Launched in February 2000, ClinicalTrials.gov is hosted and maintained by the National Library of Medicine at the National Institutes of Health. Sponsors or clinical trials principal investigators are required by law to register their study. Many are interventional studies, which assign a volunteer to an intervention, such as a medical product, behavior, or procedure. Some studies offer expanded access programs that facilitate access to investigational drugs outside of the trials (formerly called compassionate use).

Intended for use by patients, family members, healthcare professionals, researchers, and the public, each individual study record summarizes the study protocol and important details. Some completed study records also present the findings, including a description of participant demographics, outcomes, and adverse events.

Conduct a Search

Use the basic search box as an easy way to start (see sidebar). The advanced search allows you to target your search with very specific criteria, such as eligibility age groups, outcome measures, or study phases. If you are looking for a specific study record, the advanced search may help you to find it more quickly.

Review the Record

The study record heading includes the study’s title, National Clinical Trial identifier number, overall study recruitment status, sponsor, and the source of the information listed. It outlines the study in several subsections:

• Description: a summary of the condition being studied, intervention or treatment used, and study phase
• Design: an overview of the study type, estimated enrollment, how the study is allocated (i.e., randomized or nonrandomized), and blinding, if any
• Arms and interventions: additional details on the different treatment intervention arms or groups, drug dosages, and how long the interventions will last
• Outcome measures: primary and secondary outcome measures used to determine the intervention’s effectiveness
• Eligibility criteria: characteristics that must be shared by all study participants to ensure researchers achieve accurate and meaningful results
• Contacts and locations: individual sites that are conducting the clinical trial, including the institution, research contact, principal investigator, and site-specific recruitment status

Apply the Information to Your Situation

If a patient will only consider enrolling in a trial that ensures they know and receive the investigational agent, a randomized, blinded trial may not be the best match for them. Also, carefully review the eligibility criteria to determine whether your patient meets them. Official eligibility screening is performed only by research staff, and certain clinical results may need to be collected within a defined timeframe. To learn more about the study or to refer a patient for screening, contact the research staff listed in the contacts section.

Participation in a clinical trial is a personal choice for patients, and oncology nurses can provide the education so they can make an informed decision. The study records available on ClinicalTrials.gov are a springboard to start those discussions.