CRR of the IOM

Perhaps you missed it too! I came across a fascinating report in a back issue of JAMA from a subset of members of the Clinical Research Roundtable (CRR) of the Institute of Medicine. Apparently, these well-intentioned leaders have been meeting for three years to assess the state of the clinical research infrastructure in our country. They defined the clinical research process as the act of translating basic research for the health of the public (Crowley 2004).

DAVID B. NASH, MD, MBA

I was not surprised to see the CRR characterize the clinical research effort in United States as “a fragmented cottage industry constituted of multiple stakeholders… with no overarching vision, no cohesive organizational framework, and at times not even a common forum for dialogue or active collaboration. The current poorly articulated and highly compartmentalized components of the existing nonsystem are inefficient and often redundant.”

To this, I am sure most of our readers would add, “A-men!”

ROADBLOCKS TO PROGRESS

The CRR conceptualized the challenges facing the clinical research enterprise of the nation as two translational roadblocks. Picture two foci of constriction along an otherwise freely flowing pipeline. The first constriction is the traditional “bench-to-bedside” transfer of basic discoveries into human testing. The CRR believes that this roadblock has been reasonably well removed by the work of the National Institutes of Health and the near doubling of the NIH budget in the last decade. The second constriction is the difficulty “implementing therapeutic advances proven effective in large, well-conducted clinical trials into the daily practice of medicine.” Those of us who have worked in the health services research field have a visceral understanding of this.

Because of these two critical roadblocks and our “nonsystem” of clinical research, the CRR calls for the creation of a public-private partnership — the National Clinical Research Enterprise, or NCRE. Such an organization — which is funded by a 0.25 percent tax on the key healthcare stakeholders — would have, in CRR’s words, “dual accountability to the public and its constituent member organizations.” NCRE’s main agenda would be to oversee and integrate the nation’s diffuse and inefficient investments in clinical research and to channel adequate funding into peer-reviewed projects to implement the changes that are necessary for a safer, more efficient, and self-sustaining enterprise.

MONEY MAKES IT HAPPEN

No informed individual could argue with the CRR’s description of our system. My view is that, regrettably, creation of an NCRE will not solve the problems we face. That second translational roadblock is a doozy!

The real issue, in my view, is the creation of appropriate economic incentives coupled with robust public reporting of outcomes that would heavily influence clinicians at all levels to more rapidly adopt proven scientific advances into their everyday practice. We have nearly two decades of evidence that the diffusion of evidence-based practice is hampered by the lack of appropriate financial and other incentives. We know what we need to do, but there is not a compelling reason to improve what we actually do!

I am intrigued by the work and the skillful analysis of the CRR. Our readers should be abreast of these issues and participate in the conversation. Even the CRR noted that “There is not a common forum for dialogue or active collaboration.” Perhaps Biotechnology Healthcare can be a reasoned voice in this cacophony. I am interested in your views.

You can reach me at me via e-mail at david.nash@jefferson.edu.