Av Ju

4 Questions 3 Answers 0 Followers

Questions related from Av Ju

How to treat subjects moving from one treatment group to the other?

Hello all, In a clinical trial, a subject is assigned to the new intervention group. The device is a topical cream. During the application, something goes wrong, and the doctor decides to stop...

20 March 2017 4,230 5 View

How to handle missing values in one arm studies?

Hello all. I have a small question. Assume a one arm clinical trial, with the primary endpoint being safety related: 1 = A subject had AE (at least one), 0 = the subject did not have any AE. In...

01 January 2016 1,684 3 View

Does anyone know of common scales for measuring 'quality of healing' in wound care?

Hello all. In the FDA guideline regarding wound healing (like diabetes foot ulcers) it is defined that the "quality of healing" will consist of two components: cosmetics and function, where...

08 September 2015 4,790 8 View

How would you design a first clinical trial with a relatively rare event ?

A new device intends to prevent a bad event. With the current treatment the events occurs at 10% of patients undergoing the medical routine. The new device claims to be not worse than the current...

04 April 2015 1,831 1 View