinical trials are conducted according to strict U.S. Food and Drug Administration (FDA) guidelines, there are still possible risks.
Potential risks include:
*Known side effects of the study medication
*Unknown side effects
*Experimental treatment may not work
What are my responsibilities during the study?
Participants must follow the instructions they are given. You’ll be required to attend all study appointments and to keep in contact with the study physician or coordinator.
Can I stop participating once the trial has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, please inform the study team and let them know your reasoning.
Is there a cost to participate?
No, all clinical trial related assessments and procedures are paid by the sponsors.
What is Informed Consent?
The informed consent form (ICF) explains all the details of the study. It provides information about the potential risks and expected benefits of the drugs and a detailed description of the study process. You will have as much time as you need to review the ICF. We will also sit down with you and answer any additional questions you may have. Once you fully understand and are comfortable with the process, we’ll ask you to sign the ICF, indicating your willingness to participate in the study. You will receive a copy of your ICF once it is completed.