What is a Clinical Research Study?
A clinical research study or trial is a scientific study evaluating a new treatment that has shown promise in laboratory studies. It is a scientific study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses. A clinical research study is undertaken through volunteers who would like to participate in advancing medicine. Careful oversight and patient care steer the trial toward meaningful outcomes.
The Food and Drug Administration (FDA) requires clinical trials to be performed on all new and improved medications before that new treatment becomes available for public use. Prior to a new drug reaching a clinical research trial, many years are spent testing medications in a laboratory to determine the medication’s safety and usefulness. That means every medication you’ve ever received went through this same process.
A study sponsor is the pharmaceutical company, research institution, or other health organization that funds a clinical research study and designs its protocol. Every trial is sponsored by one of these organizations.
A clinical investigator is a medical researcher in charge of carrying out a clinical research study’s agenda. This person is usually a doctor or pharmacist, but can be a nurse or other health care professional. He or she follows a carefully designed and detailed study plan created by the study sponsor.
The clinical research coordinator is a health care professional who, under the supervision of the clinical investigator, controls and maintains all research documents to the, coordinates all the tests and procedures for the study, and schedules and implements the study visit requirements.
For more information on clinical trials, check out our frequently asked questions page where you’ll be able to get the in depth answers you’re looking for.
Rochester Clinical Research works directly with sponsors, and with the Clinical Research Organizations (CROs) they sometimes hire to conduct clinical trials and provide other drug development services. We like to use the word partner for the sponsors and CROs with whom we work. Find out more on the Partner area of our website.