FRM9730 – Clinical Drug Trials
Course description
Course content
The objective of the course is to provide the students with an understanding of the framework surrounding the clinical testing of medicine. The participants are to receive insight into the different clinical trial phases, test methodology, testing ethics, quality assurance, as well as how to evaluate results and statistical evaluations.
Learning outcome
The course will give the participants knowledge of guidelines and other relevant documents associated with execution of clinical trials. The participants will get an overview of the different trial phases, research methology, ethical considerations, quality assurance, evaluation of results and statistical methods used in clinical trials.
You will learn basic aspects of clinical trials with regards to study design, ethical considerations, safety reporting, GCP (Good Clinical Practice), distribution of study drug, evaluation of data management and statistical analyses in addition to how to evaluate the results.
You will be able to write a study protocol and be able to initiate as phase IV clinical trial. You will in addition get an overview of how to apply for all necessary approvals needed to start a clinical trial. You will also get an overview of different types of study designs which will make you able to evaluate if a published clinical trial is of good enough quality.
The ethical base of the study is in line with the Helsinki declaration and other international guidelines.
Admission to the course
PhD candidates from the University of Oslo should apply for classes and register for examinations through?Studentweb.
If a course has limited intake capacity, priority will be given to PhD candidates who follow an individual education plan where this particular course is included. Some national researchers’ schools may have specific rules for ranking applicants for courses with limited intake capacity.
PhD candidates who have been admitted to another higher education institution must?apply for a position as a visiting student?within a given deadline.
Formal prerequisite knowledge
A 5 year master degree in pharmacy or relevant topic.
Overlapping courses
- 10 credits overlap with FRM5730 – Clinical Drug Trials (discontinued).
Teaching
Lectures, group discussions, and mandatory projects in groups. The main focus of the teaching strategy will be on lectures and group projects and will include study design and planning of clinical trials. The students have to write a clinical protocol in groups of 3-4 students, and reflect on which approvals that is needed in order to start a clinical trial.
Every student must also give an oral presentation for the other students based on one or several review articles.
Examination
A four hour written exam/oral exam after the number of students.
The mandatory group project is 1/3 of the total grade, but will not be evaluated separatly.
Language of examination
You may submit your response in Norwegian, Swedish, Danish or English. If you would prefer to have the exam text in English, you may apply to the course administrators.
Grading scale
Grades are awarded on a pass/fail scale. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more:
More about examinations at UiO
- Use of sources and citations
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.