Construction of trial protocols for controlled clinical trials
This course is aimed to those of you who plan to conduct clinical research projects. Designing a good project plan is of crucial importance for creating a project with credible results. The course will review key concepts for scientific experiments, focusing on practical and theoretical design of controlled clinical trials.
The first part will cover the design of the experimental protocol, measurements hypotheses, population and selection, representative sampling, stratification and randomization procedures and study design. A significant part of the course consists of discussions of the various methods used in the planning of clinical trials, and how these methods are related to statistical models.
Central themes of the course will be factors and variables, establishment of database, choice of statistical models and calculation of sample size.
The course covers one week of studies (1.5 ECTS), including lectures, discussions, assignments and student presentations. Attendance is compulsory. An attendance record of at least 75% is required to pass this course and no video link is provided since discussions and other team efforts are important parts of the curriculum.
Syllabus and other information
Syllabus
PVG0039 Construction of trial protocols for controlled clinical trials, 1.5 Credits
Subjects
Veterinary MedicineEducation cycle
Postgraduate levelGrading scale
Prior knowledge
Admitted to a postgraduate program in animal science, biology, veterinary medicine, food science, nutrition, nursing, bioinformatics or similar subjects, or to a residency program in veterinary science.Objectives
The overall objective of the course is to train students to plan clinical research projects with appropriate methods, and to make the students aware of how different trial protocols relate to different statistical models. After completing the course the student should be able to:
-Formulate aim and hypothesis
-Describe the concepts population, selection and sampling, and to perform sampling correctly
-Perform stratification and randomization
-Handle drop-out and patient withdrawals, and to handle a discontinuation process
-Choose a correct study design and to collect high quality data
-Describe how the study model corresponds to statistical models
-Assess and present results
Content
This course is aimed to those of you who plan to conduct clinical research projects. Designing a good project plan is of crucial importance for creating a project with credible results. The course will review key concepts for scientific experiments, focusing on practical and theoretical design of controlled clinical trials.
The first part will cover the design of the experimental protocol, measurements hypotheses, population and selection, representative sampling, stratification and randomization procedures and study design. A significant part of the course consists of discussions of the various methods used in the planning of clinical trials, and how these methods are related to statistical models.
Central themes of the course will be factors and variables, establishment of database, choice of statistical models and calculation of sample size.
The course covers one week of studies (1.5 ECTS), including lectures, discussions, assignments and student presentations. Attendance is compulsory. An attendance record of at least 75% is required to pass this course and no video link is provided since discussions and other team efforts are important parts of the curriculum.
Formats and requirements for examination
Development of a research protocol within own program.
Additional information
The course will take place in SLU’s Centre for Veterinary Medicine and Animal Science on campus Ultuna in Uppsala. The course is given in collaboration with the network CAReNet, www.slu.se/carenet.For application: https://www.slu.se/gs-vmas-courses
Responsible department
Department of Clinical Sciences