SPMM21004U Evidence Based Clinical Application of Personalised Medicine
This course is offered as part of the Master in Personalised
Medicine.
The master's program is continuing education for health
professionals.
The Master of Personal Medicine has been developed in close
collaboration between the four faculties of health sciences at
University of Copenhagen, Aarhus University, Aalborg University and
the University of Southern Denmark as well as the Technical
University of Denmark. In this way, we ensure that you are taught
by national experts from internationally recognized research
environments in Denmark.
Read more about the programme on the website:
www.personligmedicin.ku.dk
Implementation of personalised medicine represents the potential
for a paradigm shift in disease prevention and treatment, based on
optimizing individualised intervention. gain knowledge on how to
ensure that that the usefulness of this evidence is maintained over
time, after its clinical application is introduced into everyday
clinical settings across the health care system.
You will be introduced to the varying degrees of evidence-building,
and how the scientific findings can be internally and externally
validated.
Innovative approaches to obtaining evidence are discussed, with a
special focus on the unique challenges that a personal medicine
approach has, as opposed to traditional evidence-building, by the
study of groups of patients.
Approaches to quantifying the beneficial effect of these
interventions, and any unintended consequences, are elucidated.
You will gain insight into the required investments and the
existing legal challenges pertaining to the implementation and
maintenance of such interventions in the operational part of the
healthcare system.
The course consists of 5 main themes:
1. Why do all patients with an illness not benefit from the same
effect of a certain medicine?
- Evidence creation
- Phenotypes: syndrome vs. disease vs. biomarker vs. individual health status
- Effect and side effect at group level vs. the individual level
- The causal reasons for illness
- Experience with well-meaning, but erroneous conclusions about using interventions that actually did not help
2. Creation of evidence for new medicines
- RCTs: Phases before and after regulatory approval
- Surrogate marker for effect
- Stratification of risk
- Effectiveness: relative vs. absolute
- Investigator vs. industry initiated studies
- Rare illness and evidence creation
- N=1 studies
- Multi-arm-multi-stage and other flexible designs
- Observational studies: correlation and causality
3. Strategic questions as opposed to A vs. B
- Early vs. late intervention
- More vs. less intervention
- New vs. established intervention
4. Draw from electronic knowledge in a specific clinical
situation
- Patient-like-me
- Operation (drift?) in data quality can affect knowledge - and how is it counteracted
- Authorities and hospital governance
- Who is responsible if electronic knowledge is misleading?
5. Cost-effective treatment
- The basic concepts and how they are calculated
- Prioritization: Gains for the individual and for society
- Prioritization: Who decides what is best? The doctor or the economist?
- Ethics: Do the best for the individual vs. what society can afford
Knowledge
- Be able to describe approaches to the development of evidence for medical interventions in patient care
- Be able to discuss the unique challenges in obtaining this evidence in connection with personalised medicine, rather than the traditional evidence approach of groups of patients, as well as explain innovative approaches to dealing with these challenges
- Be able to explain, in connection with the implementation of new interventions based on automated computer science, how to separate interventions where evidence of usefulness already exists (and where the automation therefore aims to optimize workflows) from interventions where the evidence base is not sufficiently substantiated
- Be able to describe approaches and pitfalls in the introduction and maintenance of the clinical quality of new interventions based on automated computer-generated information. Both in terms of clinical value as well as legal division of responsibilities
- Be able to account for the quantification of the clinically beneficial conditions of new interventions in relation to the necessary public investments
Competencies
- Be able to identify the opportunities and challenges in one's own department / own subject area that are important for the development of personalised medicine
- Be able to plan research, development, validation and implementation of clinical evidence for interventions based on personalised medicine
- Be able to seek out and apply the latest scientific literature on these matters
Skills
- Be able to analyze and critically approach the construction of clinical evidence by using personalised medicine in the health care system
- Be able to communicate knowledge about these relationships to patients, colleagues and other professional groups
Articles and selected readings.
Reading list can be found on Absalon.
- Teaching and group work on project
Expect significant preparation time for all parts of the course. Between the three attendance periods there will be self-study and group work.
- Category
- Hours
- Lectures
- 6
- Class Instruction
- 12
- Preparation
- 135
- Project work
- 35
- Exam
- 18
- Total
- 206
Read more about application requirements on the
programme homepage. Please note that the
master in Personalised Medicine is a Danish
master programme.
This module can be taken as a single course to external
participants who meet the admission requirements. Read more
about the admission requirements and apply via
the course homepage.
- Credit
- 7,5 ECTS
- Type of assessment
- Written assignmentOral examination
- Type of assessment details
- The exam consists of a written course assignment followed by an
oral examination. The assignment is written in continuation of the
course teaching and can be prepared individually or in groups.
The scope of the exam paper is: 8 pages, if you write alone; 12 pages, when two to three, who write together; 16 pages if you are four who write together. One page is defined as 2400 number of characters (including spacing). That means, if one person writes the assignment it will be 19.200 characters; 28.800 characters if two-three people write together; 38.400 characters if four people write together.
At the oral exam, the exam paper is presented followed by verbal examination of its content.
Time for oral examination:
1 person: 20 minutes
Group of 2 people: 30 minutes
Group of 3 people: 40 minutes
Group of 4 people: 50 minutes - Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
More than one internal examiner
- Exam period
See information about exam time in the exam plan. The exam plan is published on this website: https://sund.ku.dk/uddannelse/studieinformation/eksamensplaner/- Re-exam
The exam form for the reexam is the same as the ordinary exam.
See information about re-exam time in the exam plan. The exam plan is published on this website: https://sund.ku.dk/uddannelse/studieinformation/eksamensplaner/
Criteria for exam assesment
To acheive the grade 12, the student must:
Knowledge
- Be able to describe approaches to the development of evidence for medical interventions in patient care
- Be able to discuss the unique challenges in obtaining this evidence in connection with personalised medicine, rather than the traditional evidence approach of groups of patients, as well as explain innovative approaches to dealing with these challenges
- Be able to explain, in connection with the implementation of new interventions based on automated computer science, how to separate interventions where evidence of usefulness already exists (and where the automation therefore aims to optimize workflows) from interventions where the evidence base is not sufficiently substantiated
- Be able to describe approaches and pitfalls in the introduction and maintenance of the clinical quality of new interventions based on automated computer-generated information. Both in terms of clinical value as well as legal division of responsibilities
- Be able to account for the quantification of the clinically beneficial conditions of new interventions in relation to the necessary public investments
Competencies
- Be able to identify the opportunities and challenges in one's own department / own subject area that are important for the development of personalised medicine
- Be able to plan research, development, validation and implementation of clinical evidence for interventions based on personalised medicine
- Be able to seek out and apply the latest scientific literature on these matters
Skills
- Be able to analyze and critically approach the construction of clinical evidence by using personalised medicine in the health care system
- Be able to communicate knowledge about these relationships to patients, colleagues and other professional groups
Course information
- Language
- English
- Course code
- SPMM21004U
- Credit
- 7,5 ECTS
- Level
- Part Time Master
- Duration
- 1 semester
- Placement
- Autumn
- Schedule
- Please visit the homepage to find information on course days, structure and exam: https://personligmedicin.ku.dk/kursus/
- Course capacity
- 30
Price
Price for EU/EAA applicants: DKK 15.000
Price for Non EU/EAA applicants: DKK 20.600
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Clinical Medicine
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Jens Lundgren (jens.lundgren@regionh.dk)
Lecturers
Course Director Jens Lundgren
Professor of Infectious Diseases, Chief Physician, Dr.med.,
Department of Clinical Medicine, University of Copenhagen.
Centre leader, Centre of Excellence for Personalised Medicine of
Infectious Complications in Immune Deficiency (PERSIMUNE), Danish
National Research Foundation, Rigshospitalet.