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Clinical Research

Focuses on improving knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care.

Clinical Trials

What is ClinicalTrials.gov and who uses it?

ClinicalTrials.gov is a website and online database of clinical research studiesand information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals. The U.S. government does not review or approve the safety and science of all studies listed on this website.

ClinicalTrials.gov:

  • Relies on sponsors or investigators to submit and update information about studies
  • Lists up-to-date information on clinical research studies and their results with new studies added almost every day
  • Includes studies that take place in all 50 states and over 200 countries
  • Supports laws, regulations, and policies that require sponsors and investigators to publicly share information about clinical trials, including results

Does the U.S. Government approve all studies listed in the ClinicalTrials.gov database?

No. The U.S. government does not review or approve the safety and science of all studies listed in the ClinicalTrials.gov database. The National Institutes of Health (NIH) and other U.S. agencies only approve the studies that they fund. U.S. government agencies do not fund all the studies listed on ClinicalTrials.gov.

The National Library of Medicine (NLM) does a limited review of the study information that sponsors and investigators submit to be included in the study record in the ClinicalTrials.gov database. The study sponsor or investigator is responsible for the safety, science and accuracy of any study they list on ClinicalTrials.gov. They are also responsible for ensuring that their study follows all relevant laws and regulations.

What clinical studies can be listed in the ClinicalTrials.gov database?

ClinicalTrials.gov lists studies that involve people, have health-related research questions, and follow ethics review and other health authority rules and laws. The ClinicalTrials.gov database includes these types of studies:

  • Clinical trials: research studies in which researchers assign participants to get one or more interventions (such as a drug, behavior, or medical device) to test what happens in people.
  • Observational studies: research studies in which researchers simply collect information (called data) from participants or look at data that was already collected. The data may be about participants’ health, habits, or environments. In observational studies, researchers do not assign participants to get an intervention. If there is an intervention, participants were already using it as part of their regular health care or daily life.

Learn more about types of clinical research studies on the Learn About Studiespage.