Fundamentals of Randomized Controlled Clinical Trials

General information:

Date 23 – 25 September 2019
9:15 – 16:30
Location ISPM, Mittelstrasse 43, 3012 Bern, room 216
Course flyer Course_Flyer_Clinical Trials_Trelle_09_2019
Teacher PD Dr. Sven Trelle (CTU Bern)
Prof. Marcel Zwahlen (ISPM)
Timetable Timetable_Clinical Trials_2019

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 20 September by using this form: Survey_Topics to be 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 Intravenous Thrombolytic trial_Gissi_1986. 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
Template Key Components Studies

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_Other Forms Of Trials
Lecture_How large should the trial be
Lecture_The Study Protocol – Common Pitfalls
Lecture_Case Studies