What are clinical trials?
- Clinical trials are an essential part of drug development.
- Clinical trials are designed to evaluate the safety and potential benefits of an investigational medicine for individuals living with a particular disease or condition.
- Clinical trials are conducted in distinct phases to ensure safety first, and then assessment of potential benefits.
Why are clinical trials necessary?
- Clinical research is the primary way to determine if an investigational medicine is safe and effective.
- Clinical trials are conducted to the standards set by the laws and regulations of the country in which the research is conducted. For example, the United States Food and Drug Administration sets the guidelines for clinical trials in the U.S. and determines if an investigational medicine will receive marketing approval as a new drug.
How will a clinical trial impact my condition and life?
- Clinical trials provide the opportunity to access the very latest experimental treatments, after they have been tested and deemed to be safe for use in people.
- Participation in a clinical trial is vital in furthering research on your disease and potential additional treatment options. The information from clinical research helps your doctors understand your disease better. This type of research also helps your doctors evaluate new treatment options that may be safer and more effective for you.
Are clinical trials safe?
- Patient safety is the number one priority of a clinical trial. The potential risks of an investigational therapy should be discussed at length with your care team and loved ones.
- Independent experts in your disease routinely review data from the clinical trial to ensure the safety of trial participants.
If I join a clinical trial, will I stop my regular treatment?
- Enrolling in a clinical trial does not mean foregoing any treatments or procedures your doctor may prescribe. You will continue to receive the best available treatment for your disease.
Why should I be interested in participating in a clinical trial?
- By participating in a clinical trial, you play an invaluable role in bringing new medicines to market that could one day be broadly available to all patients living with the same disease.