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Clinical Research FAQ

Here are some common questions and answers about clinical research studies.

A clinical research study is a research project done with human patients to find out if new medications, treatments, or devices are safe, tolerable, and effective. In a clinical research study, the participants get an investigational treatment 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 research study goes on, the doctor and researchers gather more and more information about the investigational treatment. The research study results may show that the investigational treatment 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 review the study results and feel that the investigational treatment is safe and effective, they may approve it for use by the public.

Each research study phase is a different step in the clinical research process, and with each phase the researchers learn more about the investigational treatment.

Phase 1

Research studies are the first step in testing new drugs and treatments. In these research studies, researchers often give the investigational drug or treatment to a small group of patients to test the safety of different doses, determine how it should be given, and watch for any side effects.

Phase 2

Research studies usually focus on a particular medical condition. In these research studies, researchers give the investigational study drug or treatment to a larger group of patients, including patients with the given medical condition. The researchers watch the participants to see if the investigational treatment is effective, learn more about any side effects, and further test its safety.

Phase 3

Research studies are usually the last step before a drug is approved (or not approved) for the public by regulatory agencies. In these research studies, researchers give the new investigational treatment or sometimes another commonly used treatment to patients with the given medical condition. Researchers compare the treatments, confirm the new investigational treatment’s effectiveness, monitor its side effects, and collect information that will allow the drug or treatment to be used safely.

Phase 4

Research studies are done after the drug or treatment has been approved by regulatory agencies and marketed for public use. These research studies continue testing the drug or treatment to collect 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 your treatment options after you complete a research study.

In the USA, clinical research studies follow strict rules set by the US Food and Drug Administration.

Each research study must also be reviewed by an institutional review board (IRB). IRBs are groups of people who help protect the rights and welfare of people participating in research studies. IRBs are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people.

Your privacy will also 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 research study will be kept confidential, and your name won’t be listed in any reports based on the research 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 and explain your reasons for leaving. If you decide to leave the Thales Research Study after receiving the transfusion, that will mean you’ll forgo monitoring from research study doctors and follow-up care.

Click here to find a doctor participating in the Thales Research Study.