By participating in the SOLSTICE clinical research study, you help advance the understanding of CMV infections in transplant recipients, and assist with the approval of a new treatment option. The information gathered (including blood sampling and the other tests completed) may help other transplant recipients with CMV infection in the future.
Those who qualify for this study, whether they are assigned to receive the investigational drug—maribavir—or the study doctor’s treatment of choice, will receive study-related medical care at no cost to them.
Like all clinical research studies, there is a certain amount of risk. The study doctor will speak to you about any possible side effects that you or your child might experience. Since the drug is still being studied, there may also be side effects that we don’t already know about, which can happen when the investigational drug is given alone or in combination with other drugs. It is important that you report any symptoms or health problems to the study doctor, whether or not you think these problems are related to the investigational drug. Your involvement is completely voluntary and you may choose to leave the study at any time.
A clinical research study is a research project done with human participants to learn more about an investigational drug or treatment. In a clinical research study, the participants get the treatment under the supervision of a doctor and other research professionals. The word "investigational" means the treatment is not approved for use by the US Food and Drug Administration (FDA), Health Canada, or health agencies of the European Union.
By volunteering, people help doctors find new treatments and ways to provide care. As a study goes on, the doctor and researchers gather information to see whether the investigational treatment:
All of these results are important because they advance medical knowledge and help improve patient care.
After a clinical research study is finished, all of the information is collected and analyzed to help determine the safety and effectiveness of the drug. Your doctor or healthcare provider will determine which treatment options are appropriate, after you complete a clinical research study.
Government regulatory agencies review the study results, and if they determine that the investigational drug is a safe and effective treatment, they may approve it for use by the public.
Clinical research studies are regulated, following rules set by government health authorities. The clinical research study will follow a protocol, which is a detailed study plan the researchers will follow. Each clinical research study must also be reviewed by an institutional review board (IRB) or ethics committee (EC). IRBs and ECs are groups of people who help protect the rights and welfare of people participating in research studies. They are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people. Your privacy will also be protected. The research team cannot tell anyone that you are participating in a clinical 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 based on the study.
Yes, you have the right to leave a clinical research study at any time. When you want to leave, tell the doctor or research team and explain your reasons for leaving.
Each study phase is a different step in the clinical research process, and with each phase the researchers learn more about the treatment.
Phase 1 studies are the first step in testing investigational drugs and treatments. In these studies, researchers often give the drug or treatment to a small group of healthy participants to test the safety of different doses; determine how the drug should be given (eg, injected under the skin vs into a vein); and watch closely for any side effects.
Phase 2 studies usually focus on a particular medical condition. In these studies, researchers give the investigational drug or treatment to a larger group of participants, including patients with the given medical condition. The researchers watch the participants to see if the treatment 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 government regulatory agencies. In these studies, participants with a given medical condition may receive the investigational treatment, a placebo (a look-alike that contains no active medication), and/or another commonly used treatment. Researchers compare the treatments to:
The SOLSTICE study is a phase 3 clinical research study designed to explore an investigational drug—maribavir—against currently available treatments. Participants will be treated with either the investigational drug or the study doctor’s treatment of choice.
Phase 4 studies are done after the drug or treatment has been approved by regulatory agencies and marketed for public use. These studies continue testing the drug or treatment to collect additional information about its effectiveness and gather data on any side effects associated with long-term use.