ARVO Foundation: Design, conduct and management of clinical trials in eye research

 
Sponsored by
ARVO
 
Lunch is included in the course fee.
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Testing new strategies for the treatment or prevention of eye diseases will ultimately require clinical trials, the basic methodology that supports evidence-based medicine. While grounding in appropriate clinical trials methodology can require years of training and /or experience, short courses to introduce key topics and provide links to more detailed material are critical to imparting the basics elements needed to conceptualize a well designed and run clinical trial. While short courses on basic clinical trial methods and issues are available, clinical trials in eye disease present unique challenges, due to the presence of two eyes. This course on clinical trials specifically for vision researchers will greatly enhance the understanding of current issues, state of the art approaches to problems in clinical trials and how to conduct a trial in ophthalmology.

Expert faculty will present key elements in the design, construct and execution of a clinical trial. Topics include randomization, criteria for eligibility and impact on generalizations, and role of standardization and special facets of multi-center trials. Faculty will include biostatisticians, and clinicians experienced in the design and implementation of clinical trials in eye disease.

Participants need to register to the EVER congress and register for the course.
Lunch is included in the course fee.
 
 
Session type
Course
 
Time and place of session
This session will take place on Tuesday 30 September 2008 from 08:00 till 16:30 in room Adria.
 
Abstracts assigned to this session (6)
08:00 15'   Check-in
08:15 45' 2161 Principles of clinical trials WORMALD R
09:00 45' 2162 Design of clinical trials: Introduction to study design and levels of evidence in medicine ROSSETTI L
09:45 15'   Break
10:00 45' 2163 European Union Clinical Trials Directives DANIELSON L
10:45 45' 2164 Operational Aspects: Practical aspects of conducting a trial RIBEIRO L
11:30 60' 2165 Interim monitoring and analysis: Statistics in clinical trials MUSCH D
12:30 45'   Lunch
13:15 105'   Practicum: Design a trial
15:00 60'   Presentation of designs and discussions
16:00 30' 2166 Summary: Ethical issues in trials WORMALD R