Cancer specialist Dr. Richard Schilsky, Professor in Medicine, has been named Associate Dean for Clinical Research in the Division of the Biological Sciences.

Schilsky named Associate Dean

Cancer specialist Dr. Richard Schilsky, Professor in Medicine, has been named the Associate Dean for Clinical Research in the Division of the Biological Sciences, effective July 1.

This new position was created to strengthen existing clinical research, develop novel programs within the division, and better position the Hospitals to remain a leader in clinical testing of promising new medications.

“The discovery and dissemination of new knowledge is our core academic mission,” said Schilsky, “and clinical research, the application of basic science discoveries to improve treatment outcomes and devise better detection and prevention strategies, is a crucial component of that mission.”

Schilsky’s mandate is to consolidate and enhance the clinical research infrastructure throughout the division. That includes setting up training programs for faculty and staff on the methods and requirements of research involving human subjects; adding new quality improvement programs to ensure the scientific validity of all clinical research data; and making certain that every aspect of all clinical research is in compliance with current and anticipated regulations––an issue that has recently come to the fore following federal sanctions against several academic medical centers.

“Our goal is to have reliable, tested systems in place that will enable our scientists to bring their own innovative ideas into the clinical arena safely, quickly and efficiently, but that also will make our institution an attractive place for drug or medical equipment companies with exciting new agents and devices,” said Schilsky. “There’s more competition for sponsored research than ever before, but there is much more opportunity to take part in truly innovative clinical studies.”

Schilsky’s first steps include appointing a faculty advisory committee on clinical research and setting up a clinical trials office to provide oversight and serve as a single point of contact for inquiries from the pharmaceutical industry. That office will establish a clinical research curriculum committee, which will organize formal training programs for all investigators and their staffs, as well as seminar series on aspects of clinical research. In collaboration with Ron Thisted, Chairman of Health Studies, a biostatistics advisory group will be formed to help investigators plan efficient, informative trials and collect and analyze their data.

The next steps will involve centralizing data management and setting up systems to coordinate patient recruitment, registration and follow-up––not just for trials at the University Hospitals, but for multicentered, national trials as well.

“None of this is simple,” noted Schilsky, citing the example of billing. Patients choose University Hospitals because they have multiple, complex medical problems.

“Maybe we can treat some problems with standard therapies, but for other problems, the best solution might involve a clinical trial,” explained Schilsky.

“Trying to separate the expenses that should then be covered as research from clinical expenses requires care and diligence, but it’s absolutely crucial to get it right.”

Schilsky brings considerable research and clinical experience to the post. As Director of the University Cancer Research Center for eight years, he managed the growth of one of the medical center’s leading and best-organized clinical research teams. He also has served for three years as a member, and will continue to serve as chairman, of the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee, which recommends action on all new anticancer agents. Schilsky also was recently appointed to the National Cancer Institute’s Board of Scientific Advisors and will continue to serve as chairman of the Cancer and Leukemia Group B, a national clinical research organization headquartered at the University.