Platform Trial Designs in Drug Development

Released on by Zoran Antonijevic
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  • Platform Trial Designs in Drug Development Book Detail

  • Author : Zoran Antonijevic
  • Release Date : 2018-12-07
  • Publisher : CRC Press
  • Genre : Mathematics
  • Pages : 286
  • ISBN 13 : 1351683926
  • File Size : 52,52 MB
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Platform Trial Designs in Drug Development by Zoran Antonijevic PDF Summary

Book Description: 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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Platform Trial Designs in Drug Development

Platform Trial Designs in Drug Development

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Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically in

Platform Trial Designs in Drug Development

Platform Trial Designs in Drug Development

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Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically in

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions i

Sharing Clinical Trial Data

Sharing Clinical Trial Data

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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge an