Course catalogue doctoral education - VT24

  • Ansökan kan ske mellan 2023-10-16 och 2023-11-15
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Title Study Design in Clinical Research
Course number 2980
Programme 0-Inte del av forskarutbildningsprogram
Language English
Credits 3.0
Date 2023-11-06 -- 2023-11-23
Responsible KI department Institutionen för molekylär medicin och kirurgi
Specific entry requirements
Purpose of the course The purpose of the course is to present an overview over study designs employed in clinical research, to explain why and how to write a study protocol, and to critically reflect on protocols’ content.
The course is ideal for doctoral students that are going to conduct clinical research.
Intended learning outcomes At the end of the course the students should be able to: 1) Independently plan and produce a study protocol, including a thorough methodological evaluation and choice of appropriate study design; 2) Critically reflect on other students' individual project work in a scientifically constructive way; 3) Interpret and critically evaluate scientific studies relevant to the course content.
Contents of the course 1) Basic terms in epidemiology and clinical study design; 2) Measures of disease occurrence; 3) Observational studies, including cohort and case-control studies; 4) Systematic and random errors; 5) Experimental studies, including randomised clinical trials; 6) Quality of life in clinical research; 7) Screening and diagnosis in relation to clinical research. Throughout the course the students will work on an individual project (examination 1) for peer-review (examination 2) and the students will critically review and discuss relevant scientific articles (examination 3).
Teaching and learning activities Lectures, individual article review, group discussions, and homework tasks. The course focuses on active learning, i.e., putting knowledge into practice and critically reflecting upon the knowledge, rather than memorising facts. Therefore, much of the focus of the course is on the individual project where students are required to develop a full study protocol including several important aspects covered in the lectures, article reviews and group discussions. Students will peer-review each other's projects during the examination.
Compulsory elements Compulsory attendance includes the scheduled lectures and seminars all held during the first week of the course. Absence will need to be replaced by individual assignments following discussion with the course co-ordinator, e.g., article reviews, with written or oral follow-up.
Examination 1) Individual project work: Develop a written comprehensive yet concise study protocol including several important aspects of study design discussed during the course; 2) Peer-review of other students' projects followed by oral presentation of their project and opposition of other students projects during the group examination; 3) Critically review scientific articles relevant to the course content and participate actively to the discussions. To pass the course the student should show that all intended learning outcomes have been reached.
Literature and other teaching material Mandatory:
Kenneth J Rothman ""Epidemiology -an introduction"" (2012) Oxford University Press, USA.
Scientific articles (handed out during course).

Fayers PM, Machin D. Quality of life: the assessment, analysis and reporting of patient-reported outcomes. John Wiley & Sons; 2015 Nov 23.
Number of students 20 - 25
Selection of students Selection will be based on 1) the relevance of the course syllabus for the applicant's doctoral project (according to written motivation), 2) date for registration as a doctoral student (priority given to earlier registration date)
More information The course will take place during a 3-week period, at Karolinska Institutet, Solna unless restriction due to the Covid-19 pandemic requires the course to be held online. Lectures and group works are scheduled during the first 4 days of the first course week. The oral exam will take place at the end of the third week (Thursday). The course entails 3 credits, requiring two weeks of fulltime work, which in addition to the lectures and group works includes individual work on the study protocol. The lecturers are active clinical researchers and/or professors.
Additional course leader
Latest course evaluation Course evaluation report
Course responsible Giola Santoni
Institutionen för molekylär medicin och kirurgi
Contact person Kalle Mälberg
Institutionen för molekylär medicin och kirurgi