A clinical research study is a research done with human volunteers, to find out if new investigational medications, treatments, or devices are both safe and effective. In a clinical research study, the participants get an investigational product under the supervision of a doctor and other research professionals. The word “investigational” means it isn’t available or approved yet for public use.
By volunteering, people help doctors find new and improved treatments and better ways to provide care. As a study goes on, the doctor and researchers gather more and more information about the investigational product. The study results may show that the investigational product improves patient outcomes, offers no benefit to patients, or causes patients unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care.
If regulatory agencies such as the FDA review the study results and see evidence that the investigational product is safe and effective, they may approve it for use by the public.
Each study phase is a different step in the clinical research process, and with each phase the researchers learn more about the study product.
Phase 1 studies are the first step in testing new investigational drugs and treatments. In these studies, researchers often give the investigational drug or treatment to a small group of healthy volunteers / cancer patients (for cancer drugs) to test the safety of different doses, determine how it should be given, and watch closely for any side effects.
Phase 2 studies usually focus on a particular medical condition. In these studies, researchers give the study drug or treatment to a larger group of volunteers, including only patients with the given medical condition. The researchers watch the participants to see if the study drug is effective, learn more about any side effects, and further test its safety.
Phase 3 studies are usually the last step before a drug is approved (or not approved) for the public by regulatory agencies. In these studies, researchers give the study drug or sometimes another commonly used treatment to volunteers with the given medical condition. Researchers compare the treatments, confirm the study drug’s effectiveness, monitor its side effects, and collect information that will allow the treatment to be used safely.
Phase 4 studies are done after the treatment has been approved by the FDA and marketed for public use. These studies continue testing the treatment to collect additional information about its effect and gather data on any side effects associated with long-term use.
After a clinical research study is finished, all of the information is collected and analyzed, to help determine the medication’s safety, effectiveness, and side effects.
Please talk to your doctor or healthcare provider to find out more about your treatment options after you complete a study.
Clinical research studies are regulated, following rules set by health authorities. The research study will follow a protocol, which is a detailed study plan explaining what researchers will do in the study.
Each research study must also be reviewed by an institutional review board (IRB). An IRB is a group of people who help protect the rights and welfare of people participating in research studies. The group is usually made up of doctors, scientists, religious representatives, and other medical and non-medical people.
Your privacy will be protected. The research team can’t tell anyone that you’re participating in a research study without your permission. All of the information collected during the study will be kept confidential, and your name won’t be listed in any reports or publication based on the study.
Yes, you have the right to leave a research study at any time. If you want to leave, tell the doctor or research team.