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Platform Trial Designs in Drug Development Umbrella Trials and Basket Trials
Platform Trial Designs in Drug Development Umbrella Trials and Basket Trials

Detalls del llibre

I-SPY2 : unlocking the potential of the platform trial / Laura Esserman, Nola Hylton, Smita Asare, Christina Yau, Doug Yee, Angie Demichele, Jane Perlmutter, Fraser Symmans, Laura van't Veer, Jeff Matthews, Don Berry, and Anna Barker -- The challenges with multi-arm targeted therapy trials / Ryan J. Sullivan and Keith Flaherty -- Basket trials at the confirmatory stage / Robert A. Beckman and Cong Chen -- Harnessing real world data to inform platform trial design / Daphne A. Guinn, Subha Madhavan, and Robert A. Beckman -- Impact of platform trials on pharmaceutical frameworks / Zoran Antonijevic, Edward Mills, Jonas Häggström, and Kristian Thorlund -- Friends of cancer research perspective on platform trials / Jeff D. Allen, Madison Wempe, Ryan Hohman, and Ellen Sigal -- Regulatory and policy aspects of platform trials / Rasika Kalamegham, Ramzi Dagher, and Peter Honig -- Multi-arm, multi-drug trials from a reimbursement perspective / Anja Schiel, and Olivier Collignon -- Highly efficient clinical trials : a resource-saving solution for global health / Edward Mills, Jonas Häggström, and Kristian Thorlund -- Decision analysis from the perspectives of single and multiple stakeholders / Robert A. Beckman, Carl-Fredrik Burman, Cong Chen, Sebastian Jobjörnsson, Franz König, Nigel Stallard, and Martin Posch -- Optimal approach for addressing multiple stakeholders' requirements in drug development / Zoran Antonijevic and Zhongshen Wang -- Primary site independent clinical trials in oncology / Richard M. Simon -- Platform trials / Ben Saville and Scott Berry -- Efficiencies of platform trials / Satrajit Roychoudhury and Ohad Amit -- Control of type I error for confirmatory basket trials / Cong Chen and Robert A. Beckman -- Benefit-risk assessment for platform trials / Chunlei Ke and Qi Jiang -- Effect of randomization schemes in umbrella trials when there are unknown interactions between biomarkers / Janet LI, Shuai Yuan, and Robert A. Beckman -- Combinatorial and model-based methods in structuring and optimizing cluster trials / Valerii Fedorov and Sergei Leonov -- An executive's view of value of platform trials / David Reese and Phuong K Morr.
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  • Autors Zoran Antonijevic, Bastiaan Robert Von Benda-Beckmann
  • ISBN13 9781138052451
  • ISBN10 1138052450
  • Pàgines 303
  • Any Edició 2018
  • Fecha de publicación 13/11/2018
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Platform Trial Designs in Drug Development Umbrella Trials and Basket Trials

Platform Trial Designs in Drug Development Umbrella Trials and Basket Trials

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