What is a Clinical Trial?
Testing the Safety of Medications & Treatments for Future Generations
You might ask yourself, what is a clinical trial? Clinical trials are medical research studies that involve the participation of volunteers to help scientists understand and develop new ways to prevent, detect, or treat diseases and their symptoms. These investigational treatments may be new drugs, a combination of drugs, new ways to deliver an already marketed drug, or a medical device.
Before a new medication is approved, it must undergo a series of lengthy and rigorous tests, first in the laboratory, then in animals, and ultimately in humans. A new medication or medical device must not only be safe and effective, but in many cases it must also demonstrate a superior benefit when compared to similarly approved products.
What's involved?
When volunteering to participate in a research study, volunteers are screened according to the
specific study for which they are potentially eligible for.
During the screening visit, a Consent form will be reviewed which will explain the expectations, including any known risks of the study, experimental medication, the number of visits, the total length of the study, and all of the expectations and procedures that will be performed during the study.
Once the consent form is understood and signed, screening procedures may start. Once the screening visit is completed, a staff member will notify volunteers if they are eligible to enroll or start participating in the study and provided instructions for continuing.
How are studies conducted?
A clinical study is conducted according to a research plan known as a protocol that has been developed by the pharmaceutical company and reviewed by the FDA along with an Institutional Review Board (IRB) representing the public interest. These agencies monitor the progress of these studies.
The protocol determines:
- The reason for the study
- The number of participants
- The criteria used to determine who is eligible for the study
- A schedule for procedures, tests, drugs and dosages
- The length of the study
- What information will be gathered about the participants
- And much, much more
