Course catalogue doctoral education - VT20

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Title Clinical Trials in Cardiovascular Research
Course number 3173
Programme Kardiovaskulär forskning
Language English
Credits 1.5
Date 2019-12-05 -- 2019-12-11
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 should:
- be able to know how to design, plan and run a successful clinical trial
- be able to account for the relevant regulatory aspects involved in the process of designing and running a clinical trial
- be able to analyze and interpret trial data
- be able to critically review literature of clinical trials
- be familiar with 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 the absence
Examination Assigned clinical trial design and oral presentation/discussion of a home assignment
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) date for registration as a doctoral student (priority given to earlier registration date)
More information December 5th and 6th 2019: frontal teaching.
December 9th and 10th: course assigned work and preparation of the exam in groups of 4 students (home-based).
December 11th: 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.
Additional course leader
Latest course evaluation Not available
Course responsible Gianluigi Savarese
Institutionen för medicin, Solna

gianluigi.savarese@ki.se
Contact person -