We are now meeting under the auspices of a new School of Medicine Committee on Clinical Research, chaired by Dean Andrews and including myself, Scott Gibson (Exec Vice Dean for Admin,), Mark Stacy (Vice Dean for Clinical Research), Jeff Ferranti (CMIO for Duke Medicine), the DCRI Director and Sally Kornbluth (Vice Dean for Basic Science). Becky Moen MBA has taken on the job of administration for the TMQF effort and the implementation  is really taking shape with her involvement.
We are struggling with a number of difficult issues where the right balance is not entirely clear, including:
1. How do we define accountability of the quality of translational research?
2. Â In the basic science labs, is documentation of data provenance (“reproducible research”) a requirement or is it optional?
3. In human research, how far do we go in mandating reproducible data systems and significant input/collaboration/oversight by biostatistics?
4. How do we structure a system to oversee management of conflict of interest in translational research (we’re confident that we have a system for identifying COI and designing plans for management; its the execution that needs work)?
There is an interesting set of issues around the economy of site based research that will be the topic of serious discussion involving the SBR directors.
I hope that people will join in a vigorous debate about the topics so that we can go forward with a plan that has the support of the faculty and staff because the development of the plan has been inclusive.
Interest in this issue will be heightened when the case of Anil Potti airs on 60 Minutes, which I’m told likely to happen on Feb 12th, although decisions on airing are held tightly by CBS for obvious reasons.
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On 3, in how far do we go, it seems that some are thinking beyond translational medicine to all clinical research. That would be impossible without a vast increase in our biostatistics faculty and staff. It is going to be hard enough to just cover bench-to-bedside.