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hi all, YSS and the East Cumbria local group have teamed up to organize the following seminar on medical statistics: A joint event between the YSS (young statisticians section) and the Lancashire and East Cumbria local group will take place 3-5.30pm on Thu 14 June at Lancaster University (Fylde LT1) LA1 4YF. It will be followed by a wine reception in the Postgraduate Statistics Centre. We welcome three career young statisticians, working in the area of medical statistics: Patrick Phillips (MRC clinical trials unit), Tom Fanshawe (CHICAS, Lancaster Medical School) and Peter Kimani (Health Sciences, University of Warwick). Titles of talks and abstracts follow at the end of this email. We look forward to seeing you here in Lancaster. There is no need to register, but if you have any queries please contact Matt Sperrin ([log in to unmask]) or Lisa Hampson ([log in to unmask]). *** 3pm: Patrick Phillips: Eradicating the world's oldest infectious disease: challenges in designing clinical trials of new treatments for tuberculosis Tuberculosis (TB) is considered the oldest infectious disease known to man, but continues to be major global health problem in the 21st Century. The World Health Organisation declared TB a global emergency in 1993, and in 2010 there were 8.8 million new cases and over 1 million deaths from TB. The current standard of care is a 4-drug 6-month regimen that has been consistently shown to have efficacy of 90-95% in randomised controlled trials in a variety of settings. These numbers are not reflected in clinical practice with cure rates unfortunately much lower that those seen in clinical trials. The rising levels of drug resistance and co-infection with HIV also contribute to global morbidity and mortality. New combination regimens for TB that are shorter, safer and easier to adhere to are urgently needed. There are a number of new drugs in the pipeline with two or three now reaching phase III trials. Licensed drugs are also being repurposed at different doses or for new indications In this talk I will discuss some of the challenges in designing and conducting late phase clinical trials to evaluate new regimens for the treatment of TB. These include: designing trials of combinations rather than compounds; the need for non-inferiority trials and the complexities in defining the margin of non-inferiority; distinguishing between relapse and new re-infection and the role of adaptive designs. None of these challenges are unique to the disease area of TB, but I will show what work has been done to address them in this context and also what questions are outstanding and where there is work to do! *** 3.45pm: Tom Fanshawe: Multilevel models for cancer progression Biological studies of cancer progression typically generate multilevel data: numerical summaries of properties of cells nested within tumour sites within individuals. This talk gives an overview of statistical methods used to analyse data of this type. Two applications illustrate the overall theme. The first looks at identification of biological markers to detect departure from the cell cycle that governs the renewal of healthy cells, with a view to improving early-stage cancer diagnosis. The second investigates the variation in properties of lymph cells in response to the presence of uterine cancer, which provides insights into the sequelae and metastasis of this cancer type. Joint models for analysing a continuous outcome (cell size) and a cluster size variable (number of cells), when these variables are highly correlated, are also discussed in relation to this second application. *** 4.30pm: Tea *** 4.45pm: Peter Kimani: Conditionally unbiased estimation in adaptive seamless designs. In order to accelerate development of new drugs, adaptive seamless designs have been proposed in clinical trials. Examples of trials that use ASDs are the seamless phase II/III clinical trials. Unlike traditional testing strategy that involve a separate phase II trial and a separate phase III trial, seamless phase II/III clinical trials combine phases II and III into a single trial with two stages. Stage 1 is used to answer phase II objectives such as treatment selection and stage 2 is used for the confirmatory analysis which is a phase III objective. Although these trials are attractive because the confirmatory analysis includes phase II data from stage 1 and hence possible saving on the number of patients required, they can pose statistical challenges. The inference methods used for trials that do not have an interim analysis and compare a single experimental treatment to a control are no longer appropriate. In this talk, I will consider estimating treatment difference after a seamless phase II/III clinical trial. I will describe some methods that account for the adaptive nature of seamless phase II/III clinical trials. *** 5.30pm: Wine reception As always with the best wishes, Oliver Ratmann on behalf of the Young Statisticians of the Royal Statistical Society