The Fundamentals of Randomized controlled trials
Graduate School of Health and Medical Sciences at University of Copenhagen
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 faculties. 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. Explain the fundamental concepts and methodologies of randomized controlled trials.
2. Describe the importance and benefits of randomization in clinical research.
3. Recognize key design elements that influence the validity and reliability of trial results.
4. Assess factors such as blinding, allocation concealment, and sample size determination.
5. Analyze and provide constructive feedback on the design and execution of trials.
6. Apply learned principles to assess the quality and reliability of various trial designs.
7. Gain a better understanding of how to obtain regulatory approval and maintain continuous collaboration with regulatory authorities.
8. Engage in professional networking opportunities with peers, regulatory representatives, statisticians, and experienced trialists.
Content
The first day will consist of presentations on the fundamentals of randomized trials, including group work and discussions. The day will conclude with a master class on trial-related statistics.
The second day will feature lectures by invited national and international experienced trialists, focusing on previous methodological challenges, learnings, and experiences from their conducted trials, with Q&A sessions. In the second part of the day, participants will be divided into groups of course participants and an experienced trialist. Each PhD student will prepare a presentation, up to 3 minutes long, with slides or a digital poster on their planned or ongoing study in the PICO format, focusing on methodological challenges. These presentations will be followed by discussions led by one of the invited speakers. The day will end with a dinner at a nearby restaurant for the study participants, teachers, and organizers.
The final day will include talks on the regulatory and ethical aspects of conducting clinical trials, from both the regulatory and PhD student perspectives.
Participants
PhD students within health science interested in, planning, or already conducting randomized controlled trials or other studies.
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, group work, discussions, prepared student presentations.
Course director
Tor Biering-Sørensen, MD, MPH, MSc, 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
• Louise Bowman, BA, MBBS, MD, FRCP. Professor of Medicine and Clinical Trials. The Clinical Trial Service Unit (CTSU) of the University of Oxford
• Anders Perner, MD, PhD, Professor of Intensive Care. Department of Intensive Care, Centre for Cancer and Organ Diseases and University of Copenhagen.
• Brian Claggett, PhD. Associate Professor and chief statistician. Harvard Medical School and Clinical Trials Outcomes Center (CTOC) at Brigham and Women’s Hospital.
• Søren Hardt-Lindberg, MD, PhD. Project Vice President, Novo Nordisk, Clinical Drug Development, Cardiovascular Unit.
• Caroline Espersen, MD. PhD-student. Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen.
• Manan Pareek, MD, PhD. Senior researcher. Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen.
• Maria Dons, MD. PhD-student. Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen.
• Niklas Dyrby Johansen, MD. PhD-student. Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen.
• Tor Biering-Sørensen, MD, MPH, MSc, PhD. Professor and Director. Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen.
• Additional invited speakers will be announced, when confirmed.
Dates
16-18 December 2024
Course location
Panum
Registration
Please register before 10 November 2024
Expected frequency
Annual
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.