Masterclass on Clinical Research: How to design a clinical trial DAY 1 (Tuesday, 5 March 2013) - Core skills for clinical research 09:30-10:30 Registration and Coffee 10:30 10:35 Welcome Rupert Pearse & Andreas Hoeft 10:35 11:10 Legislation governing research Markus Ambrosius 11:00-11:30 Coffee break 11:10 11:45 Good Clinical Practice in research Maria Wittmann 11:45 12:30 Applying for regulatory approval Karoline Buhre 12:30 13:30 Lunch 13:30 14:15 Presenting your data Martin Tramèr 14:15 15:00 Getting Published Martin Tramèr 15:00 15:30 Coffee break 15:30 16:15 Finding funding Rupert Pearse 16:15 16:45 Questions and Answers Rupert Pearse 16:45 17:00 Planning for day two Rupert Pearse - 1-
DAY 2 (Wednesday, 6 March 2013) Planning your clinical research 9:00 10:00 10:00 10:30 Study design: overview Planning an observational study Rupert Pearse Rupert Pearse 10:30:11:00 Planning a Clinical trial Rupert Pearse 11:00 11:30 Coffee break 11:30 13:00 Surviving statistics Shaman Jhanji 13:00 13:40 Lunch 13:40 14:00 14:00 15:00 15:30 16:45 16:45 17:00 15:00 15:30 Coffee break Measurements and data collection Workshop I: Design your own study * Workshop I: Design your own study* Questions and Answers Shaman Jhanji * Please see page 4 - - 2 -
DAY 3 (Thursday, 7 March 2013) 9:00 10:30 Workshop II: Planning a study as a team* 10:30 11:00 Coffee break 11:00 12:00 Workshop II: Planning a study as a team * 12:00 13:00 Presentation of trial proposal 13:00 14:00 Lunch 14:00 14:45 How to read a paper Andreas Hoeft & Rupert Pearse 14:45 15:00 Summary Rupert Pearse 15:00 End of course * Please see page 4-3 -
WORKSHOPS There will be two workshops during the course. The first will be Design your own study during which the faculty will support and advise delegates as they develop and improve the protocol for a study which is of particular interest to them. Some delegates may have research idea which is already well developed whilst others may have a proposal in the very early stages. Either will allow us the opportunity to give practical training. It would be very helpful if each delegate could arrive at the course with a research idea which we can use as the basis for their teaching during this workshop. The second workshop Planning a study as a team will involve group working to solve problems in study design and planning. Groups will work together much like a trial steering committee to negotiate a resolve problems before presenting their final trial proposal to the group. No preparation is required for this workshop. FACULTY Speaker Markus Ambrosius Markus Ambrosius is a partner of Sträter Lawyers, Germany. He advises pharmaceutical companies on aspects of European and German pharmaceutical law. His main areas of expertise are: - European marketing authorisation procedures, referral and pharmacovigilance procedures, - Clinical trials, - Regulatory data protection, - Court cases, - Contractual arrangements for the performance of clinical trials and drug monitoring (e.g. with CRO and investigators.) Markus has studied law at the Ruhr-Universität Bochum. He has given lectures at the University of Marburg. He is a lecturer at the University of Bonn for pharmaceutical law. Markus has handled - 4 - several landmark cases at national courts in Germany and at the ECJ. Speaker: Dr. Karoline Buhre, Karoline Buhre graduated from Medical School of the University of Göttingen in 1994. Following a residency in Anaesthesiology in Göttingen she was granted the European Diploma in Anaesthesiology and Intensive Care. She is also qualified in special Pain Therapy. Since 2002 she works as clinical assessor in the field of anaesthesiology and pain therapy at the Federal Institute for Drugs and Medical Devices (BfArM) Bonn and is nominated as a European expert providing scientific expertise to the European Medicines Agency (EMA). Speaker: Professor Andreas Hoeft, Secretary of ESA, Chair of ESA Research Committee.
Andreas Hoeft graduated from Medical School of the University of Münster in 1981. After six years of basic research in cardiovascular physiology he earned a PhD degree (Habilitation) in Physiology. Following a residency in Anaesthesiology in Göttingen he worked for two years (1991-1992) as visiting professor in Houston, Texas. In 1992 he completed a second habilitation in Anaesthesiology and Intensive Care Medicine. His major research interest is cardiovascular physiology, pharmacokinetics and dynamics, genetics in anesthesia and intensive care, clinical research and epidemiology. Since 1995 chairman of the department of Anaesthesiology and Intensive Care Medicine in Bonn, Germany Speaker: Shaman Jhanji, Royal Marsden NHS trust, London, UK. Shaman Jhanji graduated from medical school in Birmingham, UK. He subsequently trained in internal medicine and then anaesthesia in London. He went on to gain sub-specialty training in Intensive Care Medicine in London and is currently working as a Consultant in Intensive Care Medicine and Anaesthesia at the Royal Marsden Hospital, London. He holds a PhD from the University of London after completing a series of studies investigating the microcirculation in critical illness. His research interests include perioperative risk prediction, outcomes following major surgery and microvascular flow. Speaker: Rupert Pearse, London, United Kingdom Rupert Pearse graduated in 1996 from St George's Hospital Medical School, London, UK. After time working in general medicine and anaesthesia, he returned to St George's Hospital where he developed many of his current research interests and completed his training in Intensive Care Medicine. In 2006, he was appointed Senior Lecturer in Intensive Care Medicine at Barts and The London School of Medicine and Dentistry and was promoted to Reader in 2011. He has now given up anaesthesia to concentrate on his clinical duties on the intensive care unit at The Royal London Hospital and his research interests in improving outcomes following major surgery and the cardiovascular pathophysiology of critical illness. Rupert plays a leading role in a number of large multi-centre studies including OPTIMISE, EuSOS and VISION. Speaker: Professor Martin Tramèr, Editor, European Journal of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland Martin Tramèr graduated from Medical School in Basel, Switzerland. He trained as an anaesthetist in various hospitals in Switzerland. He holds a DPhil from Oxford University, Oxford, UK, with a thesis about meta-analyses. He is currently Head of Unit, Division of Anaesthesiology, Geneva University Hospitals and Adjunct Professor, Medical Faculty, Geneva University, Switzerland. In 2010 he became the Editor-in-Chief of the European Journal of Anaesthesiology. Speaker: Maria Wittmann, MD, consultant for Anaesthesiology, Department of Anaesthesiology and Intensive Care Medicine, University Hospital, Bonn, Germany. Maria Wittmann graduated from the University of Bonn, Germany in 2001. From 2001 to 2006, she was trained as an anaesthesiologist. She completed a fellowship in pain medicine in 2011. Her responsibilities include student education and clinical research. She is currently the head of the clinical trial group of her department. Her experimental and clinical research focuses on pain medicine, electrophysiology and perioperative care. - 5 -