Lisa Henderson
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This month, Applied Clinical Trials highlights the Academic Medical Center and its role in clinical trials. We have provided this special issue, focusing on
different aspects of this segment, to provide insight into the AMC as it too turns toward a new decade, and new changes in
drug development. These areas include: the investigative site, technology adoption, other models, increased CRO/AMC collaboration,
and investigator training. Taken separately, these issues are inherent to every stakeholder in the clinical trial chain. However,
in addition to being complex, academia can be a bit confounding to many on the "outside" in regard to understanding its placement
in these areas.
Let's go with what we—admittedly on the outside—do know.
It was reported in 2006 that share of industry-sponsored clinical trials to academic institutions dropped steadily from 80%
in 1991 to 60% in 1994 to 26% in 2006 (Thomson CenterWatch, at that time).
Government finances much of the academic medical research, and in 2004 it was reported that 75% of those dollars went to 40%
of the nation's 125 medical schools. And, much of that went to basic medical research, not necessarily to drug trials (New York Times). However, NIH funding has fallen flat to down of late. We know that there was a shift in the late 90s among academic institutions, whereby some became more involved in clinical
trials and others did not. Those who went the first route either centralized clinical trials offices for services to investigators,
and/or established their own CROs.
We know that finding a contact for an AMC's industry-sponsored clinical trial on its University-based Web site is difficult,
which from a business standpoint, we don't get.
We also know that those in academia care very much about what they do and devote much of their brain power toward improvement.
Examples include the Clinical Trials Transformation Initiative (CTTI) at http://trialstransformation.org/ and Eliminating Disparities in Clinical Trials (EDICT) out of Baylor at http://www.bcm.edu/edict/.
Let's touch briefly on what we do not know, the exact reasons why AMCs lost industry dollars. There are numerous speculations
and popular interpretation puts blame squarely on CROs. However, Josef von Rickenbach, chairman and CEO of Parexel (and no
stranger to CRO history) disagrees:
"AMCs never had the capacity to perform large scale global trials, as global CROs do. Biopharmaceutical companies have increasingly
outsourced work that used to be done in-house to CROs, which are bound by GCP guidelines required by the regulatory authorities,
and in the process, the productivity and efficiency of the clinical trial process has been significantly enhanced."
However, it remains an area of debate. Marcia Angell, MD, former editor of the New England Journal of Medicine, maintains that the close ties of CROs and pharma is not good for clinical trials and that academia should get the control
of the trials back. Whatever your view, our report represents the state of the AMC today.
Lisa Henderson Editor-in-Chief email: lhenderson@advanstar.com
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http://www.appliedclinicaltrialsonline.com/
