Kurskatalog forskarutbildning - VT22

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Titel Clinical Trials in Heart Failure Research
Kursnummer 5307
Program Kardiovaskulär forskning
Språk Engelska
Antal högskolepoäng 1.5
Datum 2021-09-30 -- 2021-10-05
Kursansvarig institution Institutionen för medicin, Solna
Särskild behörighet Epidemiology I and Biostastics I or equivalent knowledge
Kursens syfte To enable students to learn the principles of study designs and data analyses/interpretation for clinical trials in heart failure.
Kursens lärandemål 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
Kursens innehåll 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
Arbetsformer 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
Obligatoriska moment 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.
Kurslitteratur och övriga läromedel Recommended reading material + ppt presentations will be provided on the course platform well in advance of the course.
Antal studenter 5 - 20
Urval av studenter 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)
Övrig 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.
Ytterligare kursledare
Senaste kursvärdering Not available
Kursansvarig Gianluigi Savarese
Institutionen för medicin, Solna

gianluigi.savarese@ki.se
Kontaktpersoner -