I am a bit delayed getting my latest post up. I am writing up some thoughts on this recentstudy put out by ARCO, which suggests that the level of quality in clinical
trials does not vary significantly across global regions.
The study has gotten some attention through ARCO’s press release (an interesting range of reactions: the PharmaTimes headline declares “Developingcountries up to scratch on trial data quality”, while Pharmalot’s headline, “WhatProblem With Emerging Markets Trial Data?”, betrays perhaps a touch more
skepticism).
And it’s a very worthwhile topic: much of the difficultly,
unfortunately, revolves around agreeing on what we consider adequate metrics
for data quality. The study only really
looks at one metric (query rates), but does an admirably job of trying to view
that metric in a number of different ways.
(I wrote about another metric – protocol deviations – in a previous
post on the relation of quality to site enrollment performance.)
I have run into some issues parsing the study results,
however, and have a question in to the lead author. I’ll withhold further comment until I head
back and have had a chance to digest a bit more.
