Clinical Trial Summary
A clinical trial is a medical research study that tests a medicine or treatment to see if it is safe and if it works. Before you participate in a study, you must be given complete information including possible side effects, risks and benefits. You must sign an Informed Consent Form before participating in the study. You can leave the study at any time.
A clinical trial is also known as a medical research study. It is a carefully designed test of medicines, devices and treatment options under the supervision of a physician. These studies rely on people, referred to as “study participants”, to try the new medicine, device or treatment. Any participation is voluntary. The medicine, device or treatment may be referred to as “investigational” because it is being tested to determine how well it works and/or what side effects it may cause. For this reason, every study participant is closely monitored with medical tests and exams before, during and after the clinical trial. In some clinical trials, the medicine being studied is already used by doctors but is in a clinical trial to test it for a new disease, new dose or in new combinations. Clinical trials must follow strict rules set by the Food and Drug Administration (FDA), and each trial must be approved by an Institutional Review Board (IRB). An IRB is a group of people responsible for protecting the study participants and making sure that the study complies with the law. IRBs are usually made up of doctors, scientists and other non-medical community members.
Individuals participate in clinical trials for a variety of reasons including access to new treatments before they are widely available, advancement of science, or improved medical care. Study participants can benefit greatly from clinical trials by receiving access to the most promising investigational treatments available. This helps in the possible development of a new medicine or treatment that may offer better care or a cure for life-threatening and chronic diseases. Whatever your reason for participating, you can be sure you will receive quality care while on a clinical trial.
Before you enroll in a study, a detailed description of the study as well as any possible risks and benefits of participating will be discussed with you. You should also receive information about whether any financial obligations are involved in your participation in the study. All this information will be provided in writing in what is called an “Informed Consent Form.” By signing this form, you are agreeing to participate in the study. A copy of the form will be provided to you for your own personal reference. You may receive a physical exam, and your medical history will be reviewed. Once you are enrolled in the study, you should feel free to discuss your medical care with the physician or any research staff at any time during the course of the trial. It is important that you take all the medication as prescribed and keep all scheduled visits. It is also important for you to answer questions regarding how you feel or whether you have been taking the medication at the scheduled times. Your study physician needs to record any symptoms, no matter how minor they seem. If you miss taking a dose of the medication or do not take it on schedule, tell your physician or research staff. As a study participant, you have the right to leave the study and/or contact the study’s IRB representative at any time.
The Informed Consent Form will list the side effects of the study medicine. Because some of the medications being tested are new, some side effects may still be unknown. Some medications being tested can have serious side effects.
Why are clinical trials important?
Data collected during a clinical trial can ultimately lead to a new drug being approved by the FDA and help in developing medications that are safer, more effective and work better than any drugs before them.
After the study treatment is complete, some participants will be followed every few months for many years to see how they are doing. If the participant changes to another healthcare provider, then the research staff may contact the participant over the phone. All of the information collected is analyzed to help determine the study drug’s safety, effectiveness and side effects. FDA medical advisors and specialists closely review this data before considering any new drug for approval. After a drug has been approved by the FDA, studies continue to compare the new drug with other drugs already on the market. Other studies may research whether it can be administered to children or special populations, its long-term effectiveness and impact on the quality of life. For more information regarding clinical trials, ask your doctor, call Ask Sarah at 1-877-My1SCRI (1-877-691-7274) or send an email to CVResearch@SCResearch.net.