Dec. 4, 2014:

In this month’s Q&A, Big Ten Cancer Research Consortium (Big Ten CRC) Administrative Headquarters addresses common questions related to regulatory and safety.

What are the responsibilities of Big Ten CRC regulatory managers?

Big Ten CRC regulatory managers assist with all aspects of regulatory issues related to Big Ten CRC research, including interactions with consortium members, institutional review boards, and regulatory agencies. Regulatory services include: Read More

Dec. 1, 2014:

A conversation with George Weiner, MD, director of Holden Comprehensive Cancer Center at the University of Iowa and the C.E. Block Chair of Cancer Research and professor of internal medicine at the University of Iowa. Dr. Weiner has led a statewide collaborative to reduce the burden of cancer in Iowa, served on committees within the National Cancer Institute, and just began a two-year term as president of the Association of American Cancer Institutes (AACI), which comprises 92 leading cancer research centers in the United States.

Q: What kind of impact do you see the Big Ten Cancer Research Consortium having on cancer clinical trials?

Every one of our institutions has an outstanding group of experts from a variety of specialties who work together to develop and test new ideas related to cancer prevention, early detection, and treatment. Can you imagine the difference we can make if we partner together? We will be able to share and test ideas quicker. It is imperative for us to do so. Research advances have demonstrated that cancer is much more complex at the molecular level than previously imagined. In essence, every cancer is unique and even the most “common” cancers are really rare cancers. This is both exciting and challenging. It is exciting because we are learning the best way to take care of cancer patients. It is challenging because finding enough patients who have the same molecular makeup to test new and promising treatments will be more difficult. To design better treatments in the future, scientists have to collaborate more than ever to assess our ideas. Working together, to partner on studies is going to be key to advance cancer medicine. Different from many other study consortia, the Big Ten Cancer Research Consortium will allow these multicenter trials to be done with a nimble organizational structure for optimal efficiency and scientific input. Read More

Nov. 14, 2014:

Today, the Big Ten Cancer Research Consortium introduces a new monthly feature highlighting news from our member institutions. We are proud to highlight each of our members, as we work together to improve the lives of all patients with cancer.

Several Big Ten CRC member institutions were profiled in US Airways Magazine’s October issue in an extensive feature on the Association of American Cancer Institutes. The featured institutions include the University of Illinois Cancer Center, the University of Iowa Holden Comprehensive Cancer Center, the University of Michigan Comprehensive Cancer Center, and the University of Wisconsin Carbone Cancer Center.

Following are selected updates from our member institutions.

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Nov. 1, 2014:

A conversation with Douglas Yee, MD, director of the Masonic Cancer Center, which is a member of the Big Ten Cancer Research Consortium.

Q: What strengths does the Masonic Cancer Center bring to the consortium?

At the University of Minnesota and at the Masonic Cancer Center, there is a very collaborative atmosphere. We act collectively with the goal to change cancer outcomes, versus looking to finish a task solely on our own. The leadership here will bend over backwards to help each other because that ultimately helps patients.

For example, I work mainly on breast cancer, and a colleague of mine focuses on HIV. He has studied mechanisms of resistance to HIV therapy and noticed that mechanisms involved in HIV drug resistance might also be implicated in the breast cancer mutational process. After confirming the similarities, and specifically a role for APOBEC3B, we received additional funding for further work on the role for this protein in the development of endocrine resistant breast cancer. Collaborating with colleagues in medicinal chemistry, we are developing small molecule inhibitors of APOBEC3B. If we can develop a drug to target this enzyme, then the consortium would be an ideal place to conduct the clinical trial validation. Everyone on this campus, no matter the center or school, thinks about how they can contribute to curing cancer. Read More

Oct. 1, 2014:

What are the responsibilities of Big Ten CRC project managers?

