About Clinical Trials - What to Expect
Every clinical trial is different, and each is closely supervised by the doctors at The Jackson Clinic. Your doctor will let you know exactly what to expect when participating in a clinical trial and will monitor your health closely. Clinical trials produce the best data available for health care decision making.
What To Expect
- The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.
- Clinical trials will have specific rules that must be followed closely. You may have more tests and medical exams than you would if you were not taking part in a trial.
- The ethical and legal codes that govern a medical practice also apply to clinical trials. Every participant in a clinical trial is treated with dignity and respect.
- The trial may involve a medication that is already FDA approved, but is being studied in order to become approved for a new disease or illness. In some cases, you may be provided access to medication or devices that are not yet available by prescription.
- You may be asked to keep a log about your health or fill out forms about how you feel.
Eligibility To Participate
A clinical trial often looks for specific patients that fit the criteria of the study to take part in the research—that is, who is eligible. Eligibility restrictions ensure that new approaches are tested on similar groups of people. This makes it clear to whom a clinical trial's results apply.
Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether the patient has had certain treatments or has other health problems. Some trials enroll healthy people to test new approaches to prevention, diagnosis, or screening.
The Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines and devices before any clinical trials are done. They check to make sure that the proposed studies have proper informed consent and protection. Informed consent is the process of giving clinical trial participants all of the facts about a particular trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have.
Taking part in a clinical trial is your decision. Before you can enroll in a clinical trial, you will be given an informed consent form that presents the key facts of the study. If you agree to take part in the trial, you'll be asked to sign this form.
The informed consent document is not a contract. You have the right to withdraw from a study at any time.
Clinical trials do have some down sides. The new strategies and treatments being studied may not always turn out to better than current standard care. A new treatment may have side effects or risks that doctors don't know about or expect. Even if a new approach benefits some participants, it may not work for you.
Taking part in a clinical trial can have many benefits. For example, you may gain access to new treatments before they're available to the general public. If a new treatment is proven to work and you're in the group getting it, you might be among the first to benefit.
People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others.