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Data and Safety Monitoring Committees in Clinical Trials
Af: Jay Herson
Engelsk
Bogcover for Data and Safety Monitoring Committees in Clinical Trials af Jay Herson, 9780367261276
Specifikationer
Sprog:
Engelsk
Sider:
241
ISBN-13:
9780367261276
Indbinding:
Paperback
Udgave:
2
ISBN-10:
0367261278
Kategori:
Udg. Dato:
22 mar 2019
Størrelse i cm:
23,4 x 15,6
Forlag:
Serie:
Oplagsdato:
22 mar 2019
Forfatter(e):
Genre:

Data and Safety Monitoring Committees in Clinical Trials

Af: Jay Herson
Engelsk
Paperback 2019
Format:
Paperback
Bog beskrivelse

Praise for the first edition:

"Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC."

-S. T. Ounpraseuth, The American Statistician

　

In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff.

The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition.

　

New to the Second Edition:

  • Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives.

  • Newly added interim analysis for efficacy and futility section.

  • DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc.

  • DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan)

  • Use of patient reported outcomes of safety

  • Use of meta analysis and data outside the trial

  • New ideas for training and compensation of DMC members

    • 　

    Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

    　

    　

    　

    　

    　

    　

    　

    　

    　

    　

    　

    　

    　
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Forlags Vejl. pris
570,84 kr
Hos Booktok
499 kr
spar 13%
Læg i kurv nu
Sikker betaling
90 dages retur
23 - 25 hverdage
Specifikationer
Sprog:
Engelsk
Sider:
241
ISBN-13:
9780367261276
Indbinding:
Paperback
Udgave:
2
ISBN-10:
0367261278
Kategori:
Udg. Dato:
22 mar 2019
Størrelse i cm:
23,4 x 15,6
Forlag:
Serie:
Oplagsdato:
22 mar 2019
Forfatter(e):
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