Sept. 16, 2019:

Every year, selected junior investigators learn how to design effective clinical trials for therapeutic interventions in treating cancer during an intensive week-long workshop hosted jointly by the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR). The conference, known in oncology circles as the “Vail Workshop,” is held in Vail, Colo. and is an ideal backdrop for clinical and research oncologists to unplug, network, and gain valuable feedback from leading investigators in oncology in a retreat-like setting.

“For junior investigators, the ASCO/AACR Methods in Clinical Cancer Research Workshop offers invaluable educational and professional development experience,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FSCT, FASCO. “By attending, these young scientists and researchers will get to spend an intensive week working with leaders in the clinical oncology field, collaborating with specialists in biostatistics, imaging, pharmacology, and pathology to help support their project development. They also will get input from and access to patient advocates for the patient perspective that will inform their protocols.”

During the ASCO/AACR Workshop on Methods in Clinical Cancer Research, held July 27-Aug. 2, 2019, several members of Big Ten universities and cancer centers participated as faculty and selected fellows.

Vail Workshop 2019 participants from Big Ten CRC member institutions included (top, l-r) Thomas Braun, PhD; Richard Chappell, PhD; (middle, l-r) Ruth O’Regan, MD; Roger Stupp, MD, Douglas Yee, MD; (bottom, l-r) Amit Kulkarni, MD; and Kristin Koenig, MD.

Faculty presenters included Thomas Braun, PhD, professor of biostatistics, University of Michigan School of Public Health, who presented “Phase 1 Trial Designs;” and Richard Chappell, PhD, professor in the Department of Biostatistics and Medical Informatics and the Department of Statistics at the University of Wisconsin Madison, who led the small group discussion “Imaging Endpoints” with Thomas E. Yankeelov, PhD, of the University of Texas at Austin.

Ruth O’Regan, MD, chief scientific officer of the Big Ten CRC and a medical oncologist at the University of Wisconsin School of Medicine and Public Health in Madison, Wis.; Roger Stupp, MD, chief of neuro-oncology at Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago, Ill.; and Douglas Yee, MD, medical oncologist at Masonic Cancer Center, University of Minnesota, in Minneapolis, Minn., each served as mentors and facilitated break-out sessions.

Dr. O’Regan said she was honored to be invited as faculty for this world-renowned workshop to provide expertise to some of the brightest, young investigators starting their research oncology career.

“This workshop is very competitive with only 1 in 3 applicants being accepted,” Dr. O’Regan said. “It offers a unique opportunity to develop a protocol with one-on-one mentorship as well as to spend time with experts in the cancer field.”

During the week, she and 5 other faculty members guided 8 trainees in their group in designing a cancer clinical trial.

“We provide one-on-one guidance both in a small group and in an individual setting,” Dr. O’Regan said. “Given that a major focus in the Big Ten CRC is mentorship of junior faculty, having our trainees and junior faculty involved in this workshop can support the development of investigator-initiated trials through the Big Ten CRC.”

She said having such good representation from the Big Ten CRC “speaks to the clinical expertise of Big Ten members.”

Fellows from Big Ten CRC member institutions who were selected to attend included Amit Kulkarni, MD, University of Minnesota Department of Medicine, Division of Hematology, Oncology and Transplantation; and Kristin Koenig, MD, The Ohio State University Wexner Medical Center, Divisions of Hematology and Medical Oncology.

“The Vail workshop provides a unique opportunity to meet, network, work very closely, and be guided by mentors and leading clinical trialists,” Dr. Kulkarni said. “I believe this is an ideal place to learn about principles of clinical trial design, get real-time feedback, and incorporate these to further optimize the clinical trial design.”

He said there were several takeaways in participating in the workshop, including an opportunity to take stock in how to strengthen the design of a clinical trial.

“No matter how perfect you think your trial protocol is before the workshop, it will change during the workshop,” Dr. Kulkarni said. “The process of interacting with leaders in the clinical trial design, statistical analysis, and biomarker assays helped open my mind to so many concepts. Participation in the workshop helped me better understand the pitfalls of my clinical trial design and steps that could be taken to address them.”

Dr. Koenig said she felt honored to be selected for the Vail workshop and was encouraged to apply by mentors and colleagues.

“They spoke very highly of the workshop and described the many ways it has been valuable to them early in their careers. I knew attending Vail would be an invaluable experience.”

She gained insight from faculty and advocates while attending the workshop, including the importance of keeping the patient at the center of one’s research.

“The ultimate goal is to improve patients’ lives, so this should be the overall goal of your research,” Dr. Koenig said.

— By Angie Antonopoulos

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit