Clinical drug research

Academic year: 2009-2010 Course code module 1MBMW-K-028 Semester: 2nd semester Credits: 6 Study load (hours) 168 Theory (hours): 30,00 Practice/Exercises(hours): Other (hours): 15,00 Part-time program: 1 Instructor(s) Pierre Van Damme Language of instruction: Dutch Semester exam information: exam in the 2nd semester Contract restriction information: 1. Prerequisites *Algemene competenties Basic knowledge on Biostatistics and Epidemiology Being capable of gathering and assimilating information, in Dutch and in English. Being fluent in English, both orally and in written. Foreknowledge of the course on Preclinical Drug Research (1Ma BMW) is an absolute requirement. *Sequentiality None For the programme 'Biomedical Sciences' also compulsory enrolment in '1MBMW-K-0271 Preclinical drug research'. 2. Objectives (expected learning outcomes) At the end of the course: you will have gathered insight in the complex process of the clinical phase of drug development, vaccine development and medical devices development by pharmaceutical and biotechnological companies you have knowledge on the different actors involved in this process, and you are capable of describing their specific roles you can express their specific perceptions and expectations you understand the need for strict regulations in clinical research you know the existing rules and regulations, and are able to correctly describe them (in your own words) you know the historical background of the current rules and regulations you are capable of writing Standard Operating Procedures you have thorough knowledge of the structure and the content of a clinical trial protocol and of the other documents involved in performing clinical trials you can discuss the possible options regarding study design and their consequences you are capable of reading, mastering, summarizing and presenting (for different target audiences) a study protocol orally and in writing, with or without using visual aids taking into account the level of foreknowledge in the target audience you have gained insight in the registration of (new) drugs, vaccines and medical devices you can discuss the differences between these categories you are able to correctly situate the clinical data in a registration file you are aware how clinical research relates to, and builds upon the results of preclinical research you are capable of applying the current rules and regulations you are capable of - with minimal coaching - using your knowledge in practice, during an internship in a clinical research environment gathering information writing documents communicating with all (types of) persons involved you will have gained the necessary knowledge and skills, when complemented by the practical experience of your internship and your Master's thesis, to swiftly move on to an executive or a coordinating position within clinical research. 3. Course content Building upon the foreknowledge of the course on Preclinical (Non-clinical) Drug Research, you get an overview of the whole process of Clinical Drug Research. Using the "standard" drug development as an example, some particular other settings (paediatric clinical trials, medical device studies, vaccine trials) are also discussed. The current rules and regulations are explained and put into a historical perspective. You get to know the different actors involved in clinical drug research, their respective roles and the way they interact between one another. Some standard documents and procedures are explained. Near the end of the course we look into the role of the regulating bodies, the registration of new drugs, and into some future trends in clinical research. The course takes a Belgian perspective, while respecting the Europian and the international context of clinical research. A group assignment allows you to get acquainted with a number of standard documents, to master clinical trial-related information and to report orally and in writing to different target audiences. 4. Teaching method Direct contact: Lectures Tutorials Personal work: Assignments - individual Assignments - in group Excursion(s) 5. Assessment method Exam: Written, without oral presentation Closed book Open questions Written assignment: Without oral presentation Presentation 6. Compulsory reading – study material Course materials: PowerPoints used during classes Some background documents (in English) Supporting materials: some useful Internet links review papers All materials will be made available on BlackBoard 7. Recommended reading - study material Further reading: Trouet C, Gobert M, Podoor M. Clinical Trials in Belgium. (The Belgian implementation of the European Clinical Trials Directives. An operational guidance). 2de Ed. (2007), incl. CD-ROM. Intersentia ISBN: 9789050956871 A standard for those performing clinical research in Belgium. Rang H.P. Drug Discovery and Development: Technology in Transition. 1st Ed. (2005). Elsevier Health Sciences. ISBN: 9780443064203 Course materials for Preclinical Drug Research; also includes some chapters on the clinical development. 8. Tutoring There is room for questions before and after classes. Lecturers can be consulted by appointment (made by phone or by e-mail): dr. Koen Van Herck prof. dr. Pierre Van Damme laatste aanpassing: last update: 06/07/2009 15:08 dorien.ivens