What is a Clinical Research Study?
A clinical research study is designed to test the effects and/or safety of an investigational medication, medical treatment, or device on a group of volunteers. Clinical research studies 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 Study?
People with the condition being studied as well as healthy people can volunteer to participate in a study. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve people with the condition being studied. Each study has specific requirements such as age, sex or medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician prior to participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects involved participating in a clinical research study. Study 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 study. 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 study.
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 study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of study participants.