Course catalogue doctoral education - VT21

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Title Clinical Trials in Cardiovascular Research
Course number 3173
Programme Kardiovaskulär forskning
Language English
Credits 1.5
Date 2020-12-10 -- 2020-12-16
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements
Purpose of the course - Improve 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);
- Provide an overview of the most recent trials in the cardiovascular arena;
- Provide Good Clinical Practice (GCP) training (certificate included for those who pass)
Intended learning outcomes After the course, the participants will know:
- important aspects about how to design, plan and run a successful clinical trial
- relevant regulatory aspects involved in the process of designing and running a clinical trial
- important elements about how to analyze and interpret trial data
- how to critically review literature of clinical trials
- important statistical issues (e.g. different types of adjustments for confounders, biases, how to perform subgroup analysis 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/Seminars/Workshops on the following topics:
- Different designs of clinical trials
- Requirements from regulatory agencies and post marketing surveillance
- Upcoming and ongoing cardiovascular clinical trials (e.g. antithrombotics, lipidology, diabetes, heart failure)
- GCP training
- Statistical issues in clinical trials
- How to interpret clinical trials
- Things to know for junior investigators
Teaching and learning activities - Lectures/Seminars
- Debates on important clinical trials
- Workshops
- Group work
- Presentation and discussion of an ""home-designed"" clinical trial
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 for 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 intended learning outcomes of the course.
Literature and other teaching material Recommended reading material will be provided.
Number of students 8 - 50
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 December 10th and 11th 2020: frontal teaching/workshops. December 14th and 15th: home study and preparation of the exam in groups of 4/5 students (home-based). December 16 th: exam. Location: Karolinska University Hospital or Karolinska Institutet, Solna. The course is run in collaboration with the European Society of Cardiology - Working Group on Cardiovascular Pharmacotherapy, which will provide well-known global trialists as speakers. National experts on cardiovascular clinical trials will also be part of the team of teachers.
Additional course leader
Latest course evaluation Course evaluation report
Course responsible Gianluigi Savarese
Institutionen för medicin, Solna

gianluigi.savarese@ki.se
Contact person -