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Document:ICH ICH E9 Guideline 1998: Difference between revisions

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== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:ICH ICH E9 Guideline 1998 III]] || HM || III || EN || III. TRIAL DESIGN CONSIDERATIONS 3.1 Design Configuration 3.1.1 Parallel Group Design […] 3.1.2 Crossover Design […] 3.1.3 Factorial Designs […] 3.2 Multicentre Trials […] 3.3 Type of Comparison ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 2.3]] || HM || 2.3 || EN || 2.3 Design Techniques to Avoid Bias The most important design techniques for avoiding bias in clinical trials are blinding and randomisation, and these should be normal features of most controlled ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 2.3.1]] || HM || 2.3.1 || EN || [...] Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subject’s physician for the subject’s care. Any ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy]] || HM || Glossary - Double-Dummy || EN || Double-Dummy A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC]] || HM || Glossary - IDMC || EN || Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by ...
|-
| [[Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout]] || HM || Glossary - Dropout || EN || Dropout A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol.
|-
| [[Reference:ICH ICH E9 Guideline 1998 4.5]] || HM || 4.5 || EN || 4.5 Interim Analysis and Early Stopping An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial. ...
|}
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Latest revision as of 14:15, 16 July 2026


Document information
Reference ICH ICH E9 Guideline 1998
Validity area ICH
Scope(s) HM
Document name ICH E9 Guideline
Version / Revision 1998
Status Current
Document type International guideline
Language(s) EN
Description STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
ICH ICH E9 Guideline 1998 2.3HM2.3EN2.3 Design Techniques to Avoid Bias The most important design techniques for avoiding bias in clinical trials are blinding and randomisation, and thes…
ICH ICH E9 Guideline 1998 2.3.1HM2.3.1EN[...] Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subjec…
ICH ICH E9 Guideline 1998 4.5HM4.5EN4.5 Interim Analysis and Early Stopping An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at a…
ICH ICH E9 Guideline 1998 Glossary - Double-DummyHMGlossary - Double-DummyENDouble-Dummy A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Su…
ICH ICH E9 Guideline 1998 Glossary - DropoutHMGlossary - DropoutENDropout A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol…
ICH ICH E9 Guideline 1998 Glossary - IDMCHMGlossary - IDMCENIndependent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-m…
ICH ICH E9 Guideline 1998 IIIHMIIIENIII. TRIAL DESIGN CONSIDERATIONS

3.1 Design Configuration 3.1.1 Parallel Group Design […] 3.1.2 Crossover Design […] 3.1.3 Factorial Designs […]

3.2 M…
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