Fundamentals of Randomized Controlled Clinical Trials

General information:

Date 21 – 23 September 2020
9:15 – 16:30
Location ISPM, Mittelstrasse 43, 3012 Bern, room 216
How to reach Mittelstrasse 43
Course flyer Course_Flyer_Clinical Trials_Trelle_Zwahlen_09_2020
Teacher PD Dr. Sven Trelle (CTU Bern)
Prof. Marcel Zwahlen (ISPM)
Timetable Timetable

Preparatory work:

1) Small Survey:
We have reserved a bit of time for trying to cover individual topics on day 3. Please send your “wishes” back to us by 18 September by using this form: Survey_Topics_To_Covered

2) Pre-readings:
Please read these two articles prior to the course: Declaration of Helsiniki_JAMA2013 and History of RCTS_Bothwell 2016 NEJM
Please have a look at these two trials:  Pertussis prophylaxis trial_Bell_1941 and GISSI_1986_Lancet_1_397. They will be discussed on the first course day.

Course material:

Day 1:
Akacha_Estimands in clinical trials_2017
Atkin_Sigmoidoscopy screening in prevention of colorectal cancer_2010
Dodd_Adjustment for treatment changes in epilepsy trials_2017
Dodd_Framework for the design, conduct and interpretation of RCTs_2017
Hernan_Beyond the intention-to-treat_2012
Hollis_What is meant by intention to treat analysis_1999
Le Tourneau_Molecularly targeted therapy_2015
Mansournia_Biases in Randomized Trials_2017
Lecture_Good Clinical Practice
Lecture_Key Aspects of RCTs
Lecture_Why RCTs

Day 2:
Bartlett_Extracorporeal circulation in Neonatal Respiratory Failure_1985
Combes_Extracorporeal Membrane Oxygenation_2018
Lecture_Outcomes Adjudication

Day 3:
Bacchetti_Current sample size conventions_2010
Rothman_Planning Study Size_2018
Lecture_How large should the trial be
Lecture_The Study Protocol – Common Pitfalls

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