Course catalogue doctoral education - HT17

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Title Study design in clinical research
Course number 2980
Program 0-Inte del av forskarutbildningsprogram
Language English
Credits 3.0
Date 2017-11-13 -- 2017-12-01
Responsible KI department Institutionen för molekylär medicin och kirurgi
Specific entry requirements
Purpose of the course The purpose of the course is to give the student an overview over the design and conduct of clinical research, including writing a study protocol and critically reflecting on its content.
Learning outcomes After completion 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 The course is designed for PhD-students, in particular those who are at an early stage of their research education and those with an interest in conducting clinical research. The content of the course is as follows: 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) Examination and course evaluation. 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, seminars, individual article review, group discussions, and homework tasks will be used. 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 also peer-review each other's projects and this will form the basis for the final examination seminar.
Compulsory elements Compulsory attendance includes the scheduled lectures and seminars. 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 To pass the course the student must actively participate in the course and pass the examinations: 1) Individual project work: To develop a written comprehensive yet concise study protocol including several important aspects of study design as discussed during the course; 2) Peer-review of other students' projects followed by oral presentation of own project and opposition of other students projects during the group examination; 3) Critically review scientific articles relevant to the course content and participate actively in the seminars.
Literature and other teaching material Mandatory: Kenneth J Rothman "Epidemiology -an introduction" (2012) Oxford University Press, USA. Scientific articles (handed out during course).
Number of students 18 - 25
Selection of students Preference will be given to students early on in their PhD education, who have a clinical research focus, and where the benefits of this course will be greatest. Date of registration as a PhD student, suitability of PhD project, and the motivation to attend the course given will be used in the selection process.
More information The course will take place during a 3-week period, at Karolinska Institutet, Solna. The majority of lectures and seminars are scheduled during the first 3.5 days of the first course week. There is one mandatory seminar during the second week (Friday). The oral exam will take place at the end of the third week (Friday). The course entails 3 credits, requiring 2 weeks of full-time work, which in addition to the lectures and seminars includes individual work on the study protocol. The lecturers are active clinical researchers.
Course 2980 has previously been given with course number 1794. It now gives 3 credits from earlier 4 credits. The decision to shorten the course was based on student feedback from course 1794. The evaluation report below is based on course 1794.
Course directors
Earlier evaluation of the course Evaluation report
Course responsible Eivind Ness-Jensen
Institutionen för molekylär medicin och kirurgi

eivind.ness-jensen@ki.se
Contact person Kalle Mälberg
Institutionen för molekylär medicin och kirurgi

kalle.malberg@ki.se


Eivind Ness-Jensen
Institutionen för molekylär medicin och kirurgi

eivind.ness-jensen@ki.se