Course catalogue doctoral education - VT24

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Title Clinical Trials in Cardiovascular Research
Course number 3173
Programme Kardiovaskulär forskning
Language English
Credits 1.5
Date 2024-01-15 -- 2024-01-19
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements
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.
Number of students 8 - 30
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) start date of doctoral studies (priority given to earlier start date)
More information January 15th and 16th: frontal teaching/workshops. January 17th and 18th: home study and preparation of the exam in groups of 4/5 students (home-based). January 19th: exam. Location: Karolinska University Hospital/Karolinska Institutet, Solna.
Additional course leader Giulia Ferrannini - Division of Cardiology, Department of Medicine Solna, Karolinska Institutet.
Latest course evaluation Course evaluation report
Course responsible Gianluigi Savarese
Institutionen för medicin, Solna

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

giulia.ferrannini@ki.se