Glossary

Strategies to keep participants engaged and active throughout the duration of a clinical trial.

Increasing doses in a trial to determine the maximum tolerated dose of a treatment.

A tool for participants to record symptoms, treatment schedules, or other trial-related information.

Providing an experimental treatment to a patient outside of a clinical trial, often in life-threatening situations.

Findings analyzed during a trial before its completion to evaluate progress or safety.

Groups such as children, pregnant women, or the elderly that require additional protections in clinical trials.

A stage in the trial process, ranging from Phase 1 (safety) to Phase 4 (post-marketing).

Issues that may prevent participants from following trial protocols.

Authorization from the U.S. Food and Drug Administration for a drug or device to be marketed.

A measure used to determine if the treatment has the desired effect in a clinical trial.

The process of proving that a biomarker reliably measures a specific biological process or condition.

A document outlining how potential risks will be identified, assessed, and mitigated during a clinical trial.

The researcher conducting and overseeing the clinical trial at a specific site.

The process of identifying and enrolling participants in a clinical trial.