1. What is a clinical trial?
Clinical trials are structured and well-designed studies that collect data about new treatments for diseases and disorders. Most of the time the studies are about medications, but clinical trials can also test other things, such as stem cell therapies, surgical techniques, tests for diagnosis, medical devices, and more. In particular, clinical trials focus on the effect and safety of an experimental therapy in humans. Tests that are conducted first in the laboratory on animals are referred to as “pre-clinical” research.
2. Why do we need clinical trials?
Clinical trials are needed before medical treatments can be approved by government organizations, such as the US Food and Drug Administration (FDA). Without clinical trials, doctors and other prescribing healthcare providers (such as nurse practitioners or physician’s assistants) cannot prescribe medications or recommend other medical treatments. These studies are needed to understand two important types of information: that the treatment is effective (also called efficacious), and that the treatment is safe for human use.
3. How do clinical trials work?
Usually, effectiveness is compared versus a placebo (sugar pill with no medication in it), or another drug already approved for use. A comparison is needed to show that the medication works and is safe. Researchers will design the clinical trial for a specific period of time, during which the people participating will either get the treatment or the comparison treatment. Many parameters are closely monitored.