We have continued to work on practical and statistical issues in the conduct of meta-analyses of clinical trials, and have been reviewing and developing statistical models for relating the magnitude of treatment benefit to measured trial level covariates, with appropriate allowance for residual heterogeneity. Many trials in chronic disease areas require patients to fill in daily diary cards, and these generate long sequences of correlated outcomes. We have been exploring the most appropriate methods for presenting and analysing such longitudinal data, with examples mainly in asthma trials. A recent innovation has been qualitative research looking at the views of trial participants. Parents of babies who participated in a neonatal trial were confused about the concepts of trials and randomisation, but in general would not have preferred the Zelen approach of only asking for informed consent after randomisation and only to the control group.
Further research is in progress to consider what actually happens when consent is requested.
The views of staff as well as parents will be ascertained. A survey is being organised with the Standing Advisory Group on Consumer Development in the NHS Research and Development Programme to identify recent and current practices for invloving consumers in randomized controlled trials. In addition to specific methodological problems, we provide an overall perspective on statistical methods in the design and reporting of medical research generally. In particular, we continue to be closely involved in the Lancet s statistical refereeing practice and policy.