July 1, 2014:

What type of trial is the Big Ten Cancer Research Consortium (BTCRC) looking to perform?

The BTCRC’s mission is to perform novel, hypothesis-driven, highly translational oncology trials. Two other important components in BTCRC trials is mentorship between junior and senior investigators as well as cross-collaboration between BTCRC institutions. See the complete list of Big Ten CRC Research Criteria.

How do I submit a concept to the BTCRC?

Download the 2014 RFA packet (Microsoft Word format). Complete the LOI and e-mail to Jessica Roy at jroy@bigtencrc.org.

Which working groups are currently active? How do I join a working group?

Nine clinical trial working groups (CTWGs) have been activated since October 2013: breast, gastrointestinal, genitourinary, gynecologic, lymphoid malignancies, melanoma/cutaneous oncology, multiple myeloma, myeloid malignancies, and thoracic. Contact Donna Sullivan at dsullivan@bigtencrc.org to join an existing working group or to inquire about launching a new working group.

When new concepts are received, they are assigned to the next CTWG agenda for group review and input. Ad hoc calls are arranged as needed. Concepts with majority approval will move into active development.

At what point should I submit my concept to the BTCRC?

The earlier the better! Administrative headquarters (AHQ) will assist you in drafting an initial budget, preferably prior to submission of an LOI to a potential funder. In addition, the input you receive from the working group strengthens the proposal, increasing the likelihood of an approved proposal.

Does the BTCRC provide funding for my trial?

No, not currently. Trials need to be fully funded to open within the BTCRC. However, funding may come from a variety of sources in order to fund all aspects of the trial (pharma, grant, foundation, etc.). BTCRC leadership are actively working on fundraising initiatives to supplement unfunded trial objectives in the future.

What assistance do you provide to the PI early in the trial process?

The BTCRC administrative headquarters provides comprehensive study support from conception and design through project completion and publication. Early in the process, staff are available to provide input on the LOI, draft the initial budget, upload and monitor the LOI submission, and survey BTCRC sites for interest and accrual estimates. Once the LOI is approved, staff are available to coordinate the construction of the final protocol and draft the informed consent document.

I’ve heard people talk about Hoosier Cancer Research Network. Who are they and how do they relate to the Big Ten Cancer Research Consortium?

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) is an independent nonprofit organization with 30 years of experience managing multicenter investigator-initiated clinical research trials. The Big Ten cancer center directors selected HCRN as the BTCRC’s clinical research organization (CRO) to provide centralized, standardized trial management of all BTCRC trials.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium creates a unique team-research culture to drive science rapidly from ideas to treatment-changing paradigms. 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 student-athletes’ lives and emphasize the values of integrity, fairness and competitiveness. The broad-based athletic programs of the 12 Big Ten institutions provide in excess of $141 million in direct financial aid to more than 8,200 student-athletes playing on more than 300 teams in 43 different sports. The Big Ten sponsors 26 official conference sports, 13 for men and 13 for women, and will add men’s and women’s lacrosse as the 27th and 28th official sports for the 2014-15 academic year. For more information, visit www.bigten.org.