Frequently Asked Questions
What You Need To Know About Clinical Research Participation
What is a clinical trial?
A clinical trial, also known as a medical research study, is a carefully designed test of medicines and treatment options under the supervision of a physician and other research professionals. These studies rely on people, also known as study participants, who try the new medicine or treatment. Any participation is voluntary. The medicine 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. Sometimes the medicine or treatment is currently available but is being tested for a new disease, new doses or unique 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, regulated by the Office for Human Research Protections (OHRP), responsible for protecting the study participants and making sure that studies comply with laws. IRBs are usually made up of doctors, scientists, religious figures and other non-medical people in the community. In addition, every study participant is closely monitored with medical tests and exams before, during and after the clinical trial.
Why should I participate in a clinical trial?
As a participant in a clinical trial, you help in the possible development of a new medicine or treatment that may offer better care or a cure for life-threatening and chronic diseases. 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. Whatever your reason, be sure to make an informed decision about participating.
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.
What should I expect?
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. All this information will be provided in writing in what’s called an “Informed Consent Form,” which you must sign before participating. 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 member 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 may 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.
What are the risks?
Sometimes, participants in one study group will receive the study medicine while others receive a placebo. A placebo looks like the study medicine but has no medical effect. In many studies it is required that the participant or the study physician be “blinded,” neither knowing whether the study medicine or placebo is being received. Other trials are “open label,” meaning that participants know what they are taking. Another risk is that some medications being tested can have serious side effects. Because some of the medications being tested are new, the side effects are sometimes unknown. In some clinical trials the treatment, office visits and all tests are free. In most clinical trials the medicine is free, but you or your insurance may be billed for tests and office visits. Before you are enrolled in the study, you should receive information from your physician or other research professional about your financial risks.
What happens after the study?
After a study is complete, participants may return to their previous healthcare provider and/or medications. If the drug remains in development, the pharmaceutical company may or may not continue to provide the study medication to patients who are responding well. At this point, 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 the FDA has approved a drug, 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.
Clinical Trials 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.
To view a complete listing of open trials, visit SCRI's clinical trials search page.
About TriStar Sarah Cannon
