This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course activities will also be available for the interested participants.
On successful completion of this Module the student should be able to: Describe the various types of clinical studies and the methods used to choose the appropriate design. Describe the main statistical methods used in clinical research. Identify the key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution. Discuss the collection, evaluation and reporting of adverse event data in clinical trials. Outline the various quality management issues in clinical trials. Describe the impact of emerging results on the drug development plan. Outline the key operational and strategic issues in the clinical development plan. Explain the evaluation of the outcome of drug development: final therapeutic profile/usage of a medicine. Describe the role of the Target Product Profile (TPP) and Target Product Claims (TPC). Explain the role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees. Discuss the statistical issues in statistical report writing. Describe the evaluation and interpretation of clinical trial results. Illustrate the principles and practical application of critical appraisal.