end point〔温度や電圧の限界におけるデバイスの振る舞い〕

Endpoints and the plan for their analysis should be prospectively specified in the protocol.〔【出典】ICHガイドライン 〕

＊ Performance characteristics of the biomarker test used, based on retrospective and/or prospective correlation with nonclinical and/or clinical endpoint data.〔【出典】ICHガイドライン 〕

When this design is used, it is desirable to have critical decisions, such as eligibility and endpoint determination or changes in management, made by an observer blinded to treatment assignment.〔【出典】ICHガイドライン 〕

Stratification by age within this category is often unnecessary, but it may be appropriate to stratify patients based on pharmacokinetic and/or efficacy endpoint considerations.〔【出典】ICHガイドライン 〕

The criteria for deciding whether these endpoints have occurred should be well specified, and the timing of measurements should ensure that patients will not remain untreated with an active drug while their disease is poorly controlled.〔【出典】ICHガイドライン 〕

These objectives may be served by exploratory analyses, examining subsets of data and by including multiple endpoints in trials.〔【出典】ICHガイドライン 〕

With care, however, withdrawal for lack of effectiveness can sometimes be used as a study endpoint.〔【出典】ICHガイドライン 〕

In such cases, the need to change treatment becomes a study endpoint.〔【出典】ICHガイドライン 〕

In other situations where a pharmacokinetic approach is not applicable, such as for topically active products, extrapolation of efficacy from one patient population to another may be based on studies that include pharmacodynamic endpoints and/or appropriate alternative assessments.〔【出典】ICHガイドライン 〕

Therefore, when comparing them in a clinical trial, the choice and timing of endpoints may favor one treatment or the other.〔【出典】ICHガイドライン 〕

These procedures can vary from simple random assignment to a selected fixed drug/dose regimen, to some specified titration procedure, to more elaborate response-determined selection procedures, e.g., where dose is titrated upward at intervals until intolerance or some specified endpoint is achieved.〔【出典】ICHガイドライン 〕

Note that it is often possible to have a blinded evaluator carry out endpoint assessment, even if the overall trial is not double-blind.〔【出典】ICHガイドライン 〕

In some cases, it may be useful to have an independent set of reviewers reassess endpoints in the control group and in the test group in a blinded manner according to common criteria.〔【出典】ICHガイドライン 〕

Support may be provided by an analysis of previous studies similar to the present study with respect to important design characteristics （patient selection, study endpoints, duration, dose of active control, concomitant therapy etc.） showing a consistent ability to demonstrate superiority of the active control to placebo.〔【出典】ICHガイドライン 〕

Among aspects of trial design that could unfairly favor one treatment are choice of dose or patient population and selection and timing of endpoints.〔【出典】ICHガイドライン 〕

If the regions are ethnically dissimilar and the medicine is ethnically sensitive but extrinsic factors are generally similar （e.g., medical practice, design and conduct of clinical trials） and the drug class is a familiar one in the new region, a controlled pharmacodynamic study in the new region, using a pharmacologic endpoint that is thought to reflect relevant drug activity （which could be a well-established surrogate endpoint） could provide assurance that the efficacy, safety, dose and dose regimen data developed in the first region are applicable to the new region.〔【出典】ICHガイドライン 〕

A primary endpoint（s） should reflect clinically relevant effects and is typically selected based on the principal objective of the study.〔【出典】ICHガイドライン 〕

incidence of the primary end point

Primary and secondary endpoints and plans for their analyses should be clearly stated （see ICH E9）.〔【出典】ICHガイドライン 〕

primary efficacy end point

primary composite end point

The methods used to make the measurements of the endpoints, both subjective and objective, should be validated and meet appropriate standards for accuracy, precision, reproducibility, reliability, and responsiveness （sensitivity to change over time）.〔【出典】ICHガイドライン 〕

secondary endpoint〔薬効評価などにおける〕

secondary composite end point

Because of the advantages of double-blind designs, this design is likely to be needed and suitable only when it is difficult or impossible to double-blind （e.g., treatments with easily recognized toxicity） and only when there is reasonable confidence that study endpoints are objective and that the results of the trial are unlikely to be influenced by the factors listed in section 1.2.2.〔【出典】ICHガイドライン 〕

