Graduate School of health and Medical Sciences

The Fundamentals of Randomized controlled trials
Provider: Faculty of Health and Medical Sciences

Activity no.: 3346-23-00-00
	Enrollment deadline: 20/11/2023

Date and time	21.12.2023, at: 08:30 - 22.12.2023, at: 16:00
Regular seats	50
Course fee	2,400.00 kr.
Lecturers	Tor Biering-Sørensen
ECTS credits	1.60

Contact person	Arnela Saljic E-mail address: arnela@sund.ku.dk

Enrolment Handling/Course Organiser	PhD administration E-mail address: phdkursus@sund.ku.dk

Aim and content This is a generic course. This means that the course is reserved for PhD students at the Graduate School of Health and Medical Sciences at UCPH. Anyone can apply for the course, but if you are not a PhD student at the Graduate School, you will be placed on the waiting list until enrollment deadline. After the enrollment deadline, available seats will be allocated to the waiting list. The course is free of charge for PhD students at Danish universities (except Copenhagen Business School), and for PhD students at NorDoc member universities. All other participants must pay the course fee. Learning objectives A student who has met the objectives of the course will be able to: 1. Articulate the principles of randomized trials 2. Explain the relevance of observational data when estimating effect size 3. Identify the design factors that impact on the reliability of results 4. Identify the key components of a trial 5. Apply/propose and defend an appropriate recruitment strategy Content The course will run over two full days. The first one and a half days will consist mainly of lectures on the principles of randomized trials, with the final half day focusing on interaction with invited experienced trialists. The aim of the course is to provide trainees with a solid introduction to the planning and conduction of randomized controlled trials and is targeted at PhD students who are in the process of developing randomized controlled trials. Participants PhD students within health science planning or already conducting randomized controlled trials. Relevance to graduate programmes The course is relevant to PhD students from the following graduate programmes at the Graduate School of Health and Medical Sciences, UCPH: - All graduate programmes Language English Form Lectures, discussions Course director Tor Biering-Sørensen, MD, MPH, PhD Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen. Head of Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte. E.mail: tor.biering-soerensen@regionh.dk / tor.biering.sorensen@alumni.harvard.edu / tobs@sund.ku.dk Teachers Tor Biering-Sørensen (Center for Translational Cardiology and Pragmatic Randomized Trials) Kristoffer Grundtvig Skaarup (Center for Translational Cardiology and Pragmatic Randomized Trials) Manan Pareek (Center for Translational Cardiology and Pragmatic Randomized Trials) Caroline Espersen (Center for Translational Cardiology and Pragmatic Randomized Trials) Katja Vu (Center for Translational Cardiology and Pragmatic Randomized Trials) Niklas Johansen (Division of Cardiovascular Medicine, Brigham and Women’s Hospital. Center for Translational Cardiology and Pragmatic Randomized Trials) Kasper Bendix (Section for Research Ethical Evaluation at the Danish National Center for Ethics) Frederik Nørgaard (Clinical Trials, Danish Medicines Agency) Birgitte Hansen (GCP-unit, Region Hovedstaden) Brian Claggett (Division of Cardiovascular Medicine, Brigham and Women’s Hospital & Harvard Medical School) Søren Hardt-Lindberg (Novo Nordisk) Christian Hassager (Dept. Cardiology, Rigshosptialet & Copenhagen University) Jens-Ulrik Stæhr Jensen (Division of Respiratory Medicine, Gentofte Hospital & Copenhagen University) Richard Haynes (Oxford University) Dates 21-22 December 2023 Course location Mærsk Tårnet Registration Please register before 20 November 2023 Seats to PhD students from other Danish universities will be allocated on a first-come, first-served basis and according to the applicable rules. Applications from other participants will be considered after the last day of enrolment. Note: All applicants are asked to submit invoice details in case of no-show, late cancellation or obligation to pay the course fee (typically non-PhD students). If you are a PhD student, your participation in the course must be in agreement with your principal supervisor.

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