Module Leaders: Anthony Fox, UK and Katalin Mazalin, Hungary - under discussion The science. methodology and ethics of large, multicenter clinical trials will be reviewed. Specific attention will be given to clinical trials in specific populations: pediatric, elderly subjects as well as patients suffering from rare diseases. Study types, statistical aspects, side effect reporting, the definition of target product profile will be discussed.
Various types of clinical studies and the methods used to choose the appropriate design Main statistical methods used in clinical research Key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution Collection, evaluation and reporting of adverse event data in clinical trials Various quality management issues in clinical trials Impact of emerging results on the drug development plan Key operational and strategic issues in the clinical development plan Evaluation of the outcome of drug development: final therapeutic profile / usage of a medicine. Evidence Based Medicine Role of the Target Product Profile (TPP) and Target Product Claims (TPC) Role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees Statistical issues in statistical report writing Evaluation and interpretation of clinical trial results Principles and practical application of critical appraisal