Wednesday, September 14, 2011

High standards in evidence at Duke

Here's the counter-example to the folks at Parkland Memorial Hospital, in terms of transparency and taking ownership for failure.  After bouncing around the scientific world, the story regarding a Duke University School of Medicine researcher padding his resume went worldwide last year, but there were also questions raised about the methodology behind the three clinical trials.  This kind of thing is an embarrassment to any institution, and the manner in which it is handled is indicative of the kind of leadership in place.

Hunt Willard, the Director of the Institute for Genome Sciences & Policy, has issued a letter to the community that makes clear he is the exemplar of what you would hope for.  Here are the key excerpts:

These events represent a teachable moment for all of us, and I want you to hear directly from me about what I think it means for us.

It is very clear now that we were too slow to recognize and acknowledge flaws in the underlying data, insufficiently attentive to the need to carefully track versions of both data and software, and inadequately responsive to external publications and communications that pointed out errors in the underlying data. All of these indicate a need for a tighter process, and I recognize all of this as a failure of leadership and a failure of oversight, failures for which, as director of the IGSP, I feel a level of responsibility.

In accepting responsibility for these failures, I underscore my deep commitment to the responsible conduct of research and to setting standards for accountability at all levels of our organization. I welcome your thoughts in this area, as well as any concerns you may have throughout the coming year.

Really, what more could you ever want from a leader?  But there is more, a lesson in the nature and values of the profession:

Bravo to Dr. Willard and his colleagues.


Anonymous said...

The scientific review process is imperfect due to imbedded incentives and misalignment of professional promotion (e.g. quantity over quality) to intellectual rigor. While slow to change given increasing intensity of competition for resources, business-as-usual clinical trials are increasingly challenged on scientific, methodological and ethical grounds.

Had this not been a clinical trial, but a poorly conducted or documented medical procedure, or poorly reported measure on a quality spreadsheet, would it have been caught? If IRB, funding source, and professional peers did not adequately scrutinize the scientific merit of clinical research methodology, what hope is there for adequate oversight of actual clinical practice methodology?

Who are the independent, sufficiently expert reviewers of medical practice? It obviously isn't CMS or Joint Commission. In years of quality improvement attention, I have never seen the issue of expert oversight of hospital quality remotely addressed. (And a preventable patient death is more likely than a poorly run clinical trial).

Halie (Scrubs Editor) said...

I hadn't heard of this story. Thanks for bringing it to light!

Amy said...

Interesting read. As mentioned above there are other issues that if handled with different leadership could lead to problems. Quality leadership took ownership of the problem. That's a great point to see emphasized