The MRC Clinical Trials Unit at UCL has been well represented on day one of the joint 4th International Clinical Trials Methodology Conference – Society for Clinical Trials 38th Annual Meeting in Liverpool. Staff from the Unit have given oral presentations on topics including trial monitoring; missing data; network meta-analysis; abstract views; and communicating results to trial participants.
Among the highlights of the day was the presentation by Will Cragg and Sally Stenning of the results of the TEMPER study. Trial monitoring is an expensive and time-consuming task, but vital to ensure the accuracy of the data. TEMPER compared routine onsite monitoring versus triggered onsite monitoring, to see whether it is possible to identify which sites to prioritise for onsite monitoring based on central data.
TEMPER found that sites that were monitored following triggers being identified were no more likely overall to have major or critical findings than sites that were monitored routinely. However, it did seem that sites that had a slow data query resolution time, or protocol deviation were more likely to have major or critical findings. This may help prioritise which sites to monitor onsite.
Ian White and Suzie Cro gave interesting talks on new approaches to handling missing data when analysing trial results, and Suzanne Freeman presented a framework for identifying treatment-covariate interactions in individual participant data network meta-analysis. Andrew Embleton presented an entertaining talk looking at how many people read online conference abstracts from the previous ICTMC conference, concluding that the abstracts are discoverable and accessed worldwide.
Matt Sydes chaired a fascinating session on how to communicate trial results to participants, with contributions from Barbara Bierer of the MRCT at Harvard, Jim Elliott from the National Cancer Research Institute Consumer Forum and Independent Cancer Patients’ Voice, Amanda Hunn from the UK Health Research Authority and Annabelle South from the MRC CTU at UCL. The session covered the regulations and guidelines on how trialists should communicate their results to participants; participant views, and examples from a number of different trials. The conclusion was that this was an area that was complex, but vital to do well.
The conference continues, with more presentations from MRC CTU at UCL scheduled for Tuesday and Wednesday.