Data and Safety Monitoring Committees in Clinical Trials- 2nd ed (2016) Pdf Free Download

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When the first edition of this book was published in 2009, a second edition was the furthest thing from my mind. However, in the past 2 years alone, we have seen a huge impetus of regulations and books on safety in drug development. The big push is to guide safety monitoring and analysis toward risk (adverse events) versus benefit (efficacy) and to reduce the paperwork in expedited reporting of adverse events. Terms such as SUSARs, SMQs, PSAP, companion diagnostics, safety assessment committees, and so forth, did not exist, at least in my vocabulary, when I created the first edition in 2008.

The new regulations have been complemented by the development of new statistical methods, which are also described here so that DMC members will have a reference if they should appear at a meeting. Meta-analysis, use of outside data, Bayesian methods, and causal inference are more common today than they were in 2008, so I have given them more ink.

The first edition mentioned the efficacy analysis responsibilities of DMCs but gave no details. This edition provides the statistical elements of planned interim analysis with group sequential methods, conditional power, futility, and so on.

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