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Practical Considerations for Adaptive Trial Design and Implementation / / edited by Weili He, José Pinheiro, Olga M. Kuznetsova
| Practical Considerations for Adaptive Trial Design and Implementation / / edited by Weili He, José Pinheiro, Olga M. Kuznetsova |
| Edizione | [1st ed. 2014.] |
| Pubbl/distr/stampa | New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 |
| Descrizione fisica | 1 online resource (420 p.) |
| Disciplina | 610.724 |
| Collana | Statistics for Biology and Health |
| Soggetto topico |
Statistics
Biostatistics Pharmacy Statistics for Life Sciences, Medicine, Health Sciences Drug Safety and Pharmacovigilance Statistical Theory and Methods |
| ISBN | 1-4939-1100-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- The Need for and the Future of Adaptive Designs in Clinical Development -- Regulatory Guidance Documents on Adaptive Designs: an Industry Perspective -- A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences -- Considerations and optimization of adaptive trial design in clinical development programs -- Optimal Cost-effective Go-No Go Decisions in Clinical Development -- Timing and frequency of interim analyses in confirmatory trials -- Approaches for optimal dose selection for adaptive design trials -- A Review of Available Software and Capabilities for Adaptive Designs -- Randomization Challenges in Adaptive Design Studies -- Response-adaptive randomization for clinical trials -- Implementing Adaptive Designs: Operational Considerations, Putting it all together -- Implementation Issues in Adaptive Design Trials -- Implementing Adaptive Designs; Using Technology to Protect Trial Integrity, Reduce Operational Bias, and Build Regulatory Trust -- Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of DMCs -- Approaches for Clinical Supply Modelling and Simulation -- Approaches for Patient Recruitment Modeling and Simulation -- A case study for adaptive trial design consideration and implementation -- Design Considerations for a Phase Ib Randomized, Placebo-Controlled, 4-Period Cross-over Adaptive Dose-Finding Clinical Trial -- Continual Reassessment Method for a First-In-Human Trial: From Design to Trial Implementation -- Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and its Implementation: ADVENT Trial. |
| Record Nr. | UNINA-9910299977903321 |
| New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Real-World Evidence in Medical Product Development / / edited by Weili He, Yixin Fang, Hongwei Wang
| Real-World Evidence in Medical Product Development / / edited by Weili He, Yixin Fang, Hongwei Wang |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (431 pages) |
| Disciplina | 615.19 |
| Soggetto topico |
Statistics
Artificial intelligence—Data processing Computer science—Mathematics Data Science Mathematics of Computing Desenvolupament de medicaments Assaigs clínics |
| Soggetto genere / forma | Llibres electrònics |
| Soggetto non controllato |
Therapeutics
Medical |
| ISBN | 3-031-26328-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface -- Part I. Real-World Data and Evidence to Accelerate Medical Product Development -- The need for real world data/evidence in clinical development and life cycle management, and future directions -- Overview of current RWE/RWD landscape -- Key considerations in forming research questions -- Part II. Fit-for-use RWD Assessment and Data Standards -- Assessment of fit-for-use real-world data sources and applications -- Key variables ascertainment and validation in real-world setting -- Data standards and platform interoperability -- Privacy-preserving data linkage for real-world datasets -- Part III. Causal Inference Framework and Methodologies in RWE Research -- Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence -- Framework and Examples of Estimands in Real-World Studies -- Clinical Studies Leveraging Real-World Data Using Propensity Score-Based Methods -- Recent statistical development for comparative effectiveness research beyond propensity-score methods -- Innovative Hybrid Designs and Analytical Approaches leveraging Real-Word Data and Clinical Trial data -- Statistical challenges for causal inference using time-to-event real-world data -- Sensitivity Analyses for Unmeasured Confounding: This is the way -- Sensitivity analysis in the analysis of real-world data -- Personalized medicine with advanced analytics -- Use of Real-World Evidence in Health Technology Assessment Submissions -- Part IV. Application and Case studies -- Examples of applying causal-inference roadmap to real-world studies -- Applications using real-world evidence to accelerate medical product development -- The use of real-world data to support the assessment of the benefit and risk of a medicine to treat spinal muscular atrophy -- Index. |
| Record Nr. | UNINA-9910726291303321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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