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Innovation Fund supports new clinical trial protocol generation system

Thirteen-year-old Gilberto is suffering from refractory neuroblastoma, a tumor of the sympathetic nervous system that has dissipated throughout his body. Recently, he hit a roadblock in his treatment that is all too common at hospitals and clinics around the country.

His doctor wanted to enroll Gilberto in a clinical trial. Alas, the trial was not yet open at the hospital where Gilberto was being treated because all of the necessary paperwork had not yet been processed.

“This kind of thing happens everywhere because of the way clinical protocols are generated and implemented,” says Samuel Volchenboum, assistant professor of pediatrics at the University of Chicago.

An informatics expert as well as an oncologist, Volchenboum is out to streamline the entire way clinical trials are organized, managed, tracked and reported. To help make that possible, the Innovation Fund, the University of Chicago’s venture philanthropic proof-of-concept fund, awarded Volchenboum $40,000 in its fourth round of funding this June.

“Dr. Volchenboum brings a unique perspective and a deep understanding of diverse domains to the clinical trial process,” says Eric Ginsburg, an assistant director at UChicagoTech, which administers the Innovation Fund. “As a practicing oncologist, he treats patients in clinical trials, is a principal investigator on several trials, and is part of a comprehensive nationwide network of practitioners in the field. And as a research bioinformatician, he has demonstrated his ability to develop software to aid researchers and clinicians.”

Volchenboum is assuming leadership roles in the University’s bioinformatics infrastructure, serving as associate chief of the Center for Research Informatics and co-director of the Biomedical Informatics Core of the Clinical & Translational Science Awards. Subsequent to the Innovation Fund award, he was appointed associate director of the Institute for Translational Medicine.

Ginsburg and Nancy Harvey, Executive-in-Residence at UChicagoTech, have been helping Volchenboum refine his plans and extend his network of advisors. Volchenboum says, “The funding and guidance from UChicagoTech have been essential to developing this idea into a mature and viable proposal. Eric and Nancy continue to provide valuable advice and important assistance in navigating the complex avenues necessary to achieve our goals.”

In particular, the Innovation Fund grant is enabling Volchenboum to explore complementary efforts in academia and pharma, as well as reach out to prospective users both within the University of Chicago and beyond.

Taking into account the findings from these explorations, a medium-term goal is to build the prototype proof-of-concept of an extensible web-based system that will generate clinical trial protocols, streamline the process of opening studies at treating centers, integrate them with electronic medical records, issue work orders, and automatically create the reports required by hospitals, pharmaceutical companies and the Food and Drug Administration.

Improving clinical trials

Currently, most clinical trials in the U.S. are governed by disparate paper-based systems and archaic, inefficient workflows. As a result, burdensome paperwork, lengthy approval processes, outdated manual transcription methods, missed tests, inconsistent interpretations and time-consuming reporting requirements can lead to wasted money and delayed drug approvals, Volchenboum says. “Pharmaceutical companies involved in clinical trials are being held hostage by antiquated paper forms and delayed, incomplete and often erroneous reporting, while caregivers rely on laborious, error-prone systems for care delivery.”

Many initiatives over the last decade have sought to make clinical trials more efficient by introducing automation at selected steps in the process. None, however, have taken a holistic approach—until now. “Our product will automate the entire protocol process from start to finish,” Volchenboum says. “That could make us the first-to-market with this type of solution.

“Furthermore, the increased widespread adoption of electronic medical records throughout all healthcare settings makes our vision of improving the efficiency, accuracy and reliability of protocol design and use extremely doable,” he adds.

Since the system will be extensible, it would not be restricted to oncology. In fact, it could be used in a wide range of clinical trials across adult and pediatric medicine for medical devices, as well as pharmaceutical agents.

“This project represents a unique approach to a ubiquitous problem,” Ginsburg says. “With the Innovation Fund grant and further support, we expect this work to lead to a comprehensive, fully automated system for clinical trial protocol generation and management.”

Greg Borzo

Photos

An informatics expert as well as an oncologist, Samuel Volchenboum, MD, PhD, plans to streamline the entire way clinical trials are organized, managed, tracked and reported.

An informatics expert as well as an oncologist, Samuel Volchenboum, MD, PhD, aims to streamline the way clinical trials are organized, managed, tracked and reported. The Innovation Fund, the University of Chicago’s venture philanthropic proof-of-concept fund, awarded Volchenboum $40,000 to develop his idea.

Photo by Robert Kozloff

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