Clinical studies are research studies where patients, doctors, and researchers work together to learn if an investigational drug, device, or procedure is safe, how it works in the body, and if it works to treat a specific disease. Investigational means that regulatory authorities, such as the FDA in the US or the EMA in Europe, have not yet reviewed it for use for a particular condition, disease, or patient population.
Clinical studies take place in different phases of research. Each is designed to answer specific questions about safety, the amount of the investigational drug (dosage), and the effectiveness of the treatment.
A small group of participants helps researchers understand how a new treatment works in the body and identify safe dosage levels.
A larger group of participants helps test how well the treatment works, with safety continually monitored.
This stage confirms effectiveness, monitors side effects, and compares the new treatment to existing standard treatments in an even larger group of people.
The Redwood Study is in this phase.
Finally, upon regulatory agency approval, the new treatment’s long-term safety and effectiveness in real-world use are studied.
Clinical research helps doctors and scientists learn more about diseases and how to treat them. It can lead to new medicines, better treatments, and improved patient care. By participating in research studies, people help advance medical knowledge that may benefit others in the future.
People choose to participate in clinical research studies for many reasons. Some want to help others by advancing knowledge about a disease and potential treatments. Others are interested in access to investigational treatments or the extra care, monitoring, and tests provided by specialized study doctors and nurses.
Clinical studies follow strict rules to protect the people who take part. Doctors and nurses carefully monitor participants and perform tests to monitor safety. While every study carries some risks, researchers work to reduce them and provide support throughout the study.