This study aimed to illustrate how sponsors should measure quality of clinical trials and identify the various drivers of performance. It was able to actually quantify the magnitude of the relationship between each of the drivers of performance and quality of conduct as well as measure quality directly. Routine trial management measures like ‘number of days to recruit’ and ‘number of data queries’ are simply measures of ‘time’ and ‘defect’, the authors point out, rather than a measure of quality itself – although they must surely be related to quality as performance drivers.
It is important to realise the implications of apparently ‘insignificant’ drivers of quality that were identified (e.g. the negative coefficients for ‘adherence’ and ‘monitoring’) since this is a bit misleading as the authors point out; for it means only that changing the level of the driver does not change quality and not that it is unimportant element of quality in a trial – they called such elements ‘hygiene drivers’ of quality that do not work to increase quality, but will ‘degrade’ quality if they are not present. In this respect, they discuss implications for risk-based monitoring (‘RBM’ – don’t we hear a lot about these days? No post on trials should be without a mention…). They say that using standard operational metrics to guide RBM could lead to a backward view of the trial and ‘gaming’ by the sites. With the obviously positive correlation between maintenance of good site relations and quality, there is complex relationship between attempts to maintain data integrity and quality of trial conduct.
All in all, the authors of this study maintain that the online (cloud-based) clinical trial questionnaire system they have developed is a statistically validated trial assessment platform that uses appropriate scientific measurements and can provide insights and data on quality that are not available from regular clinical trial management systems, which tend to be based on simple operational metrics.
Don’t fall into the ‘metrics trap’ they say. We should look beyond simple metrics to improve the quality of clinical trials and this seems to be sensible advice – despite the fact that it is from people who have a vested interest in a means of doing this…..
- http://www.fda.gov/downloads/Drugs/…/Guidances/UCM269919.pdf (accessed 20/11/2015)
- Lawrence X. Yu, Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharmaceutical Research, April 2008, Volume 25, Issue 4, pp 781-791
- Howley, MJ and Malamis, P. Quality drivers in clinical trial conduct available at: http://read.findpharma.com/i/569396-applied-clinical-trials-ebook-2015 (accessed 25/11/2015)