course-details-portlet

KLMED8009 - Clinical Research

About

Examination arrangement

Examination arrangement: Written examination
Grade: Passed/Failed

Evaluation form Weighting Duration Examination aids Grade deviation
Written examination 100/100 4 hours D

Course content

The course consists of three parts, 3 + 2 + 2 days, usually in the beginning of September, October and November. The course is focusing on Randomized Controlled Trials (RCTs) and will cover all the important aspects of RCTs, from design to reporting. Particular emphasis will also be placed upon practical aspects. Recent advances in RCT methodology will be covered. Other research designs will also be presented with focus on strengths and limitations. Protocol design will be covered with focus on background, eligibility criteria, randomization, sample size, outcome measures, procedures for participants, monitoring, reporting and analysis, and publication policy. A short introduction/repetition of basic statistics will focus on significance tests, confidence intervals, p-values and sample size estimation. Fraud, bias and confounding will be discussed. The course also covers the use of clinical measurements and studies on diagnostic tests, including precision, accuracy, validity, specificity, sensitivity, reproducibility, feasibility, appropriateness and how to interpret the results in a clinical setting. Further, the course will focus on Patient Reported Outcomes (PRO). Worldwide there is an increasing demand to always consider measurements of PRO in new clinical trials. Measurements of PRO and subjective symptoms are generally important, but particularly important in studies of palliative care. The course will cover several aspects of these measurements in randomized studies and clinical trials; choice of questionnaire, methods, study design, problem solving, analysis and comprehension of the data, report of results and conclusions. The course will also focus on how to read and interpret papers with focus on how to evaluate the scientific quality, i.e. should the results be trusted or not. An important part of this is homework with a written evaluation of selected papers. Having taken the course participants should be able to evaluate the work of others as well as to plan, execute and report their own clinical studies according the highest scientific standards.

Learning outcome

After completing the course, the student is:
- able to assess the expediency and application of the different designs in clinical research including more sophisticated designs
- able to contribute to the improvement of designs and methods in clinical research
- by a given hypothesis able to formulate research questions in accordance with the different types of design
- with the correct methods able to design, implement, analyze and publish clinical research on an international level
- able to identify research questions related to design and carry out research with a methodical integrity
- able to communicate clinical research and development through acknowledged national and international channels
- able to select and use methods of patient reported outcome
- able to use methods for relevant literature search
- able to evaluate the quality of clinical research papers according to research methods used

Learning methods and activities

Lectures, group work, home assignment.
To be allowed to take the examination all homework must be delivered on time and at least 80% attendance of the lectures is mandatory.

Compulsory assignments

  • Paper/excercise before written exam
  • All lectures

Further on evaluation

If retake of the examination this can be either by a written or an oral test. This is to be deceided by the person responsible for the course.

Specific conditions

Exam registration requires that class registration is approved in the same semester. Compulsory activities from previous semester may be approved by the department.

Required previous knowledge

Master degree or similar. Medical students at The Student Research Programme. Candidates with a lower degree will be assessed individually.

Course materials

Stephen B Hulley et al. Designing Clinical Research (fourth edition)
Forlag: Lippincott Williams & Wilkins: 2013. ISBN: 978-1-60831-804-9.

David Machin & Peter Fayers. Randomized controlled trials. Design, practice and reporting. Forlag: Wiley-Blackwell 2009/2010. ISBN-10: 0471498122. ISBN-13: 978-0471498124.

Credit reductions

Course code Reduction From To
KLMED8003 4.0 01.09.2012
KLMED8007 5.0 01.09.2012
More on the course

No

Facts

Version: 1
Credits:  7.5 SP
Study level: Doctoral degree level

Coursework

Term no.: 1
Teaching semester:  AUTUMN 2020

Language of instruction: English

Location: Trondheim

Subject area(s)
  • Clinical Medicine
  • Medicine
Contact information
Course coordinator: Lecturer(s):

Department with academic responsibility
Department of Clinical and Molecular Medicine

Phone:

Examination

Examination arrangement: Written examination

Term Status code Evaluation form Weighting Examination aids Date Time Digital exam Room *
Autumn ORD Written examination 100/100 D
Room Building Number of candidates
Spring UTS Written examination 100/100 D
Room Building Number of candidates
  • * The location (room) for a written examination is published 3 days before examination date. If more than one room is listed, you will find your room at Studentweb.
Examination

For more information regarding registration for examination and examination procedures, see "Innsida - Exams"

More on examinations at NTNU