Clinical Trials 101
Your interactive guide to understanding medical research, patient safety, and how you can help change the future of medicine.
What is a Clinical Trial?
A clinical trial is a carefully designed research study involving human volunteers. It is the final and most crucial step in determining if a new medical treatment, device, or therapy is safe and effective.
Without clinical trials, medical breakthroughs would be impossible. They are how we discover new ways to prevent, detect, and treat diseases.
Without clinical trials, medical breakthroughs would be impossible. They are how we discover new ways to prevent, detect, and treat diseases.
What is an IRB?
IRB stands for Institutional Review Board. It is an independent committee made up of doctors, scientists, ethicists, and community members.
Their only job is to protect you. Before any trial can begin, the IRB must thoroughly review the study plan to ensure that the rights, safety, and well-being of the volunteers are fully protected and that the risks are minimized.
Their only job is to protect you. Before any trial can begin, the IRB must thoroughly review the study plan to ensure that the rights, safety, and well-being of the volunteers are fully protected and that the risks are minimized.
The 4 Phases of Clinical Trials
Treatments must pass through strict, step-by-step phases before being approved for the general public:
Phase 1
Tests the treatment in a very small group of healthy volunteers to check for safety and find the right dosage.
Phase 2
Expands the study to a larger group of people who actually have the condition to see if the treatment works.
Phase 3
Compares the new treatment to the current standard of care in thousands of people to confirm its effectiveness.
Phase 4
Ongoing monitoring that occurs even after the FDA has approved the treatment for public use.
What are the benefits to society?
Every modern medicine sitting in your pharmacy today exists because a volunteer stepped forward yesterday.
By participating in a clinical trial, you are actively helping researchers unlock potential cures, improve healthcare standards, and leave a significantly healthier world for future generations. You become a partner in scientific discovery.
By participating in a clinical trial, you are actively helping researchers unlock potential cures, improve healthcare standards, and leave a significantly healthier world for future generations. You become a partner in scientific discovery.
Is my medical data safe?
Absolutely. Your privacy is protected by strict federal laws, including HIPAA.
When you participate in a trial, your personal identity is typically hidden. Your name is replaced with a unique, randomized code so researchers can analyze your health data without ever knowing exactly who you are.
When you participate in a trial, your personal identity is typically hidden. Your name is replaced with a unique, randomized code so researchers can analyze your health data without ever knowing exactly who you are.
Can I leave a trial if I change my mind?
Yes. Participation in any clinical trial is 100% voluntary.
You have the right to leave a study at any time, for any reason whatsoever. Leaving a trial will never affect your access to your regular, everyday medical care. You are always in control.
You have the right to leave a study at any time, for any reason whatsoever. Leaving a trial will never affect your access to your regular, everyday medical care. You are always in control.