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Item Details
| Title:
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DATA AND SAFETY MONITORING COMMITTEES IN CLINICAL TRIALS
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| By: |
Jay Herson, Byron Jones, Karl E. Peace |
| Format: |
Hardback |
| List price:
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£72.99 |
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We believe that this item is permanently unavailable, and so we cannot source
it.
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| ISBN 10: |
1420070371 |
| ISBN 13: |
9781420070378 |
| Publisher: |
TAYLOR & FRANCIS LTD |
| Pub. date: |
13 March, 2009 |
| Series: |
Chapman & Hall/CRC Biostatistics Series 30 |
| Pages: |
191 |
| Description: |
Focuses on the practical clinical and statistical issues that arise in pharmaceutical industry trials. This book explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. It also how physicians think differently about safety data than statisticians. |
| Synopsis: |
Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed. |
| Illustrations: |
7 black & white illustrations, 39 black & white tables |
| Publication: |
US |
| Imprint: |
Chapman & Hall/CRC |
| Returns: |
Returnable |
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