Chapter 13. Clinical Trials

Summary

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.