Document:ICH ICH E9 Guideline 1998: Difference between revisions
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| 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
| 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. ... |
