Reference:ICH ICH E8 Guideline R1 (2021) 5.1: Difference between revisions
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| | |has_document=Document:ICH ICH E8 Guideline R1 (2021) | ||
| | |module=3 | ||
| | |unit=3.2.2 | ||
| | |scope=G | ||
| | |doc_part=5.1 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00077-Inc-gsk ++ TAG-00078-Exc-ssk ++ TAG-00317-Obj-set ++ TAG-00083-Enr-enr ++ TAG-00244-Def-ini | |||
|tags_display=[[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00078-Exc-ssk|Exclusion criteria]], [[Glossary:TAG-00317-Obj-set|Objective]], [[Glossary:TAG-00083-Enr-enr|Enrolment]], [[Glossary:TAG-00244-Def-ini|Definition]] | |||
|comment=Study population selection criteria and objectives | |||
|content=Study Population | |||
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Study Population | |||
The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion criteria for the study | The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion criteria for the study | ||
The degree to which a study succeeds in enrolling the desired population will impact the ability of the study to meet its objectives. | The degree to which a study succeeds in enrolling the desired population will impact the ability of the study to meet its objectives. | ||
The study population may be narrowly defined to reduce the risk to study participants or to maximise the sensitivity of the study for detecting a certain effect. Conversely, it may be broadly defined to more closely represent the diverse populations for which the drug is intended. In general, studies conducted early in a development programme, when little is known about the safety of the drug, are more homogeneous in study population definitions. Studies conducted in the later phases of drug development or post-approval are often more heterogeneous in study population definitions. Such studies should involve participants who are representative of the diverse populations which will receive the intervention in clinical practice. Available knowledge about participant characteristics that may predict disease outcomes or effects of the intervention can be used to further define the study population. | The study population may be narrowly defined to reduce the risk to study participants or to maximise the sensitivity of the study for detecting a certain effect. Conversely, it may be broadly defined to more closely represent the diverse populations for which the drug is intended. In general, studies conducted early in a development programme, when little is known about the safety of the drug, are more homogeneous in study population definitions. Studies conducted in the later phases of drug development or post-approval are often more heterogeneous in study population definitions. Such studies should involve participants who are representative of the diverse populations which will receive the intervention in clinical practice. Available knowledge about participant characteristics that may predict disease outcomes or effects of the intervention can be used to further define the study population. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.2.2 |
| Scope | G |
| Document part | 5.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Inclusion criteria, Exclusion criteria, Objective, Enrolment, Definition |
Content
Study Population The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion criteria for the study The degree to which a study succeeds in enrolling the desired population will impact the ability of the study to meet its objectives. The study population may be narrowly defined to reduce the risk to study participants or to maximise the sensitivity of the study for detecting a certain effect. Conversely, it may be broadly defined to more closely represent the diverse populations for which the drug is intended. In general, studies conducted early in a development programme, when little is known about the safety of the drug, are more homogeneous in study population definitions. Studies conducted in the later phases of drug development or post-approval are often more heterogeneous in study population definitions. Such studies should involve participants who are representative of the diverse populations which will receive the intervention in clinical practice. Available knowledge about participant characteristics that may predict disease outcomes or effects of the intervention can be used to further define the study population.
