Frequently Asked Questions
What is a clinical trial?
A clinical trial is a research study designed to provide valuable data for a new or existing treatment, or treatment method, to determine if it is safe and effective for humans. In order to determine if a treatment is both safe and effective, testing must be conducted to provide statistical proof. According to laws and regulations, all clinical trials must be reviewed, approved and monitored by an Institutional Review Board (IRB) to ensure the ethical treatment of participants, and to ensure that all participants are fully informed about the study prior to agreeing to participate.
Who can participate in a clinical trial?
Every clinical trial has specific criteria related to the type of participants that are needed for the study. These criteria exist to ensure that good statistical data can be collected for the study to achieve its purpose. Additionally, in order to ensure that no undue risk or coercion is placed upon study volunteers, certain populations are considered special populations that must receive a higher degree of safety and ethical oversight. These populations include children/minors, pregnant women, indigents, prisoners, and other vulnerable populations.
What happens in a clinical trial?
The very first thing that will happen if you choose to volunteer for a clinical trial is you will be provided a full explanation of the study including required tests and procedures, visits that you have to attend, as well as potential risks and benefits of the study. If you agree to participate in the study, you will always be able to stop participating at any time. While in the study, you will only be asked to complete the visits and procedures that were specified in the beginning. The goal of the study is to collect valuable data from you that will help the researchers during the study.
Why do we need clinical trials?
Without clinical trials, all of the medications and treatments that we have today would not exist. In order to develop new treatments that are both safe and effective, testing must be done. The Food and Drug Administration (FDA) requires that all medical treatments or methods be vigorously tested to ensure that they are both effective and generally safe. Volunteers of clinical trials provide a valuable service to the community to help researchers advance medical science and improve healthcare for generations to come.
What questions should be asked before choosing to participate?
Volunteers are always fully informed of the study requirements, required visits, tests, procedures, etc. Additionally, volunteers are always made aware of any known or likely risks of a study or any new risks that are discovered during the study. Volunteers should ask as many questions as they need in order to feel comfortable with participating. Make sure that you know exactly what will be required of you and that you are willing to perform the required tasks in the study. Also make sure that you understand the benefits and risks of the study and that you can accept the risks of participating. You may also request to speak directly with the principal investigator of the study, and you may want to discuss the study with your primary care physician (PCP) prior to agreeing to participate.
Is participating in a clinical trial always voluntary?
YES, participation in a clinical research study is always voluntary and optional, and you can stop participating at any time. Ethical laws and regulations prevent participants of clinical research studies from being given undue influence or from being coerced into participating or continuing to participate.
How do I set up an appointment for a screening visit?
Click here to browse currently enrolling studies. Or call our office at 210-949-0122 to discuss what clinical trial you are interested in for a pre-screening call. Potential study subjects will need to sign a medical release form if additional records are required for pre-screening.
Is insurance required to take part in clinical trials?
No. Visits are covered by the sponsor and pt/caregiver stipends may be provided if eligible.
What if the study patient has an emergency?
For life-threatening emergencies, Dial 9-1-1. For non-life threatening emergency questions that cannot wait until the next business day, you may call our main clinic number at 210-949-0122.
What to do if a study medication dose is missed or run out of the investigational product?
Notify the Clinic at 210-949-0122 and leave a message with a call back number and the research nurse will contact you the day of your call.