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The Centre for Biostatistics at The University of Manchester holds half-day seminars each March and October focussed around a designated theme. Our next seminar takes place on October 15th on 'aspects of design in randomised trials', and features three excellent speakers. The seminar will also be a joint meeting with the Royal Statistical Society Manchester Local Group. All are welcome to attend. The seminar is free, but registration is required for catering purposes. Please register in advance at: https://www.eventbrite.co.uk/e/aspects-of-design-in-clinical-trials-registration-12617492259 ----------------------------------------------------------------- Date: Wednesday 15th October 2014 Time: 14.00-17.00 Venue: Manchester Dental Education Centre (MANDEC), Higher Cambridge Street, Manchester, M15 6FH Theme: Aspects of design in clinical trials Programme: 14:00 - 14:50 "Randomisation as a matter of routine in daily clinical practice" Professor Tjeerd Van Staa (Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester) Randomised trials are considered the 'gold-standard' for assessing the effects of healthcare interventions. Trials are now often conducted in specialist centres with careful selection and monitoring of clinicians and participants. But trial evidence is lacking for many clinical decisions that clinicians face in day-to-day practice. The presentation will discuss how routinely collected data (such as electronic health records) could help in conducting pragmatic trials at the point of care and minimise the uncertainty around routinely used interventions. The opportunities and challenges of two exemplar trials that used electronic health records will be presented and it will be explored how and whether trials can be better integrated into routine clinical care. 14:50 - 15:40 "A review of methods for specifying the target difference in randomised controlled trials" Dr Jonathan Cook (University of Oxford) Randomised controlled trials (RCTs) are widely considered the preferred way to compare health interventions. Central to the design of a RCT is a calculation of the number of participants needed. This provides reassurance that the trial will identify a difference of a particular magnitude (the target difference) if such a difference exists. From both a scientific and ethical standpoint, selecting an appropriate target difference is crucial. The size also has clear implications for trial conduct and management, and the overall cost. Surprisingly, given its importance, determination of the target difference for a RCT has been greatly neglected. In this talk, the findings from DELTA, a project which looked at methods for specifying the target difference in a RCT sample size calculation, will be presented and discussed. 15:40 - 16:00 Refreshments 16:00 - 16:50 "We need more multi-arm randomised clinical trials" Professor Mahesh Parmar (MRC Clinical Trials Unit at UCL) Well-designed and well-conducted randomised controlled trials (RCTs) are the most reliable way to identify safe, superior treatments. A key problem is the relatively small number of superiority trials (25-50%) that report success-i.e., that the new treatment is better than the control. However, the research community persists with the traditional two-arm design as the key way in which to measure superiority; of superiority RCTs registered between January, 2010 and July, 2012, around 80% had only two arms. We argue for a cultural shift to multi-arm, phase 3 superiority RCTs. Developing this idea further we introduce the idea of the multi-arm, multi-stage (MAMS) designs. This allows several new treatments to be compared against a single control arm, and seamless progression from Phase II to Phase III trials. Arms can be dropped early, due to insufficient activity, or added as new treatments become available for testing. The STAMPEDE prostate cancer trial uses the MAMS design. It started with six arms, but has since dropped two, and added a further three. STAMPEDE will assess 8 questions in 15 years, which would have taken more than 40 years in separate 2 arm trials. In this presentation we discuss the motivation and some of the statistical and practical issues in the design and conduct of such trials. Registration: The seminar is free to attend, but registration is required for catering purposes. Please register in advance at: https://www.eventbrite.co.uk/e/aspects-of-design-in-clinical-trials-registration-12617492259 For any other queries, please contact Wendy Lamb on 0161 275 7564 or [log in to unmask] You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.