The "Clinical Trials Methodology Conference" was the first of its kind in the UK and it attracted a large audience of 450 delegates. Three plenary sessions and eighteen contributed sessions focussed on a wide variety of methodological issues.
Click on the sessions below to view the slide presentations.
Clinical trials collect data on both efficacy and safety. Whereas efficacy data are collected, verified, analysed and reported to address specific trial hypotheses, the handling of safety data is sometimes not as robust. One particular aspect of current importance relates to meta-analyses of safety data based on published summary data. Unfortunately, meta-analyses of safety data are sometimes published without adequate consideration of the comprehensiveness and validity of the input data which might come from both RCTs and observational data, the use of fixed vs random effects modelling, inability to adjust for potentially important covariates, handling of missing data, use of different comparators, Simpson's paradox and, critically, multiple testing. Meta-analytic techniques have the potential to play an important role in the identification and quantification of important safety signals; however they must be robustly conducted in order to make appropriate conclusions.
Complex interventions are widely used in the health service, in public health practice, and in areas of social policy that have important health consequences, such as education, transport, and housing’. The ‘MRC Framework for the Development and Evaluation of Complex Interventions’, sought to improve the design and feasibility of such trials. Since then, the Framework has been updated, and it has been applied in a wide variety of different trial settings.
In recent years there has been an increase in the regulatory and research governance burden for clinical trials in the UK. This has been driven by the translation of the EU Directive on clinical trials into UK law through the Clinical Trials Regulations which, although only relevant for trials of Investigational Medicinal Products (IMPs), has also had an impact on trials of other interventions. In parallel, the NHS Research Governance Framework which applies to all research within the NHS has increased the requirements for research governance for all types of clinical research. Whilst no one would question the need to ensure that all research is conducted to the highest standard to ensure the safety of participants and the reliability of the results, there are concerns that overly rigorous interpretation of the regulations has led to excessive and often inappropriate demands being made on those undertaking non-commercial trials who do not have a large regulatory affairs department to support them as in the pharmaceutical industry. There are many examples of the delays and increased costs of clinical trials as a result of the regulatory and governance demands.