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SYLLABI FOR DOCTORAL COURSES

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Swedish title Kliniska prövningar inom kardiovaskulär forskning
English title Clinical Trials in Cardiovascular Research
Course number 3173
Credits 1.5
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements
Grading Passed /Not passed
Established by The Committee for Doctoral Education
Established 2023-02-13
Purpose of the course To enable doctoral students to:
-Improve their knowledge and skills related to clinical trial planning and design as well as successful running of different types of clinical trials (observational studies,registries, randomized trials);
-Acquire an overview of some recent key trials in the cardiovascular arena.
Intended learning outcomes After the course, the participants should be able to:
-design a clinical trial
-account for the relevant regulatory aspects involved in the process of designing and running a clinical trial
-analyze and interpret trial data
-critically review literature of clinical trials
-handle important statistical issues (e.g. different types of adjustments for confounders, biases, how to perform subgroupanalysis in trials, statistical methods for meta-analyses) related to different trial designs (e.g. observational studies,registries, randomized trials and meta-analyses).
Contents of the course Lectures/Workshops on the following topics:
-Different designs of clinical trials
-Requirements from regulatory agencies and post marketing surveillance
-Upcoming and ongoing cardiovascular clinical trials
-Statistical issues in clinical trials
-How to interpret clinical trials
Teaching and learning activities - Lectures/workshops, debates on important clinical trials (2 days)
- Home-based studying and preparation of the exam - group work (2 days)
- Presentation and discussion of your own design of a clinical trial (1 day)
Compulsory elements Participants should attend all the sessions and be involved in group work and presentation of the home assignment. The students who have missed course sessions will be assigned extra-reading and home work to compensate the absence.
Examination Home-based group assignment (design of a clinical trial on a topic of students' choice) which will be presented/discussed on the examination date. Each individual will be assessed on the basis of the achievement of the intended learning outcomes of the course.
Literature and other teaching material Recommended reading materials will be provided well in advance of the course.
Course responsible Gianluigi Savarese
Institutionen för medicin, Solna


gianluigi.savarese@ki.se
Contact person Giulia Ferrannini
Institutionen för medicin, Solna


giulia.ferrannini@ki.se