Big Ten CRC project managers coordinate and supervise the clinical trial from concept to close out. They serve as the main point of contact with pharmaceutical companies, physicians, and site staff. Project managers train all study staff on each protocol through a Site Initiation Visit (SIV). They also create and maintain a Study Procedures Manual (SPM) for each study. Read More

Oct. 1, 2014:

A conversation with Timothy L. Ratliff, PhD, Robert Wallace Miller Director of the Purdue University Center for Cancer Research, which is a member of the Big Ten Cancer Research Consortium.

Q: What kind of impact do you see the Big Ten Cancer Research Consortium having on cancer clinical trials?

The collaborative interactions among Big Ten cancer centers will enable more rapid testing of new therapeutics. In truth, the whole is greater than the parts. By combining forces, multiple institutions will participate in clinical studies, patient accrual will occur more briskly and, therefore, outcomes will be determined more rapidly. Read More

Sept. 1, 2014:

What is the process for submitting a budget with the LOI to the funder?

The process begins with the Principal Investigator sending the proposed Letter of Intent (LOI) or protocol to Big Ten CRC Administrative Headquarters (Admin HQ). Each PI completes a brief questionnaire regarding the different elements that the budget should include. Once all necessary costs are added into the budget, Admin HQ will send the budget, along with the LOI or protocol to the funder for review. Admin HQ will negotiate the overall study budget directly with the funder, and the contracts department will then generate and negotiate a work order with each participating institution for payments that the sites will receive for participating in the trial. Read More

Sept. 1, 2014:

A conversation with Howard Bailey, MD, interim director of the UW Carbone Cancer Center, which is a member of the Big Ten Cancer Research Consortium. Dr. Bailey, a professor of medicine, is a medical oncologist who specializes in gynecologic oncology and cancer prevention. He has led the development of three different state- and nation-wide clinical research networks to expand the access of “cutting edge” treatment for patients.

Q: What kind of impact do you see the Big Ten Cancer Research Consortium having on cancer clinical trials?

Without a doubt, the Big Ten Cancer Research Consortium will offer accelerated advancement when moving science into groundbreaking clinical trials. The consortium forms a strong collaboration because of the cancer advances each Big Ten institution has already made and the research infrastructures in place at each location. And we know the consortium will leverage and grow the existing relationships among cancer centers in development of clinical trials. This is a win-win for all of these institutions and more importantly, for all cancer patients that will be affected by the novel treatments of tomorrow. Read More

Aug. 1, 2014:

A conversation with Raymond J. Hohl, MD, PhD, director of Penn State Hershey Cancer Institute, which is a member of the Big Ten Cancer Research Consortium. Dr. Hohl joined Penn State Hershey from the Holden Comprehensive Cancer Center, University of Iowa, where he held the Holden Family Chair/associate chair of the Department of Internal Medicine, as well as associate director for clinical and translational research. At Penn State, he will hold academic appointments as professor in the departments of Medicine and Pharmacology.

Q: What kind of impact do you see the Big Ten Cancer Research Consortium having on cancer clinical trials?

The Big Ten Cancer Research Consortium allows investigators from Penn State Hershey Cancer Institute and the other Big Ten institutions to more rapidly advance their concepts to active clinic trials. Because the trials will be developed and performed by a more tightly knit group of like-minded investigators, it is expected that the time from idea to completion of the trial will be substantially shortened as compared to the national clinical trials network’s current approach. For the principal investigators, this will mean more rapid advancement of their careers. For our patients with cancer, this will result in even more therapies and treatment options. Read More

Aug. 1, 2014:

From a contracts perspective, what does a Big Ten institution need to do to open as a site in a Big Ten CRC study?

Each Big Ten CRC institution signed a master site agreement, called an Institutional Participant Agreement (the “IPA”), when it joined the Big Ten CRC. If an institution wants to participate as a site in a particular study, the AHQ will provide a study specific work order under the IPA. The work order will include a site budget and any study specific terms required by the study funder or sponsor investigator’s institution (e.g., study specific intellectual property terms). Read More