Standards are needed for quality of life clinical trialsBMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7346.1156 (Published 11 May 2002) Cite this as: BMJ 2002;324:1156
- Andrew Bottomley (), coordinator,
- Fabio Efficace, Lady Grierson research fellow,
- Peter M Fayers, professor
- EORTC Quality of Life Unit, European Organisation for Research and Treatment of Cancer, EORTC Data Centre, 1200 Brussels, Belgium
- Department of Public Health, Aberdeen University Medical School, Aberdeen AB25 2ZD
EDITOR—Jefferson and Demicheli say that health economics studies must come under a high level of scrutiny.1 There are parallels with the field of quality of life in clinical trials, and it is equally important that the BMJ considers developing guidelines concerning this for authors and peer reviewers.
An increasing number of clinical trials assessing quality of life are being published,2 and national bodies such as the National Institute for Clinical Excellence in the United Kingdom and the Food and Drug Administration in the United States increasingly value quality of life in the drug approval process. Yet evidence is growing that published clinical trials assessing quality of life have failed to meet good scientific standards of reporting.3
Recently revised CONSORT guidelines help with designing and reporting good clinical trials, but they fail to address the key issues of clinical trials assessing quality of life. Critical issues such as the selection of quality of life measures, minimal standards of psychometric validity, agreed standards of cultural validity, agreement of acceptable levels of missing data, and standardised methods of analysis and reporting are lacking.
Attempts have been made by some authors, 4 5 but we are still some way from having internationally agreed standards. Several international groups, including the International Society of Pharmocecomics, the European Regulatory Issues on QoL Assessment (ERIQA) Group, the International Society for Quality of Life Research, and the Quality of Life Methods Group of the Cochrane Collaboration, are progressing towards guidelines. Until researchers and peer reviewers are working with the same scientific standards, however, some aspects of the criticism proposed by Jefferson and Demicheli could be equally pertinent for clinical trials assessing quality of life.
Pending the availability of other international standards, we would encourage the BMJ to produce minimal standards for quality of life in clinical trials.