13. Clinical Trials

  1. Peter M. Fayers1,2 and
  2. David Machin3,4

Published Online: 8 MAR 2002

DOI: 10.1002/0470846283.ch13

Quality of Life: Assessment, Analysis and Interpretation

Quality of Life: Assessment, Analysis and Interpretation

How to Cite

Fayers, P. M. and Machin, D. (2000) Clinical Trials, in Quality of Life: Assessment, Analysis and Interpretation, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/0470846283.ch13

Author Information

  1. 1

    Medical Research Council Clinical Trials Unit, London, UK

  2. 2

    Unit of Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway

  3. 3

    NMRC Clinical Trials & Epidemiology Research Unit, Singapore

  4. 4

    School of Health and Related Research, University of Sheffield, UK

Publication History

  1. Published Online: 8 MAR 2002
  2. Published Print: 18 APR 2000

ISBN Information

Print ISBN: 9780471968610

Online ISBN: 9780470846285



  • compliance;
  • QoL assessment;
  • protocol;
  • standard operating procedures


Inclusion of QoL in clinical trials, and especially multi-centre clinical trials, presents a number of difficult organisational issues. These include standardisation of the procedures for assessment and data collection, specification of measurement details to ensure consistent QoL assessment, methods for minimising missing data, and the collection of reasons for any missing responses. In particular, many trials report serious problems in compliance. Hence it is important to seek methods of optimising the level of compliance, both of the participating institution and of the patient. A number of methods for addressing these issues are described, which should be considered when writing clinical trial protocols involving QoL assessment. A checklist is provided for points that should be covered in protocols.