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Reference:ICH ICH E8 Guideline R1 (2021) 5.: Difference between revisions

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{{#set:
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|tags=TAG-00033-Pro-oto ++ TAG-00302-Ada-die ++ TAG-00055-Stu-ngs ++ TAG-00011-Inv-tud
== Document Information ==
|tags_display=[[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00302-Ada-die|Adaptive design]], [[Glossary:TAG-00055-Stu-ngs|Study design]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]]
{{:Document:ICH ICH E8 Guideline R1 (2021)}}
|comment=Design elements for master protocol and platform trial studies
 
|content=5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES
== Reference Details ==
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! scope="row" style="width:200px;" | Scope
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! scope="row" style="width:200px;" | Document part
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! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
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! scope="row" style="width:200px;" | Contributors
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== Text ==
5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES
[…]
[…]
Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework.  
Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework.  
Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules.
Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules.
}}

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 2 — Unit 2.1.3
Scope HM
Document part 5.
Language EN
Original entry by Florian Adragna
Contributors
Tags Protocol, Adaptive design, Study design, Investigational drug (IMP)

Content

5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES […] Master protocol studies allow for the investigation of multiple drugs or multiple conditions under a shared framework. Platform studies allow for multiple drugs to be investigated in a continuous manner, with different drugs entering the study at different times and leaving the study based on pre-specified decision rules.

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