What is a Clinical Research Study?

A clinical research study is a supervised evaluation of an investigational medication to determine its safety and effectiveness as a treatment for a specific disease or condition. Individuals enrolled in a study receive an investigational medication and doctors evaluate its safety and effectiveness.

In a study, patients may be divided into two or more groups: one group or groups will receive investigational medication while the other may receive a placebo. A placebo appears identical to the investigational medication, but is inactive. To prevent biased results, this study will be conducted as :double blind.” Neither the physicians nor the participants will know who is receiving the medication that is being evaluated.

All clinical research studies must follow a strict set of rules known as a “protocol.” Before any study begins, an Institutional Review Board (IRB) must review the protocol. An IRB is an independent committee brought together to assess a study’s potential benefits and risks to ensure that participants are fully informed and that their rights and welfare are fully protected.