| Bruce D Schatzman at Advanced Clinical Software Inc, recognises that, when it comes to EDC solutions there is a plethora of choice, especially considering the increasing growth and accessibility of CTMS
Having spent the last decade rolling out EDC solutions, many have described the industry as jaded. Although there were doubters at the beginning, EDC has delivered on its promise of a much improved clinical data collection process – it just took 10 years longer than most people expected! In any case, EDC is maturing nicely.
So why would we want to give those dedicated but exhausted professionals new mountains to climb? There is plenty of additional work to do, especially in the areas of integrating EDC systems with clinical data management systems, building or improving data warehouses, implementing CDISC instead of just talking about it, and other bioinformatics projects that present IT professionals with new challenges.
Although these projects are worthwhile, a growing community within the biopharmaceutical industry understand that EDC only makes the process of clinical data collection and analysis more efficient – it has little or no impact on cost reduction in other areas of the clinical development process. Unfortunately, there seems to be a lingering perception that EDC is the panacea to the problem of clinical trial inefficiency. There’s no mathematical formula for measuring what percentage of a ‘total possible efficiency’ EDC represents, but when we think about some of the other production components of a typical clinical trial, it’s clear that EDC is just one slice of a much larger pie.
A clinical trial can be divided into two areas: clinical and operational. EDC, clinical data management (CDM), biostatistics, clinical data warehousing and related topics cover most of the clinical side. That’s where the majority of the time, money and energy has been dedicated – not just for efficiency reasons, but because data accuracy, subject safety, and longitudinal analysis are also addressed. |
