Reference:ICH ICH E21 Concept paper 2023 2.: Difference between revisions
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| | |has_document=Document:ICH ICH E21 Concept paper 2023 | ||
| | |module=3 | ||
| | |unit=3.1.4 | ||
| | |scope=G | ||
| | |doc_part=2. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00071-Pre-nis ++ TAG-00154-Vul-eil ++ TAG-00029-Inf-rte ++ TAG-00001-Med-rzn | |||
|tags_display=[[Glossary:TAG-00071-Pre-nis|Pregnancy]], [[Glossary:TAG-00154-Vul-eil|Vulnerable participants]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00001-Med-rzn|Medicinal product]] | |||
|comment=Inclusion of pregnant and breastfeeding individuals in clinical trials | |||
|content=E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials | |||
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E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials | |||
Dated 26 May 2023 | Dated 26 May 2023 | ||
[...] | [...] | ||
2. Background to the proposal and statement of the problem | 2. Background to the proposal and statement of the problem | ||
There is an increasing acknowledgement of the need to generate data for medicinal products in pregnant and breast-feeding individuals. Whilst it is recognized that CTs will usually not be large enough to detect increased risks of rare adverse pregnancy outcomes, it is also recognized that limited clinical information could burden the Health Care Professionals (HCPs) with the task of evaluating the unknown risk and/or benefit of medicinal product use during pregnancy. Inclusion of pregnant and breast-feeding individuals in CTs with appropriate safeguards and informed consent can help to identify pregnancy related changes in pharmacokinetics and/or efficacy needed to provide an appropriate benefit-risk evaluation. | There is an increasing acknowledgement of the need to generate data for medicinal products in pregnant and breast-feeding individuals. Whilst it is recognized that CTs will usually not be large enough to detect increased risks of rare adverse pregnancy outcomes, it is also recognized that limited clinical information could burden the Health Care Professionals (HCPs) with the task of evaluating the unknown risk and/or benefit of medicinal product use during pregnancy. Inclusion of pregnant and breast-feeding individuals in CTs with appropriate safeguards and informed consent can help to identify pregnancy related changes in pharmacokinetics and/or efficacy needed to provide an appropriate benefit-risk evaluation. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E21 Concept paper 2023 |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E21 Concept paper |
| Version / Revision | 2023 |
| Status | N.A. |
| Document type | International guideline |
| Language(s) | EN |
| Description | E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
Dated 26 May 2023 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | G |
| Document part | 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Pregnancy, Vulnerable participants, Informed consent, Medicinal product |
Content
E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials Dated 26 May 2023 [...] 2. Background to the proposal and statement of the problem There is an increasing acknowledgement of the need to generate data for medicinal products in pregnant and breast-feeding individuals. Whilst it is recognized that CTs will usually not be large enough to detect increased risks of rare adverse pregnancy outcomes, it is also recognized that limited clinical information could burden the Health Care Professionals (HCPs) with the task of evaluating the unknown risk and/or benefit of medicinal product use during pregnancy. Inclusion of pregnant and breast-feeding individuals in CTs with appropriate safeguards and informed consent can help to identify pregnancy related changes in pharmacokinetics and/or efficacy needed to provide an appropriate benefit-risk evaluation.
