A clinical research 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. 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 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. If you agree to participate, 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.