How Long to Read Data and Safety Monitoring Committees in Clinical Trials

How Long Does it Take to Read Data and Safety Monitoring Committees in Clinical Trials?

It takes the average reader 4 hours and 1 minute to read Data and Safety Monitoring Committees in Clinical Trials by Jay Herson

Assuming a reading speed of 250 words per minute. Learn more

Description

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.

How long is Data and Safety Monitoring Committees in Clinical Trials?

Data and Safety Monitoring Committees in Clinical Trials by Jay Herson is 241 pages long, and a total of 60,491 words.

This makes it 81% the length of the average book. It also has 74% more words than the average book.

How Long Does it Take to Read Data and Safety Monitoring Committees in Clinical Trials Aloud?

The average oral reading speed is 183 words per minute. This means it takes 5 hours and 30 minutes to read Data and Safety Monitoring Committees in Clinical Trials aloud.

What Reading Level is Data and Safety Monitoring Committees in Clinical Trials?

Data and Safety Monitoring Committees in Clinical Trials is suitable for students ages 12 and up.

Note that there may be other factors that effect this rating besides length that are not factored in on this page. This may include things like complex language or sensitive topics not suitable for students of certain ages.

When deciding what to show young students always use your best judgement and consult a professional.

Where Can I Buy Data and Safety Monitoring Committees in Clinical Trials?

Data and Safety Monitoring Committees in Clinical Trials by Jay Herson is sold by several retailers and bookshops. However, Read Time works with Amazon to provide an easier way to purchase books.

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