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Platform Trial Designs in Drug Development

Umbrella Trials and Basket Trials

Livre broché | Anglais | Chapman & Hall/CRC Biostatistics
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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.

Spécifications

Parties prenantes

Editeur:

Contenu

Nombre de pages :
322
Langue:
Anglais
Collection :

Caractéristiques

EAN:
9780367732639
Date de parution :
18-12-20
Format:
Livre broché
Format numérique:
Trade paperback (VS)
Dimensions :
155 mm x 231 mm
Poids :
576 g

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