Statistical Principles for Clinical Trials - ICH E9

The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of a clinical trial to make the estimate of a treatment effect deviate from its true value.

A specific type of bias that is introduced through deviations in trial/study conduct.

The checking and assessment of data during the period of time between trial completion and the breaking of the blind for the purpose of finalizing the planned analysis.

The extent to which a variable (e.g., a rating scale) measures what it is supposed to measure.

A design technique for retaining the blind when administering supplies in a clinical trial when two treatments are dissimilar in appearance; subjects typically take both dosage forms, but one is active and the other is placebo.

A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol.

A trial with the primary objective of showing that the response of two or more treatments differs by an amount which is clinically unimportant.

The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle.

The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.

A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject.

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment regimen.

The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (e.g., center).

The property of yielding equivalent results when used by different raters on different occasions.

The property of yielding equivalent results when used by the same rater on different occasions.

Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial.

The formal evaluation of the quantitative evidence from two or more trials bearing on the same question.

A clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator.

A trial with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo).

The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.

The __________ of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests, vital signs, clinical adverse events, etc.

The __________ of the medical product represents the degree to which overt adverse effects can be safely endured by the subject.

A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo).

A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible.

An effect attributed to a treatment in a clinical trial. This can be of one treatment or a comparison (or contrast) of two or more treatments.

An event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state.

A statistician who has a combination of education/training and experience sufficient to implement the principles outlined specifically in the ICH E9 Guidelines and be responsible for the statistical aspects of the trial.