If a surrogate end point （a laboratory measurement or physical measurement or sign that is not a direct measure of clinical benefit） was used as a study end point, this should be justified e.g., by reference to clinical data, publications, guidelines or previous actions by regulatory authorities.〔【出典】ICHガイドライン 〕

A surrogate endpoint is an endpoint that is intended to relate to a clinically important outcome but does not in itself measure a clinical benefit.〔【出典】ICHガイドライン 〕

For example, where it is intended that a fixed dose, dose-response study using a clinical endpoint is needed as the bridging study, a short-term pharmacologic endpoint study may be used to choose the dose（s） for the larger （clinical endpoint） study.〔【出典】ICHガイドライン 〕

Important details of the trial design, e.g., study population, concomitant therapy, endpoints, run-in periods, should adhere closely to the design of the trials used to determine that historical evidence of sensitivity to drug effects exists.〔【出典】ICHガイドライン 〕

reliable end-point

Ethical concerns may also direct studies toward less ill subjects or toward examination of short-term endpoints when long-term outcomes are of greater interest.〔【出典】ICHガイドライン 〕

Secondary endpoints assess other drug effects that may or may not be related to the primary endpoint.〔【出典】ICHガイドライン 〕

Depending on the drug and the endpoint studied, pharmacodynamic studies and studies relating drug blood levels to response （PK/PD studies） may be conducted in healthy volunteer subjects or in patients with the target disease.〔【出典】ICHガイドライン 〕

Externally controlled trials are most likely to be persuasive when the study endpoint is objective, when the outcome on treatment is markedly different from that of the external control and a high level of statistical significance for the treatment-control comparison is attained, when the covariates influencing outcome of the disease are well characterized, and when the control closely resembles the study group in all known relevant baseline, treatment （other than study drug）, and observational variables.〔【出典】ICHガイドライン 〕

In many cases, efficacy and safety endpoints are difficult to distinguish, （e.g., deaths in a fatal disease study）.〔【出典】ICHガイドライン 〕

safety end point

objective endpoint

That choice affects the inferences that can be drawn from the trial, the ethical acceptability of the trial, the degree to which bias in conducting and analyzing the study can be minimized, the types of subjects that can be recruited and the pace of recruitment, the kind of endpoints that can be studied, the public and scientific credibility of the results, the acceptability of the results by regulatory authorities, and many other features of the study, its conduct, and its interpretation.〔【出典】ICHガイドライン 〕

In order to provide flexibility for future process improvement, when describing the development of the manufacturing process, it is useful to describe measurement systems that allow monitoring of critical attributes or process end-points.〔【出典】ICHガイドライン 〕

cardiovascular endpoint

If a new, more pharmacologically active, thrombolytic were compared with an older thrombolytic, the more active treatment might look better if the endpoint were mortality, but worse if the endpoint were a composite of mortality and disabling stroke.〔【出典】ICHガイドライン 〕

As with the early-escape design, careful attention should be paid to procedures for monitoring patients and assessing study endpoints to ensure that patients failing on an assigned treatment are identified rapidly.〔【出典】ICHガイドライン 〕

For efficacy, different endpoints may be established for pediatric patients of different ages, and the age groups might not correspond to the categories presented below.〔【出典】ICHガイドライン 〕

Where efficacy studies are needed, it may be necessary to develop, validate, and employ different endpoints for specific age and developmental subgroups.〔【出典】ICHガイドライン 〕

The primary measurements and endpoints used to determine efficacy should be clearly specified.〔【出典】ICHガイドライン 〕

toxicological endpoint

Depending on the situation, the trial could replicate the foreign study or could utilize a standard clinical endpoint in a study of shorter duration than the foreign studies or utilize a validated surrogate endpoint, e.g., blood pressure or cholesterol （longer studies and other endpoints may have been used in the foreign phase III clinical trials）.〔【出典】ICHガイドライン 〕

Such problems or potential problems should be identified and if there were any attempts to assess the magnitude of the problem or manage it （e.g., by having some endpoint measurements carried out by people shielded from information that might reveal treatment assignment）, they should be described.〔【出典】ICHガイドライン 〕