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Innovative Designs and Analyses for Small Population Clinical Trials

By Jingjing Ye

Innovative Designs and Analyses for Small Population Clinical Trials Medicine

Innovative Designs and Analyses for Small Population Clinical Trials

0 - Default Title
Description
This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples.
Product details
Binding:
Paperback
Number of Pages:
496
Release Date:
2025-11-20
Publication Date:
2025-11-20
Publisher:
Springer
Languages:
Original: English
ISBN10:
3031608453
ISBN13:
9783031608452
GPSR Manufacturer Reference:
[email protected]
Weight:
744 g
Height:
155 cm
Width:
235 cm
Thickness:
27 cm
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