What is a clinical trial? Why do we need them?
A clinical trial is a research study to determine if new investigational medical devices, medications, tests, or treatments are safe and effective. Clinical trials are performed according to government regulations that help protect the safety and rights of study participants. Beyond learning about a specific treatment, these research studies contribute to the overall body of knowledge for any given disease.
How do clinical trials work?
- Researchers set a specific duration for the trial, during which participants will receive either the experimental treatment being studied or an alternate treatment. This will be a placebo, i.e., a “sugar pill” or a treatment already approved by the U.S. Food and Drug Administration (FDA).
- The strongest clinical trials are double-blind, where both participants and researchers are unaware of which treatment is being taken. This helps prevent bias.
- Many measurements are taken during the treatment period. These include tests of physical function and scans to assess treatment effectiveness for the disease in question.
- Once this period is complete, the researchers discover which subjects were getting which treatments.
- By analyzing their measurements, they can tell what effects, if any, the treatment had.
What are the phases of a clinical trial?
Clinical trials take part in several phases, including a preclinical phase. Each phase increases the number of participants and their exposure to the treatment in question. Once in Phase III, the new treatment is compared to the standard-of-care treatment in order to assess effectiveness and side effects. In the final phase, Phase IV, the trial tests the new treatment approved by the FDA, in order to better understand rare or long-lasting side effects and safety.
Why should I participate?
- You may get a new experimental medication, procedure, or treatment before it’s made available to the general public.
- You will be provided with study-related medical care, more frequent check-ups, and reimbursement for study-related expenses.
- You have the opportunity to better understand the disease and contribute information that may be helpful in developing new therapies in the future.
This is an experimental medication that is not approved by the FDA or any regulatory authorities for any use outside of clinical trials. Its safety and efficacy have not been demonstrated. Consult with your doctor before participating.