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Frequently Asked Questions
What is a Clinical Research Trial?
A clinical research trial is designed to test the effects and/or safety of an investigational medication, medical treatment, or device on a group of volunteers. Clinical research trials are an important step in making new medications available for future use.
How is a Drug Approved for Testing?
The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical research studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.
Who can be in a Clinical Research Trial?
People with the condition being studied as well as healthy people can volunteer to participate in a trial. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve people with the condition being studied. Each trial has specific requirements such as age, sex, or medical condition for participants. The physician conducting the trial will review each volunteer’s medical history and the trial requirements to determine who can participate. Known risks and discomforts will be explained by the trial physician prior to participating in the trial. In addition to the known risks, there may be unknown risks such as medication side effects involved participating in a clinical research trial. Trial procedures, risks, and benefits are explained to volunteers during the informed consent process.
What is Informed Consent?
Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical research trial. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research trial.
Who is the Institutional Review Board (IRB)?
The IRB is a group of healthcare professionals and members of the local community that must review and approve a clinical research trial before it begins. The IRB carefully reviews trial activities because its primary responsibility is to protect the safety and rights of trial participants.