Thursday, October 11, 2012

TransCelerate and CDISC: The Relationship Explained

Updating my post from last month about the launch announcement for TransCelerate BioPharma, a nonprofit entity funded by 10 large pharmaceutical companies to “bring new medicines to patients faster”: one of the areas I had some concern about was in the new company's move into the “development of clinical data standards”.

How about we transcelerate
this website a bit?
Some much-needed clarification has come by way of Wayne Kubick, the CTO of CDISC. In an article in Applied Clinical Trials, he lays out the relationship in a bit more detail:
TransCelerate has been working closely with CDISC for several months to see how they can help us move more quickly in the development of therapeutic area data standards.  Specifically, they are working to provide CDISC with knowledgeable staff to help us plan for and develop data standards for more than 55 therapeutic areas over the next five years.
And then again:
But the important thing to realize is that TransCelerate intends to help CDISC achieve its mission to develop therapeutic area data standards more rapidly by giving us greater access to skilled volunteers to contribute to standards development projects.   
So we have clarification on at least one point: TransCelerate will donate some level of additional skilled manpower to CDISC-led initiatives.

That’s a good thing, I assume. Kubick doesn't mention it, but I would venture to guess that “more skilled volunteers” is at or near the top of CDISC's wish list.

But it raises the question: why TransCelerate? Couldn't the 10 member companies have contributed this employee time already? Did we really need a new entity to organize a group of fresh volunteers? And if we did somehow need a coordinating entity to make this happen, why not use an existing group – one with, say, a broader level of support across the industry, such as PhRMA?

The promise of a group like TransCelerate is intriguing. The executional challenges, however, are enormous: I think it will be under constant pressure to move away from meaningful but very difficult work towards supporting more symbolic and easy victories.

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