Clinical trials are research studies using volunteers (also called participants) that aim to determine whether a medical strategy, treatment, or device is safe for use or consumption by humans.
These studies may also present which medical approaches prove most effective for specific conditions or groups of people and, as a result, add to medical knowledge. Today’s clinical trials will lead to new standards of care in the future.
How Clinical Trials Work
Clinical trials play a critical role in the development of new treatments and are the culmination of years—often decades—of work done by researchers to find ways to slow, treat, or even cure diseases like Alzheimer’s, macular degeneration, and glaucoma. Unlike earlier phases of research, clinical trials are completely dependent on the volunteer participation of patients and others who are personally invested in seeing new treatments become available.
Starting in the Lab
The process starts in the laboratory where it takes a number of years of sifting through a thousand potential treatments to find a handful.
Clinical Trial Phases
Phase 1 - Ensures that the treatment is safe in humans and determines how and where it distributes within the body.
Phase 2 - Determines the right dosage and effectiveness in treating that particular disease.
Phase 3 - Determines whether the treatment* would be safe and effective for a wide variety of people
FDA Approval Process
The Food and Drug Administration (FDA) only approves drugs that they determine to have solid evidence of safety and effectiveness for public use or consumption.
Deciding to Enroll
People with a medical condition or healthy individuals may consider participating in clinical trials. Each trial has its own protocol, or set of guidelines, and volunteers first must meet certain criteria to qualify for enrollment.
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