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Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials (Chapman & Hall/CRC Biostatistics Series) - Tapa blanda

Libro 93 de 155: Chapman & Hall/CRC Biostatistics
 
9780367732639: Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials (Chapman & Hall/CRC Biostatistics Series)
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ISBN 10: 0367732637 ISBN 13: 9780367732639
Editorial: Routledge, 2020

Sinopsis

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.

"Sinopsis" puede pertenecer a otra edición de este libro.

Acerca del autor

Zoran Antonijevic is Owner and Consultant of Z-Adaptive Design. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. He has authored numerous papers and scientific presentations and edited Optimization of Pharmaceutical R&D Programs and Portfolios.

Robert Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at the Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. He has played significant leadership roles in developing new oncology clinical research groups at four pharmaceutical companies, while co-inventing several novel clinical and statistical development strategies. His versatile publication record comprises more than 250 contributions ranging from computational chemistry to clinical oncology.

The editors are past and current chairs of the Drug Information Association Adaptive Design Scientific Working Group, an international group of over 200 statisticians focused on novel clinical study designs and their role in bringing new medicines to patients.

De la contraportada

Drug development sponsors cannot run individual trials for all products in all indications. This results in missed opportunities. Clinical trial programs known as "basket" and "umbrella" have demonstrated that multi-product, multi-indication trials can be efficient and feasible.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
Routledge
Año de publicación
2020
Idioma
Inglés
ISBN 10 
0367732637
ISBN 13 
9780367732639
Encuadernación
Tapa blanda
Número de edición
1
Número de páginas
322
Editor
Antonijevic Zoran, Beckman Robert A.
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
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Alemania