4. Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile

  1. John Talbot3,4 and
  2. Jeffrey K. Aronson5
  1. John Talbot3,4,
  2. Marianne Keisu1 and
  3. Lars Ståhle2

Published Online: 30 JAN 2012

DOI: 10.1002/9780470975053.ch4

Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition

How to Cite

Talbot, J., Keisu, M. and Ståhle, L. (2011) Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile, in Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice, Sixth Edition (eds J. Talbot and J. K. Aronson), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470975053.ch4

Editor Information

  1. 3

    University of Hertfordshire, College Lane, Hatfield AL10 9AB, UK

  2. 4

    Patient Safety, AstraZeneca R&D, Loughborough, LE11 5RH, UK

  3. 5

    University of Oxford Department of Primary Health Care, Oxford, UK

Author Information

  1. 1

    Swedish Orphan Biovitrum AB, SE - 112 76 Stockholm, Sweden

  2. 2

    AstraZeneca R&D, SE-15185 Södertälje, Sweden

  3. 3

    University of Hertfordshire, College Lane, Hatfield AL10 9AB, UK

  4. 4

    Patient Safety, AstraZeneca R&D, Loughborough, LE11 5RH, UK

Publication History

  1. Published Online: 30 JAN 2012
  2. Published Print: 2 DEC 2011

ISBN Information

Print ISBN: 9780470986349

Online ISBN: 9780470975053

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Keywords:

  • adverse events;
  • adverse drug reactions;
  • clinical trials;
  • safety monitoring;
  • checklists;
  • questionnaires;
  • safety biomarkers;
  • phase I studies;
  • QT studies;
  • Data Monitoring Committees;
  • Investigator's Brochure;
  • Common Technical Document;
  • ICH Guidelines

Summary

Here we describe the collection of adverse events and other data, such as safety biomarkers in clinical trials, in order to determine the adverse drug reactions profile of an investigational drug. We consider the safety aspects of phase I studies in detail from a practical perspective. We also discuss the safety of special subgroups, such as children, in clinical trials and cover the presentation and interpretation of safety data in the clinical study report, Common Technical Document, and literature publications.