Terms and Definitions

Basic research

done in the laboratory, basic research involves studying how cells work, how they communicate, how they know what to do, and what conditions and drugs make their functions more or less efficient. Scientists who conduct basic research test new treatments in animals to find out if they might be helpful or harmful to people.

Clinical research

Treatments with the most promising laboratory results move from laboratory and animal studies into the clinical trial stage. In clinical trials, scientists apply their discoveries to humans, testing new drugs, devices, or innovative therapies in selected patients. Carefully conducted clinical trials are the safest way to evaluate potential medical treatments, assessing their effectiveness and potential risks.

Double-blind trials

trials in which neither the patient nor the researcher knows if the patient is receiving the treatment or the placebo.

Exclusion criteria

Factors that do not allow someone to participate in a clinical trial.

IDE

Investigational Device Exemption—permission granted by the Food and Drug Administration to use a new medical device during a clinical trial.

Inclusion criteria

The factors that allow someone to participate in a clinical trial.

IRB

Institutional Review Board, an independent committee of physicians, statisticians, community advocates, and others. The IRB is charged with ensuring that all clinical trials within a given medical institution are ethical and that the rights of the participants in those trials are protected.

Open label studies

studies in which both the patient and the researcher know that the patient is receiving the treatment and not the placebo.

Placebo

an inactive substance or "dummy" treatment.

Prospective trials

trials in which patients are identified and then observed over time.

Randomized trials

trials in which patients are arbitrarily grouped into (typically) a treatment group and a control group (also called a placebo group). The control group receives either the current standard treatment or no treatment at all. The results of the control group are then compared with those of the treatment group.

Translational research

the evolution of basic research into therapies for patients. Translational research involves identifying drugs, devices, or treatments that hold promise; funding and conducting the development; and transitioning the therapy to clinical research.