What is a clinical trial?
A clinical trial is a medical research study designed to evaluate new medications, vaccines, therapies, diagnostic tests, screenings, or disease prevention. Such clinical studies are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical studies are the safest way to find treatments that work. All new medications and vaccines have come through this FDA-regulated process.
What protections are there for people who participate in a clinical trial?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is a committee of physicians, statisticians, patient advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct such medical research must, by FDA regulation, have an IRB that initially approves and periodically reviews the research.
Who can participate in a clinical trial?
All clinical trials have criteria and guidelines about who can participate in the study. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before enrolling in a clinical trial, a person must qualify for the study. Some research studies seek volunteers with particular illnesses or conditions, while other trials seek healthy volunteers.
Why do people participate in clinical studies?
There can be several reasons. One common reason is that available therapies for a medical condition are only partially effective, or there is no generally accepted therapy. In the case of vaccine studies, many people are focusing on prevention of the disease. Participation might offer the patient a new alternative to treatment before it will be available to the general public. Many people volunteer for participation in clinical studies because they are survivors of a disease, like cancer, and want to do all they can to prevent cancer in others. Many want to contribute to research efforts that may help other patients in the future.
What about costs?
Every study is unique in what will and will not be paid for during the clinical study. Often, studies pay for medications, doctor visits, tests and treatments. Many times stipends are offered to offset for patient's time and travel. Prior to participating in the study, these financial issues should be freely discussed with the study staff.
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