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.
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.
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.
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.
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.
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.
No. Visits are covered by the sponsor and pt/caregiver stipends may be provided if eligible.