Data and Safety Monitoring Committees in Clinical Trials

ISBN-13: 9780367261276 / Angielski / Miękka / 2019 / 265 str.

Jay Herson

Opis

This book summarizes the author’s experience in serving on many data monitoring committees 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 -sponsored trials.

Spis treści

Preface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.