Platform trial designs in drug development : umbrella trials and basket trials
著者
書誌事項
Platform trial designs in drug development : umbrella trials and basket trials
（Chapman & Hall/CRC biostatistics series）（A Chapman & Hall book）
CRC Press, c2019
- : hardback
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible.
The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health.
The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
目次
I. Overview of Platform Clinical Trials
Introduction
Robert A. Beckman and Zoran Antonijevic
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 Haggstroem, and Kristian Thorlund.
II. Stakeholders
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 Haggstroem, and Kristian Thorlund.
Decision Analysis from the Perspectives of Single and Multiple Stakeholders
Robert A. Beckman, Carl-Fredrik Burman, Cong Chen, Sebastian Jobjoernsson, Franz Koenig, Nigel Stallard, and Martin Posch.
Optimal Approach for Addressing Multiple Stakeholders' Requirements in Drug Development
Zoran Antonijevic and Zhongshen Wang
III. Statistical Methodology
Primary Site Independent Clinical Trials in Oncology
Richard M. Simon
Platform Trials
Ben Saville and Scott Berry
Efficiencies of Platform TrialsSatrajit 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
IV. Conclusions
An executive's view of value of platform trials
David Reese and Phuong K Morrow
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