Reference:ICH ICH E8 Guideline R1 (2021) 5.1

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
Comment	Study population selection criteria and objectives

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.