Noninferiority testing in clinical trials: issues and challenges
Saved in:
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton
CRC Press/Taylor & Francis
[2015]
|
| Series: | Chapman & Hall/CRC biostatistics series
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| Subjects: | |
| Online Access: | TUM01 Volltext |
| Physical Description: | 1 Online-Ressource (xvii, 184 Seiten) |
| ISBN: | 1466561491 1466561505 9781466561496 9781466561502 |
Staff View
MARC
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| 245 | 1 | 0 | |a Noninferiority testing in clinical trials |b issues and challenges |c Tie-Hua Ng |
| 264 | 1 | |a Boca Raton |b CRC Press/Taylor & Francis |c [2015] | |
| 264 | 4 | |c © 2015 | |
| 300 | |a 1 Online-Ressource (xvii, 184 Seiten) | ||
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| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 490 | 0 | |a Chapman & Hall/CRC biostatistics series | |
| 505 | 8 | |a Includes bibliographical references and index | |
| 505 | 8 | |a "This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups"--Provided by publisher | |
| 505 | 8 | |a 1. Introduction -- 2. Choice of noninferiority margin for the mean difference -- 3. Choice of noninferiority margin for the mean ratio and hazard ratio -- 4. Noninferiority Hypotheses with Binary Endpoints -- 5. Two statistical approaches for testing the noninferiority hypothesis -- 6. Switching between superiority and noninferiority -- 7. Multiple historical studies and meta-analysis -- 8. Three treatment groups -- 9. Regulatory guidances -- 10. Intention-to-treat versus per-protocol -- 11. Thrombolytic example -- 12. Issues and challenges | |
| 650 | 4 | |a Therapeutic Equivalency | |
| 650 | 4 | |a Controlled Clinical Trials as Topic / methods | |
| 650 | 4 | |a Data Interpretation, Statistical | |
| 650 | 7 | |a MEDICAL / Pharmacology |2 bisacsh | |
| 650 | 7 | |a Clinical trials |2 fast | |
| 650 | 7 | |a Drugs / Therapeutic equivalency |2 fast | |
| 650 | 7 | |a Statistics |2 fast | |
| 650 | 4 | |a Medizin | |
| 650 | 4 | |a Statistik | |
| 650 | 4 | |a Clinical trials |x Methods | |
| 650 | 4 | |a Statistics | |
| 650 | 4 | |a Drugs |x Therapeutic equivalency | |
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Record in the Search Index
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| author | Ng, Tie-Hua |
| author_facet | Ng, Tie-Hua |
| author_role | aut |
| author_sort | Ng, Tie-Hua |
| author_variant | t h n thn |
| building | Verbundindex |
| bvnumber | BV042796783 |
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| contents | Includes bibliographical references and index "This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups"--Provided by publisher 1. Introduction -- 2. Choice of noninferiority margin for the mean difference -- 3. Choice of noninferiority margin for the mean ratio and hazard ratio -- 4. Noninferiority Hypotheses with Binary Endpoints -- 5. Two statistical approaches for testing the noninferiority hypothesis -- 6. Switching between superiority and noninferiority -- 7. Multiple historical studies and meta-analysis -- 8. Three treatment groups -- 9. Regulatory guidances -- 10. Intention-to-treat versus per-protocol -- 11. Thrombolytic example -- 12. Issues and challenges |
| ctrlnum | (OCoLC)895661613 (DE-599)BVBBV042796783 |
| dewey-full | 615.5072/4 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.5072/4 |
| dewey-search | 615.5072/4 |
| dewey-sort | 3615.5072 14 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Electronic eBook |
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| id | DE-604.BV042796783 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:09:47Z |
| institution | BVB |
| isbn | 1466561491 1466561505 9781466561496 9781466561502 |
| language | English |
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| physical | 1 Online-Ressource (xvii, 184 Seiten) |
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| publishDate | 2015 |
| publishDateSearch | 2015 |
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| publisher | CRC Press/Taylor & Francis |
| record_format | marc |
| series2 | Chapman & Hall/CRC biostatistics series |
| spelling | Ng, Tie-Hua Verfasser aut Noninferiority testing in clinical trials issues and challenges Tie-Hua Ng Boca Raton CRC Press/Taylor & Francis [2015] © 2015 1 Online-Ressource (xvii, 184 Seiten) txt rdacontent c rdamedia cr rdacarrier Chapman & Hall/CRC biostatistics series Includes bibliographical references and index "This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups"--Provided by publisher 1. Introduction -- 2. Choice of noninferiority margin for the mean difference -- 3. Choice of noninferiority margin for the mean ratio and hazard ratio -- 4. Noninferiority Hypotheses with Binary Endpoints -- 5. Two statistical approaches for testing the noninferiority hypothesis -- 6. Switching between superiority and noninferiority -- 7. Multiple historical studies and meta-analysis -- 8. Three treatment groups -- 9. Regulatory guidances -- 10. Intention-to-treat versus per-protocol -- 11. Thrombolytic example -- 12. Issues and challenges Therapeutic Equivalency Controlled Clinical Trials as Topic / methods Data Interpretation, Statistical MEDICAL / Pharmacology bisacsh Clinical trials fast Drugs / Therapeutic equivalency fast Statistics fast Medizin Statistik Clinical trials Methods Statistics Drugs Therapeutic equivalency http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=906014 Aggregator Volltext |
| spellingShingle | Ng, Tie-Hua Noninferiority testing in clinical trials issues and challenges Includes bibliographical references and index "This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups"--Provided by publisher 1. Introduction -- 2. Choice of noninferiority margin for the mean difference -- 3. Choice of noninferiority margin for the mean ratio and hazard ratio -- 4. Noninferiority Hypotheses with Binary Endpoints -- 5. Two statistical approaches for testing the noninferiority hypothesis -- 6. Switching between superiority and noninferiority -- 7. Multiple historical studies and meta-analysis -- 8. Three treatment groups -- 9. Regulatory guidances -- 10. Intention-to-treat versus per-protocol -- 11. Thrombolytic example -- 12. Issues and challenges Therapeutic Equivalency Controlled Clinical Trials as Topic / methods Data Interpretation, Statistical MEDICAL / Pharmacology bisacsh Clinical trials fast Drugs / Therapeutic equivalency fast Statistics fast Medizin Statistik Clinical trials Methods Statistics Drugs Therapeutic equivalency |
| title | Noninferiority testing in clinical trials issues and challenges |
| title_auth | Noninferiority testing in clinical trials issues and challenges |
| title_exact_search | Noninferiority testing in clinical trials issues and challenges |
| title_full | Noninferiority testing in clinical trials issues and challenges Tie-Hua Ng |
| title_fullStr | Noninferiority testing in clinical trials issues and challenges Tie-Hua Ng |
| title_full_unstemmed | Noninferiority testing in clinical trials issues and challenges Tie-Hua Ng |
| title_short | Noninferiority testing in clinical trials |
| title_sort | noninferiority testing in clinical trials issues and challenges |
| title_sub | issues and challenges |
| topic | Therapeutic Equivalency Controlled Clinical Trials as Topic / methods Data Interpretation, Statistical MEDICAL / Pharmacology bisacsh Clinical trials fast Drugs / Therapeutic equivalency fast Statistics fast Medizin Statistik Clinical trials Methods Statistics Drugs Therapeutic equivalency |
| topic_facet | Therapeutic Equivalency Controlled Clinical Trials as Topic / methods Data Interpretation, Statistical MEDICAL / Pharmacology Clinical trials Drugs / Therapeutic equivalency Statistics Medizin Statistik Clinical trials Methods Drugs Therapeutic equivalency |
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