Thursday, July 19, 2012

Measuring Quality: Probably Not Easy


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.

1 comment:

mrcmeyer said...

I think you need to take a broader perspective on "quality". It should relate to any procedures and data that are critical to the reliability of the study findings.

The recent FDA Guidance for Industry
"Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring" provide a nice overview of which data you should focus on from a quality perspective.

Solely looking at query rates is a simplification.