Is my study observational or interventional?
A biomedical or behavioral research study of human subjects
Human Subject designed
to assess risk factors for disease development or progression,
assess natural history of risk factors or disease, identify
variations based on geographic or personal characteristics
(such as race/ethnicity or gender), track temporal trends,
or describe patterns of clinical care and treatment in absence
of specific study-mandated interventions.
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102
and full 45 CFR 46
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
For purposes of reviewing grant
Grant applications and contract
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Contract proposals submitted
to the NIH, a clinical trial is operationally defined as a prospective biomedical
or behavioral research study of human subjects that is designed to answer specific
questions about biomedical (drugs, treatments, devices, or new ways of using
known drugs, treatments, or devices) or behavioral interventions.
award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition
Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy
Management and Policy (OAMP) web site provides additional information
Clinical trials are used to determine whether new biomedical or behavioral interventions
are safe, efficacious and effective. Clinical trials of experimental drug, treatment,
device or behavioral intervention may proceed through four phases:
- Phase I
Phase I Clinical Trial
testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
- Phase II
Phase II Clinical Trial
study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
- Phase III
Phase III (see also NIH-Defined Phase III Clinical Trial
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
Clinical Trial )
A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I , Phase II , Phase III , Phase III(as defined by NIH)
Phase III(as defined by NIH)
is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
, Phase IV
Phase IV Clinical Trial
studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.
- Phase IV
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov