Real-world evidence in drug development and evaluation:
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton ; London ; New York
CRC Press
2021
|
| Ausgabe: | First edition |
| Schriftenreihe: | Chapman & Hall/CRC biostatistics series
|
| Schlagworte: | |
| Online-Zugang: | TUM01 |
| Beschreibung: | 1. Using Real-world Evidence to Transform Drug Development: Opportunities and ChallengesHarry YangIntroductionTraditional Drug Development ParadigmDrug Development ProgressLimitations of Traditional Randomized Controlled TrialsReal World Data and Real World EvidenceReal World DataReal World EvidenceDifferences between RWE and Outcomes of RCTRegulatory PerspectiveProductivity ChallengeFDA Critical Path InitiativeRegulatory Perspectives Pertaining to RWEHistorical Approval Based on RWEAccess to RWDOpportunities of RWE in Drug DevelopmentEarly DiscoveryClinical Study Design and FeasibilityStudy ExecutionMarketing ApplicationProduct LaunchProduct Lifecycle ManagementChallenges with RWE Data Access and QualityTechnological BarriersMethodological ChallengesLack of Data TalentsRegulatory RisksConcluding Remarks2. . - Evidence derived from real world data: utility, constraints and cautionsDeepak Khatry What is RWD in the context of drug development and clinical practiceWhy is RWD important? For what purposes can RWD be useful? What study designs and statistical methods will be necessary to ensure high quality RWE? Some application examples 3. Real-world evidence from population-based cancer registry Binbing Yu Introduction Statistical methods for population-based cancer registry Application to small cell lung cancer survivalDiscussions 4. External Control using RWE and Historical Data in Clinical Development Qing Li, Guang Chen, Jianchang Lin, Andy Chi and Simon DaviesIntroduction of using RWE and Historical Data in Clinical Development Single Arm Trial Using External Control for Initial Indication Comparison Across Trials with External Control for Label Expansion Important Considerations When Designing Studies and Analyzing Data UsingExternal Control in Clinical Development 5. . - Bayesian method for assessing drug safety using real-world evidence Binbing Yu IntroductionBayesian sensitivity analysis for unobserved confoundersBayesian evidence synthesis using meta-an Description based on online resource; title from digital title page (viewed on March 19, 2021) |
| Beschreibung: | 1 Online-Ressource (xii, 178 Seiten) Illustrationen, Diagramme |
| ISBN: | 9780429676826 0429676824 9780429398674 0429398670 |
Internformat
MARC
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| 500 | |a 1. Using Real-world Evidence to Transform Drug Development: Opportunities and ChallengesHarry YangIntroductionTraditional Drug Development ParadigmDrug Development ProgressLimitations of Traditional Randomized Controlled TrialsReal World Data and Real World EvidenceReal World DataReal World EvidenceDifferences between RWE and Outcomes of RCTRegulatory PerspectiveProductivity ChallengeFDA Critical Path InitiativeRegulatory Perspectives Pertaining to RWEHistorical Approval Based on RWEAccess to RWDOpportunities of RWE in Drug DevelopmentEarly DiscoveryClinical Study Design and FeasibilityStudy ExecutionMarketing ApplicationProduct LaunchProduct Lifecycle ManagementChallenges with RWE Data Access and QualityTechnological BarriersMethodological ChallengesLack of Data TalentsRegulatory RisksConcluding Remarks2. . - Evidence derived from real world data: utility, constraints and cautionsDeepak Khatry What is RWD in the context of drug development and clinical practiceWhy is RWD important? For what purposes can RWD be useful? What study designs and statistical methods will be necessary to ensure high quality RWE? Some application examples 3. Real-world evidence from population-based cancer registry Binbing Yu Introduction Statistical methods for population-based cancer registry Application to small cell lung cancer survivalDiscussions 4. External Control using RWE and Historical Data in Clinical Development Qing Li, Guang Chen, Jianchang Lin, Andy Chi and Simon DaviesIntroduction of using RWE and Historical Data in Clinical Development Single Arm Trial Using External Control for Initial Indication Comparison Across Trials with External Control for Label Expansion Important Considerations When Designing Studies and Analyzing Data UsingExternal Control in Clinical Development 5. . - Bayesian method for assessing drug safety using real-world evidence Binbing Yu IntroductionBayesian sensitivity analysis for unobserved confoundersBayesian evidence synthesis using meta-an | ||
| 500 | |a Description based on online resource; title from digital title page (viewed on March 19, 2021) | ||
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Datensatz im Suchindex
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| author | Yang, Harry Yu, Binbing |
| author_facet | Yang, Harry Yu, Binbing |
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| author_sort | Yang, Harry |
