Syllabus database for doctoral courses
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Syllabus database for doctoral courses
SYLLABI FOR DOCTORAL COURSES
| Swedish title | Kliniska prövningar vid forskning om hjärtsvikt |
|---|---|
| English title | Clinical Trials in Heart Failure Research |
| Course number | 5307 |
| Credits | 1.5 |
| Responsible KI department | Institutionen för medicin, Solna |
| Specific entry requirements | Epidemiology I and Biostastics I or equivalent knowledge |
| Grading | Passed /Not passed |
| Established by | The Committee for Doctoral Education |
| Established | 2021-03-30 |
| Purpose of the course | To enable students to learn the principles of study designs and data analyses/interpretation for clinical trials in heart failure. |
| Intended learning outcomes | At the end of the course, the participants are supposed to be able to:
- choose the adequate trial design to conduct an interventional study - apply important ethical principles while designing a clinical trial - design a clinical trial which satisfies the requirements of the regulatory agencies - choose and use key statistical methods for running randomized controlled trials and meta-analyses of randomized controlled trials - critically interpret data from randomized controlled trials and meta-analyses of randomized controlled trials |
| Contents of the course | The lectures will cover:
1) Key elements in randomized controlled trials design: methods for randomization; differences between superiority and non-inferiority trials; different types of endpoint analysis (e.g. first to time event vs. recurrent event analysis), interpretation of subgroup analyses 2) Novel randomized controlled trial design: registry based randomized controlled trials, adaptive, basket & umbrella & platform designs 3) Key aspects differentiating randomized controlled trials from registry-based studies 4) Systematic Reviewers and Meta-analyses of randomized controlled trials: different designs and main methods The “Hands-on” workshops will consider: 1) Power and sample size calculations 2) Survival analysis including competing, recurrent event analysis, interaction analysis 3) Key statistical methods for meta-analysis 4) Adjusting and matching in registry-based studies (e.g. propensity score): how to run it and why it does not replace randomization |
| Teaching and learning activities | The course will consist of:
- two and half days distance learning via Zoom or using prerecorded lectures and provided readings - two days on-site lectures/workshops - half day: exam The formats of course activities include: - Distance learning with critical readings of course literature - On-site lectures/seminars - Debates on relevant clinical trials - Workshops - Group work |
| Compulsory elements | Participants should attend all the sessions and the exam to pass the course.
The students who have missed course sessions will be assigned extra reading and home work to compensate for the absence. |
| Examination | Home-based assignment including open questions and multiple choice questions. All learning outcomes of the courses need to be achieved to pass the course. |
| Literature and other teaching material | Recommended reading material + ppt presentations will be provided on the course platform well in advance of the course. | Course responsible |
Gianluigi Savarese Institutionen för medicin, Solna gianluigi.savarese@ki.se |
| Contact person |
