Learn More About Clinical Trials

What is "Primary Purpose"?

The main objective of the intervention(s) being evaluated by the clinical trial.

  • Treatment: One or more interventions are being evaluated for treating a disease, syndrome, or condition.
  • Prevention: One or more interventions are being assessed for preventing the development of a specific disease or health condition.
  • Diagnostic: One or more interventions are being evaluated for identifying a disease or health condition.
  • Supportive Care: One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.
  • Screening: One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor.
  • Health Services Research: One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.
  • Basic Science: One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
  • Device Feasibility: An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
  • Other: None of the other options applies.

What is "Study Type"?

The nature of the investigation or investigational use for which clinical study information is being submitted

  • Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.
  • Observational: Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention.
    • Patient Registry: An observational study that is also considered to be a Patient Registry. This type of study should only be registered once in the Protocol Registration and Results System (PRS), by the sponsor responsible for the primary data collection and analysis.

      Note: The Agency for Healthcare Research and Quality (AHRQ) defines a Patient Registry as including an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, healthcare services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions.
  • Expanded Access: An investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol. (For more information on data requirements for this Study Type, see Expanded Access Data Element Definitions).