There is an urgent need for new methods for many clinical studies. For example, challenges include speeding up the evaluation of new therapies, finding cost-effective evidence-based methods for running trials, and developing more robust approaches to analysing time-to-event data. Our methodology programme directly relates to the real challenges of clinical research, often those faced directly in our studies. We aim to identify methodologically innovative solutions to these problems, and to provide complementary practical guidance, software and training to enable wider use of new methodology.
Our priorities are methods which have a direct impact on the design, conduct or primary analysis of our or other people's studies.
Our work falls into three categories:
Since April 2008 we have hosted the London Hub for Trials Methodology Research, part of a network of regional Hubs. This has helped to allow us to increase the amount of time we devote to methodological research, alongside developing and running clinical studies.
As the pace of therapeutic development is throwing up ever more urgent methodological issues in our priority areas, we aim to expand our established methodological programme to meet these challenges. Key to this will be our collaborations with many external organisations and individual researchers, including the London School of Hygiene and Tropical Medicine, MRC Biostatistics Unit, MRC Network of Hubs for Trials Methodology Research, UCL Institute of Clinical Trials and Methodology, the Cochrane Collaboration and Amgen; we have initiated collaborations with GSK and Roche.