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Biostatistics for the design and analysis of clinical trials
Provider: Faculty of Health and Medical Sciences

Activity no.: 3350-25-00-00There are 24 available seats 
Enrollment deadline: 19/10/2025
Date and time18.11.2025, at: 08:00 - 21.11.2025, at: 15:00
Regular seats30
Course fee3,120.00 kr.
LecturersPaul Blanche
ECTS credits2.80
Contact personSusanne Kragskov Laupstad    E-mail address: skl@sund.ku.dk
Enrolment Handling/Course OrganiserPhD administration SUND    E-mail address: phdkursus@sund.ku.dk

Enrolment guidelines
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 enrolment 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. Relate key concepts in clinical trials to statistical thinking.

2. Take advice from a statistician to design a clinical trial and write a relevant statistical analysis plan.

3. Describe consensual recommendations to design and analyze clinical trials and restate their rationale.

4. Exemplify the use of different statistical methods to design and analyze clinical trials.

5. Carry out commonly used basic computation using the R software.


Content
The course introduces statistical concepts and methods to design and analyze clinical trials. An important aim of the course is to relate key concepts in clinical trials and common practice to sound statistical thinking.

We will cover "basic" topics such as randomization, blinding, power and sample calculation, as well as more advanced topics, such as covariate adjustment, robustness, missing data, sensitivity analysis and interim analyses. We will also discuss the rationale for common practices such as "intention-to-treat" and "per-protocol" analyses, as well as the modern approach to think about them: the estimand framework.

For the most basic concepts and methods, our aim is to provide the students with the necessary knowledge to use them autonomously.

For the more advanced topics, we will present the necessary concepts to prepare the students to take advice from statistical experts. References to consensual recommendations and guidelines will be provided (e.g., CONSORT, EMA, FDA). Several examples will be taken from the teacher's own experience, to facilitate thorough discussions of specific case studies. Recommendations about the writing of a Statistical Analysis Plan will also be presented.


Participants
The course is tailored for Ph.D.-students in health sciences who already have taken the Ph.D.-course "Basic Statistics for Health Researchers" or "Statistics for experimental medical researchers" or have a similar knowledge about both statistical thinking and R coding.

Students with a more limited background are expected to benefit from the course too, but to a lesser extent.


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
3 hr forum lectures and 3 hr exercise classes per day for four days. Attending 7 out of the 8 half days is required to pass the course.


Course director
Paul Blanche, associate professor, Section of Biostatistics, Dept. of Public Health, UCPH


Teachers
Paul Blanche, associate professor, Section of Biostatistics, Dept. of Public Health, UCPH


Dates
18, 19, 20, 21 November 2025, all days 8-15


Course location
CSS, Center for Sundhed og Samfund


Registration
Please register before 19 October 2025


Expected frequency
Once a year.


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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