Industry-Sponsored Research Week

U Wisconsin-Madison moves to cut red tape in industry-sponsored clinical trials

By David Schwartz
Published: October 14th, 2019

Responding to pleas from Top of Formentrepreneurs, investors, and other stakeholders over what they viewed as an overly bureaucratic and slow clinical trial process, the University of Wisconsin-Madison has taken action to cut out red tape and make clinical trials more industry-friendly.

Critics several years ago cited UW-Madison’s overly complex and maddening barriers that made it difficult for companies to advance potentially life-saving healthcare ideas from the lab bench to the marketplace.

Those complaints were taken seriously by the school, culminating in a hard-hitting 2018 report written by Mary Westrich, one of the nation’s leading experts on clinical trials. UW-Madison, the report stated, “has evolved to interpreting regulations, requirements, policies and standards in the narrowest sense; commonly gravitating to the most conservative interpretation possible to protect the institution from any risk or liability through tight bureaucratic control…. The result stifles potentially beneficial — even life-saving — research to patients with no counterbalanced benefit of increased patient protection.”

Westrich based her finding on interviews with 140 individuals who have been involved in the clinical trials process. “The culture of the Institution does not encourage the conduct of industry-sponsored trials, nor make them easy to conduct,” she concluded.

Led by UW Health’s CEO Alan Kaplan and Robert Golden, dean of the School of Medicine and Public Health, an internal assessment has now produced a set of fixes that the university believes will get more research translated to the clinic in less time.

The assessment calls for UW-Madison change its administrative structure and its culture. That effort began with the hiring of a chief clinical research officer who brings decades of clinical trial experience to the job. Betsy Nugent, who spent 13 years building the clinical research network for Kaiser Permanente centers in the Rocky Mountain region, became the first campus clinical trials “czar” in September.

Nugent helped Kaiser to reduce the amount of time needed to organize a clinical trial from nearly a year to less than two months. Patient safety and efficacy standards improved by establishing streamlined entry points and consolidating functions. The system became a national model for clinical trials management.

“I won’t say it was easy,” Nugent said, but the result at Kaiser was a more predictable process around expensive trials that can bankrupt a young company if there are unnecessary delays.

The school is hoping for similar results. “UW Health should really be a leader,” said Thomas “Rock” Mackie, a researcher and serial entrepreneur who recently became UW Health’s chief innovation officer. “This is a unique opportunity in academics.… The rewards are not just financial, but reputational in terms of advancing human health.”

Nugent, Mackie and Kurt Zimmerman, who will direct the Office of Industry Engagement within the medical school, will lead what’s called the “Isthmus Project.” It draws its name from the concept of better connecting research, trials and patient care. That will include working more closely with other medical institutions in Wisconsin and beyond.


Posted under: University-Industry Engagement Week

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