• Hospitals, Researchers and Advocates Come Together to Push Progress in Clinical Trials



    Guest blog by Kari Wojtanik, PhD, Manager, Evaluation and Outcomes

    Treatment of breast cancer has greatly improved due to lessons learned through clinical trials. Thanks to researchers and the bold women and men who are willing to take a chance, for themselves and for the future of breast cancer treatment, clinical trials have allowed researchers to test the safety and benefits of new drugs, diagnostic methods and screening tests. Findings from clinical trials today directly impact patients and dictate the standard of care.

    For some patients, like our very own Karen Durham, a member of Komen’s Advocates in Science Steering Committee, clinical trials are an everyday part of life. For more than six years, she has lived with metastatic breast cancer that has been kept at bay thanks to therapies that are being tested in clinical trials. Her participation not only impacts her life, but the lives of others who may someday be diagnosed with this disease.

    For Karen and many others, the quality and pace of clinical trials are vital to continuing our progress in the fight against breast cancer.

    I recently had a ‘behind-the-scenes’ look at the importance of clinical trials and how they are developed at the bi-annual meetings of the Translational Breast Cancer Research Consortium, more affectionately known as the TBCRC, along with one of my Komen colleagues, Kim Sabelko.

    The TBCRC is a group of 17 cancer hospitals and research centers across 15 states  that conduct innovative breast cancer clinical trials.  It consists of oncologists, surgeons, radiation oncologists, scientists, statisticians, study coordinators, and patient advocates – all of whom provide input into the development of every trial run through the TBCRC. Komen is one of three key sponsors of the TBCRC, providing $10 million since 2007 in support of this unique group.

    The goals of the TBCRC are to speed completion of clinical trials, share data and ultimately provide real impact for women and men with breast cancer.

    During the TBCRC meeting, I not only learned about the great progress TBCRC clinical trials have made, but also about the issues and challenges faced by those conducting the trials. And it’s no surprise: it takes a village to conduct a trial!

    Cooperation among a diverse group of experts, from researchers to advocates, with an equally diverse set of resources, is crucial for conducting a clinical trial. People, time, money, medical supplies, support systems, and a clear plan for completing the trial are all part of the clinical research infrastructure. But coordinating all of these components can be a daunting task for a single hospital or cancer center.

    That’s where the TBCRC comes in. The TBCRC provides the infrastructure needed to help its members conduct meaningful, successful clinical trials across multiple institutions that other groups or institutions may not be able to.

    One example of this is a TBCRC trial on male breast cancer. Because male breast cancer is not common, finding enough patients at a single, or even a few institutions, to adequately power a clinical trial can be near impossible. By having 17 institutions across the country, the TBCRC can provide the infrastructure needed for the trial, and more patients can be accrued, strengthening results.

    Any researcher would agree: clinical trials are becoming much more challenging in terms of data collection and recruiting eligible patients.  As a result, many trials can either be too intensive or too large, or have too few eligible patients, for a single institution to conduct. Because TBCRC organizations work together, trials conducted through the consortium take place across several institutions, instead of just one, increasing the power of the trial results.

    “The TBCRC fills a space in the breast cancer world that was entirely vacant, and with the decline in federal funding, work done by the TBCRC is more important than ever,” says Eric Winer, MD, one of the founders of the TBCRC and a member of the Steering Committee, as well as Komen’s Chief Scientific Advisor.  “And you can’t underestimate the importance of bringing investigators together from across the country to discuss new and ongoing trials,” Winer adds.

    All TBCRC clinical trials are driven by the most pressing questions in breast cancer. Attendees work together to make sure that the trials conducted through the TBCRC will answer important questions,  successfully recruit patients, and are designed to get meaningful results. They are not dictated by the interests of the biotech or pharmaceutical industry. This is possible thanks to support from various sources, including Komen.

    The TBCRC also serves as a training ground for next generation of breast cancer clinical researchers. As funding for cooperative and other groups dwindles, opportunities for researchers to conduct trials also diminish.

    “Today, younger investigators have fewer opportunities than ever to propose new concepts and successfully test them in clinical trials. The TBCRC offers them a safe harbor where their ideas receive early input from more experienced investigators, thereby increasing the chances of successfully completing studies that could influence routine clinical practice and serve as the foundation for larger scale clinical trials,” says Antonio Wolff, MD, TBCRC Executive Officer and a member of its Steering Committee, and a Komen Scholar. Wolff emphasizes,“The opportunity to be a part of a successful team early on is critical to ensure that the brightest and most productive minds continue a career in breast cancer research.”

    One of the highlights of the TBCRC meeting was when a medical oncologist from the University of Michigan approached Kim and me to say, “Thank you.” She conveyed the importance of organizations like Komen in supporting the TBCRC, and passed on the sentiments of her patients, who appreciated participating in a TBCRC trial that is supported by an organization they know and trust.

    We’re proud to support the TBCRC, as its members work to accelerate the clinical trials process and change the way many women and men with breast cancer are treated in the future.

    Stayed tuned for future updates on the TBCRC and results from TBCRC trials.

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