A clinical study (also called a clinical trial) is a research project that tests new treatments, medicines, or procedures on people to find out if they are safe and effective. Studies are a key part of medical advances and are used to develop new ways to prevent, detect, or treat diseases and conditions.
Clinical studies evaluate different kinds of therapies such as:
- New drugs, combinations of drugs, or new ways to use existing drugs
- Researchers might create a new medicine to help people with diabetes, test a mix of medicines to fight cancer better, or find new uses for existing drugs, like using a blood pressure pill to help with anxiety.
- New medical devices
- An example of this is a brain stimulation device that helps treat epilepsy.
- New surgical procedures
- This could include new, non-invasive procedures, like methods to fix heart valves without the need for major surgery.
- New ways to prevent health conditions or find diseases early
- For example, scientists might develop vaccines to prevent illnesses or create blood tests that can spot cancer earlier.
- New behavioral interventions to improve mental health
- This could include new types of therapy that help with depression.
- New ways to improve quality of life for people with chronic or acute illnesses
- An example is an app that helps people with diabetes keep track of their blood sugar.
There are typically four phases of clinical studies, and during each phase, researchers must follow strict rules to keep participants safe. Researchers carefully collect and analyze data to understand the results. Multiple phases help researchers think through potential treatment benefits and any risks.
Phase I
- The first stage of testing a new study drug in people focuses on safety and finding the right dose. In this phase, researchers usually work with a small group of healthy volunteers or people who have the condition the drug is meant to treat. This stage can last for several months.
- Example: A study administers a new diabetes drug to a small group of healthy volunteers to determine the highest safe dose.
Phase II
- The second stage is where the treatment is tested on a larger group of people to see how well it works and to check its safety again. This phase can last from several months to up to two years. In Phase II studies, researchers often use placebos, which are inactive substances (such as a sugar pill), to compare results.
- Example: The diabetes drug from Phase I is given to patients with diabetes to evaluate how well it increases insulin and to identify any side effects.
Phase III
- The third stage includes even more participants and focuses on confirming how well the treatment works for people with the condition. Researchers also watch for any side effects and compare them to standard treatments. This phase can last anywhere from one to four years.
- Example: The diabetes drug is tested against standard diabetes treatments to see if it provides better results or fewer side effects.
Phase IV
- This phase happens after the treatment has been approved and is available to the public. During this phase, researchers watch for long-term effects and gather more information about how well the treatment works for people in the general population who use it.
In the end, clinical studies decide if a new treatment is safe and effective for people to use. If you're interested in participating in a clinical study, view the Featured Studies actively looking for participants!
