Every approved medicine is available because people volunteered to participate in a clinical trial.
Patients and healthy volunteers make priceless contributions to advances in medicine. They help us understand diseases and discover lifesaving and life-enhancing treatments.
A clinical trial is a research study. It is designed to test if a medicine, vaccine, or medical device is effective and safe. A clinical trial may take place at a hospital, doctors’ office, or clinical research center. It is conducted by doctors, nurses, and other healthcare team members.
Most ideas for a new medicine or treatment start in a laboratory. This is called "preclinical" research. Scientists research a new product in the lab, sometimes over many years, before testing it in people.
Only the most promising treatments go on to be studied, or investigated, in human beings. People volunteer to test these investigational treatments in clinical trials. These studies are designed to find answers to very specific health questions.
Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include:
Clinical trials can take many years to develop and complete. Each one is designed differently. In general,
Researchers plan studies under specific conditions considering many different factors like age, gender, the type and stage of the disease, any previous treatments a patient received, and whether they have other medical conditions.
To find out if you might qualify for a study, ask about:
Before you decide to participate in a clinical trial, you will go through a process called "informed consent". This is designed to help you learn the facts about the clinical trial before deciding whether to participate.
You will be given detailed information about the study. This includes:
Once you understand this information, you may decide to participate. At that point, you will be asked to give your consent. You will need to sign an “informed consent” document to confirm your decision.
Then, you will go through a screening process to find out if you qualify to participate in the trial, based on the inclusion and exclusion criteria.
The screening process for a clinical trial is different for each study. It often involves a visit to the research facility (for example, a doctor's office or hospital), and an assessment by medical staff. During screening, you might find out that you are not able to enroll in the study.
If screening shows that you can enroll, the clinical trial staff will walk you through the enrollment process and talk about logistics, like scheduling future visits.
An informed consent is designed to protect you. It is not a contract. You have a right to:
U.S. Food and Drug Administration. Inside Clinical Trials: Testing Medical Products in People.
MAT-US-2105222-v1.0-10/2021 | Last update October 2021
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