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portada Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials
Type
Physical Book
Illustrated by
Publisher
Author
Language
English
Pages
322
Format
Hardcover
Dimensions
23.9x16.3x2.3 cm
Weight
0.61 kg.
ISBN13
9781138052451
Edition No.
1
Categories

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

Zoran Antonijevic (Illustrated by) · Robert A. Beckman (Illustrated by) · CRC Press · Hardcover

Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials - Antonijevic, Zoran ; Beckman, Robert A.

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Synopsis "Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials"

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.

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