About Clinical Trials
You may have heard the term “clinical trial.” But what exactly is a clinical trial? Have you considered participating in one? Here’s what you should know.
Clinical trials are research studies involving human volunteers to evaluate medical products like medications, vaccines, or devices for safety and effectiveness. These studies may also show which medical products or therapies work best for people with certain illnesses or for certain groups of people.
Clinical trials may compare a new medical product or therapy to a standard approach, to a placebo that contains no active ingredients, or to no medical product or therapy.
Every clinical trial is led by a principal investigator, who is often a medical doctor. Clinical trials also have research teams that may include doctors, nurses, social workers, and other health care professionals.
Clinical trials can be sponsored by organizations (such as a pharmaceutical company), federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers).
The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other federally or industry-funded research sites.
Clinical trials may take weeks or years, depending on what is being studied. Participants are told how long the study will last before they enroll.
Clinical trials have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol (study plan).
The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, medical conditions, and other information. This helps to reduce the variation within the trial and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.
Your study records are typically confidential and can generally only be seen by the research team and health care provider. Every clinical trial is reviewed by an independent Institutional Review Board (IRB) that provides oversight during the clinical trial. IRBs ensure the safety and protection of patients—including their personal medical information.
- Participation is always voluntary — you can leave a study whenever you want.
- Your safety is a priority. Researchers must follow detailed protocols and safety requirements to make each trial as safe as possible and ensure an acceptable balance of risks and benefits.
- The study will be explained to you in an informed consent process before you agree to join.
About Research Participation
Department of Health and Human Services
Office for Human Research Protections
Food and Drug Administration
Office of Minority Health and Health Equity
Clinical Trials: What Patients Need to Know
FDA's Office of Patient Affairs
Conducting Clinical Trials
FDA's Center for Drug Evaluation and Research
NIH Clinical Research Trials and You
National Institutes of Health
Joining a Research Study
Department of Veteran’s Affairs
Office of Research and Development
About Lupus Trials
Lupus Research Alliance