| author_variant | h y hy b y by |
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| dewey-full | 615.1/9 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1/9 |
| dewey-search | 615.1/9 |
| dewey-sort | 3615.1 19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| discipline_str_mv | Medizin |
| edition | First edition |
| format | Electronic eBook |
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| id | DE-604.BV048231798 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T19:51:23Z |
| indexdate | 2024-07-10T09:32:37Z |
| institution | BVB |
| isbn | 9780429676826 0429676824 9780429398674 0429398670 |
| language | English |
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| physical | 1 Online-Ressource (xii, 178 Seiten) Illustrationen, Diagramme |
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| publishDate | 2021 |
| publishDateSearch | 2021 |
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| publisher | CRC Press |
| record_format | marc |
| series2 | Chapman & Hall/CRC biostatistics series |
| spelling | Yang, Harry Verfasser aut Real-world evidence in drug development and evaluation authored by Harry Yang and Binbing Yu First edition Boca Raton ; London ; New York CRC Press 2021 © 2021 1 Online-Ressource (xii, 178 Seiten) Illustrationen, Diagramme txt rdacontent c rdamedia cr rdacarrier Chapman & Hall/CRC biostatistics series 1. Using Real-world Evidence to Transform Drug Development: Opportunities and ChallengesHarry YangIntroductionTraditional Drug Development ParadigmDrug Development ProgressLimitations of Traditional Randomized Controlled TrialsReal World Data and Real World EvidenceReal World DataReal World EvidenceDifferences between RWE and Outcomes of RCTRegulatory PerspectiveProductivity ChallengeFDA Critical Path InitiativeRegulatory Perspectives Pertaining to RWEHistorical Approval Based on RWEAccess to RWDOpportunities of RWE in Drug DevelopmentEarly DiscoveryClinical Study Design and FeasibilityStudy ExecutionMarketing ApplicationProduct LaunchProduct Lifecycle ManagementChallenges with RWE Data Access and QualityTechnological BarriersMethodological ChallengesLack of Data TalentsRegulatory RisksConcluding Remarks2. . - Evidence derived from real world data: utility, constraints and cautionsDeepak Khatry What is RWD in the context of drug development and clinical practiceWhy is RWD important? For what purposes can RWD be useful? What study designs and statistical methods will be necessary to ensure high quality RWE? Some application examples 3. Real-world evidence from population-based cancer registry Binbing Yu Introduction Statistical methods for population-based cancer registry Application to small cell lung cancer survivalDiscussions 4. External Control using RWE and Historical Data in Clinical Development Qing Li, Guang Chen, Jianchang Lin, Andy Chi and Simon DaviesIntroduction of using RWE and Historical Data in Clinical Development Single Arm Trial Using External Control for Initial Indication Comparison Across Trials with External Control for Label Expansion Important Considerations When Designing Studies and Analyzing Data UsingExternal Control in Clinical Development 5. . - Bayesian method for assessing drug safety using real-world evidence Binbing Yu IntroductionBayesian sensitivity analysis for unobserved confoundersBayesian evidence synthesis using meta-an Description based on online resource; title from digital title page (viewed on March 19, 2021) Drug Development Drug development Drug development Evaluation Medicine Research Methodology Yu, Binbing Verfasser aut Erscheint auch als Druck-Ausgabe 978-0-367-02621-9 |
| spellingShingle | Yang, Harry Yu, Binbing Real-world evidence in drug development and evaluation Drug Development Drug development Drug development Evaluation Medicine Research Methodology |
| title | Real-world evidence in drug development and evaluation |
| title_auth | Real-world evidence in drug development and evaluation |
| title_exact_search | Real-world evidence in drug development and evaluation |
| title_exact_search_txtP | Real-world evidence in drug development and evaluation |
| title_full | Real-world evidence in drug development and evaluation authored by Harry Yang and Binbing Yu |
| title_fullStr | Real-world evidence in drug development and evaluation authored by Harry Yang and Binbing Yu |
| title_full_unstemmed | Real-world evidence in drug development and evaluation authored by Harry Yang and Binbing Yu |
| title_short | Real-world evidence in drug development and evaluation |
| title_sort | real world evidence in drug development and evaluation |
| topic | Drug Development Drug development Drug development Evaluation Medicine Research Methodology |
| topic_facet | Drug Development Drug development Drug development Evaluation Medicine Research Methodology |
| work_keys_str_mv | AT yangharry realworldevidenceindrugdevelopmentandevaluation AT yubinbing realworldevidenceindrugdevelopmentandevaluation |