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Challenges in the RCT – focus on patient selection and PROs
Provider: Faculty of Health and Medical Sciences

Activity no.: 3483-24-00-00 
Enrollment deadline: 16/04/2024
Date and time25.04.2024, at: 08:45 - 26.04.2024, at: 16:05
Regular seats25
Course fee3,480.00 kr.
LecturersIsmail Gögenur
ECTS credits1.50
Contact personAnne Dalsgaard Hansen    E-mail address: adha@regionsjaelland.dk
Enrolment Handling/Course OrganiserPhD administration     E-mail address: phdkursus@sund.ku.dk

Aim and content
This course is free of charge for PhD students at Danish universities (except Copenhagen Business School), and for PhD Students from NorDoc member faculties. All other participants must pay the course fee.

Anyone can apply for the course, but if you are not a PhD student at a Danish university, you will be placed on the waiting list until enrollment deadline. This also applies to PhD students from NorDoc member faculties. After the enrollment deadline, available seats will be allocated to applicants on the waiting list.

Learning objectives
A student who has met the objectives of the course will be able to:

1. Understand the design of Randomized clinical trials and identify crucial points in design selection

2. Gain in depth insight into how to perform patient selection when designing an RCT within the surgical field

3. Understand the variation in designs depending on the use of translational methodologies or proxies for clinical outcomes

4. Use patient reported outcomes (PRO) in RCT’s

5. Get a thorough understanding of the use of generic or disease specific PROs.

In this PhD course, the focus will be to provide the PhD student with interest in study methodologies across medical, surgical and anesthetis trials and a deep understanding of some of the crucial aspects in the Randomized Clinical Trial. There will be thorough presentations from leading national and international experts on topics regarding patient selection and patient reported outcomes. The first day will have focus on aspects concerning selection of patients while the second day on PRO's. The presenters will all be active senior researchers with long time experience within performing clinical research, and in addition we will also have patient representation.

Before the course, the PhD students will send an abstract of their current PhD study protocol and during the two days the student will be both joining the plenary presentations and participate actively in group work with subsequent plenary presentations from some of the students. All this will be while having access to the course teachers and presenters. Before the course, the students will be provided with essential reading material and they will join a pre-course online meeting in order to have the optimal preperation and insight into the course specifics.

The targeted group of this course is PhD students that are involved in research in clinical trials utilizing the randomized clinical trial approach and who is interested in understanding selection of outcomes and their impact on study design. PhD students with special interest in clinical research methodologies. A major emphasis is placed on understanding the aspects of designing randomized clinical trials with the subtopics of patient selection and PRO's.

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

Surgical Sciences

Airways, Anesthesiology and Skin


Lectures, group work, plenary presentations

Course director
Ismail Gögenur, Professor, Institute for Clinical Medicine, igo@regionsjaelland.dk
Lisbet Rosenkrantz Hölmich, Professor, Institute for Clinical Medicine, lisbet.rosenkrantz.hoelmich@regionh.dk
Preben Homøe, Professor, Institute for Clinical Medicine, prho@regionsjaelland.dk
Michael Kjær, Professor, IKM, BBH
Charlotte Suppli Ulrik, Professor, IKM, HVH

Janus Christian Jakobsen, Professor, IRS, SDU
Ismail Gögenur, Professor, IKM, SUH
Lisbet Rosenkrantz Hölmich, Professor, IKM, HGH
Preben Homøe, Professor, IKM, SUH
Lina Holm Ingelsrud, MD, PHD, HVH
Karl Bang Christensen, Professor, IFSV, KU
Sue Blackwell, PPI representative, UK

25 and 26 April 2024

Course location
Scandic Sydhavnen, Sydhavns Plads 15, 2450 København SV

Please register before 16 April 2024.

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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