Course catalogue doctoral education - HT21

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Title Clinical Trials in Heart Failure Research
Course number 5307
Programme Kardiovaskulär forskning
Language English
Credits 1.5
Date 2021-09-30 -- 2021-10-05
Responsible KI department Institutionen för medicin, Solna
Specific entry requirements Epidemiology I and Biostastics I or equivalent knowledge
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.
Number of students 5 - 20
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 September 30th: home study/distance learning using provided readings, prerecorded or live lectures on zoom. October 1st (afternoon) TO October 3rd 2021 (lunch time): frontal teaching/workshops. October 4th 2021: home study/distance learning using provided readings and prerecorded lectures. October 5th 2021 (half day): exam.

Location: Frontal teaching/workshop which will be held in SORRENTO, ITALY.

The course is run in collaboration with the Heart Failure Association (HFA) of the European Society of Cardiology, which will support the organisation of the course, provide well-known global trialists as speakers and faculty.

A Limited number of travel grants from HFA will be provided and more information will follow.
Additional course leader
Latest course evaluation Not available
Course responsible Gianluigi Savarese
Institutionen för medicin, Solna

gianluigi.savarese@ki.se
Contact person -