The CLINT project is an European Union funded project, run as a specific support action, under the sixth framework programme. It is a 2 year project aimed at supporting the European Group for Blood and Marrow Transplantation (EBMT) to develop its infrastructure for the conduct of trans-European clinical trials in accordance with the EU Clinical Trials Directive, and to facilitate International prospective clinical trials in stem cell transplantation. The initial task is to create an inventory of the existing biostatistical literature on new approaches to survival analyses that are not currently widely utilised. The estimation of survival endpoints is introduced, with an emphasis on recent developments which complements standard analysis. The issues raised are new regression models that allow the estimation of time dependent effect for cause specific hazard, cumulative incidence and more generally mean response. New development in multi state model, with notably, recent regression models that assess the influence of covariates directly on transition probabilities are detailed. Some recent test for comparing cumulative incidence function across treatment arm are introduced. The estimation of centre effect in multi centric studies is also documented. Sample size calculation in the presence of competing risks are then presented. We close with the inventory of available packages and macro in R that implement the previous survival models.
Clinical Epidemiology | Clinical Trials | Survival Analysis
Latouche, Aurelien, "Improving statistical analysis of prospective clinical trials in stem cell transplantation. An inventory of new approaches in survival analysis" (June 2010). COBRA Preprint Series. Working Paper 70.