Clinical Trials Epidemiology (1.5 hp), 1.5 hp

Beskrivning

This course will give an introduction to the concepts and methods of randomized clinical trials. It will be given over a 1-week period at half pace, held in-person at Uppsala University (13.00-16.00, Monday 3rd – Friday 7th October), in combination with 10 x 1 hour digital learning sessions, which will be held online each week following the in-person teaching (Tuesdays 15.00-16.00). The total course duration will correspond to 5 full days (1.5 credits). A final schedule will be distributed in the weeks before the course.

To the extent possible, the course will utilize students’ own ongoing or planned clinical trials as examples and exercises. Please provide a brief project description in your application. The course requires knowledge of basic epidemiological and statistical concepts, as detailed below.

Innehåll

The course covers three parts: a basic introduction and an overview of the basic concepts of clinical trials, (including quantitative and statistical issues), and a more in-depth coverage of selected topics relating to trials.

Basic Introduction:
• Observational Study of interventions
• Randomized clinical trial overview
Quantitative and Statistical Concepts of Clinical Trials:
• Trial Design: Questions, Subjects, Treatments, Endpoints
• Trial Design: Types of Trials
• Trial Conduct: Randomization
• Trial Analysis: Analysis Groups, Intention to Treat
• Trial Analysis: Adjustments, Subgroups
• Pilot Studies
• Protocol Development
Selected Clinical Trial Topics
• Trial Monitoring and Stopping rules
• Adaptive randomization
• Equivalence and Non-inferiority trials
• Group randomized trials
• Generalizability of trials

Undervisning

The course is aimed at PhD students who have an interest in randomized clinical trials. Students involved in their own ongoing or planned clinical trials are particularly urged to take part. The students should be familiar with basic epidemiological concepts (including study designs, bias, confounding, measures of outcomes, absolute and relative measures of association) and statistical concepts (including linear and logistic regression, purpose of covariate adjustment, basic knowledge of survival analysis). Applicants from Uppsala University will be given priority.

Your application should be written in English and should include a brief project description and an summary of any courses or equivalent experience you have in epidemiological and statistical methods.

Examination

The course will be held in-person at Uppsala University 13.00-16.00, Monday 3rd – Friday 7th October, and 10 x 1 hour digital learning sessions, Tuesdays 15.00-16.00 held online each week following the in-person teaching (meeting link to be circulated later). Attendance both in-person and online is mandatory and active participation is required to pass the course.

Litteratur

Dr. Baron will circulate a clinical trials monograph shortly before the course begins, as well as a list of recommended texts and articles.

Lärare

John A. Baron, MD, MS, MSc, Professor Emeritus of Medicine and of Epidemiology at the University of North Carolina, and Professor Emeritus of Medicine and of Epidemiology at the Geisel School of Medicine at Dartmouth, and Guest Professor at the Department of Surgical Sciences, Orthopedics, Uppsala University. He has great experience in both large-scale clinical trials and advanced epidemiology.

Kontakt

For questions regarding the course, please contact Hannah L Brooke, Department of Surgical Sciences, Uppsala University (hannah.brooke @ surgsci.uu.se).

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