Course catalogue doctoral education - VT24

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Title Basic Principles in Clinical and Translational Research
Course number 3194
Programme 0-Inte del av forskarutbildningsprogram
Language English
Credits 1.5
Date 2019-10-14 -- 2019-10-18
Responsible KI department Institutionen för onkologi-patologi
Specific entry requirements
Purpose of the course The course aims to provide an overview of the basic principles as well as the design, conduct and ethical aspects of clinical trials. The overall purpose is to provide the PhD student with knowledge to understand how clinical trials need to be performed and to gain insight on how to review reports of clinical trials results. Furthermore, it aims to enable the PhD student to earn powerful tools to use in future projects and planning of trials. In addition, the PhD student will be able to design studies with a strong translational focus.
Intended learning outcomes At the end of the course the students need to be able to show
- a thorough understanding of the basic principles of clinical trials
- the ability to discuss and understand the most common trial designs and appraise reports of other trials.
- to understand and be able to debate on potential ethical aspects of clinical trials
Contents of the course This course is a basic introduction to design, conduct and assessment of clinical trials and it is recommended to all PhD students within basic, epidemiologic and clinically oriented research fields. The course will describe different trial designs, strengths and pitfalls and practical issues when planning and conducting translational studies in various medical disciplines. Discussion on basic principles of reporting translational trials, good clinical practice, regulatory affairs and ethics.
Teaching and learning activities The course consists of lectures, group seminars and individual work. Field visit at clinical and translational research facilities.
Compulsory elements All seminars and demonstrations are compulsory, also some specified key lectures, as well as the written examination.
Single missed occasions can be compensated for with an additional task during the course after discussion with the course director.
Examination To pass the course the students must show that they have reached the learning outcomes of the course.
This will be assessed by a written individual examination with a focus on understanding of concepts,
principles, practical and ethical issues of clinical trials.
Literature and other teaching material Clinical trials, A practical guide to design, analysis and reporting. Duolao Wang, Ameet Bakhai. Remedica 2005
Clinical and translational science. Principles on human research. David Robertson, Gordon Williams. 2nd edition. Elsevier 2017.
The students will be provided with relevant research papers and other material prior and during the course.
Number of students 10 - 20
Selection of students Selection will be based on 1) the relevance of the course syllabus for the applicant's doctoral project (according to written motivation), 2) date for registration as a doctoral student (priority given to earlier registration date).
More information The course will be held daily within the span of one week, from Monday to Friday 09:00-16:00.
Additional course leader Antroula Papakonstantinou
Latest course evaluation Not available
Course responsible Alexios Matikas
Institutionen för onkologi-patologi

alexios.matikas@ki.se
Contact person Antroula Papakonstantinou
Institutionen för onkologi-patologi

antroula.papakonstantinou@ki.se