A Patient-Centered Approach to Enrolling Rare Cancer Patients in Clinical Trials

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Department of Health and Human Services
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Phase I
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DESCRIPTION (provided by applicant): Our new president vows to address the pervasive issue of cancer. Over 1.4 million Americans will be diagnosed with cancer this year, joining over 10 million living Americans who have experienced cancer. The medical cos ts of cancer care were 78 billion in 2008, and the overall economic impact was estimated to be over 200 billion. The current administration plans to double federal funding for cancer research within five years, primarily at NIH and NCI, with a focus on r esearch for rare cancers. Our expert collaborator on this project, Dr. Daniel Von Hoff, describes two classes of rare cancers. There are the truly rare diseases (e.g., hairy cell leukemia), but also common histological cancer types like breast cancer, wit h rare molecular subtypes such as triple negative breast cancer. Cancer profiling into these specific rare cancer sub-classes and customized treatment for individual patients is now clinically realistic. Challenges to the development of tomorrow's thera pies include identifying and connecting the right patients with the right treatments. Today, less than 5 percent of adult cancer patients participate in clinical trials. There are multiple reasons for this, including reimbursement problems in research fund ing, a daunting administrative burden, and a growing shortage of clinical researchers. The Obama administration has pledged to increase cancer trial participation to 10 percent of adult patients. In addition, the NCI Director has been charged with identify ing the regulatory barriers that prevent the timely completion of successful clinical research. Pharmatech Oncology has conceptualized a unique solution that identifies patients first (Just-in-Time , [JIT]), then rapidly connects patients and physicians t o appropriate clinical trial opportunities. This differs from the traditional model, which focuses initially on administrative process and secondarily on patient enrollment. The traditional model can be effective for clinical trials in indications with mil lions of patients, but for rare cancers, it is not as effective. The goal of this Phase I SBIR project is to assess the feasibility of using the JIT approach to efficiently enroll and conduct analysis of two or more ongoing or completed clinical trials fo r rare cancers, compared with the traditional model. We expect to demonstrate that JIT can increase enrollment rates while maintaining patient safety and data quality, which will lead to a Phase II project designed to fully demonstrate/validate JIT across a larger number and variety of rare-cancer trials and to show how JIT streamlines the administrative workflow. We intend to demonstrate how the JIT system can be applied to community-based and institutional sites-becoming a platform for matching individual patients anywhere in the country to appropriate clinical trials without the typical and potentially harmful administrative delays. The nationwide JIT initiative will enable patient access to NCI- and privately funded clinical trials, will improve overall and representative participation, and will boost access to cancer cures and to personalized cancer treatments. PUBLIC HEALTH RELEVANCE: Modern strategies for developing new, targeted cancer therapies and testing them in clinical trials increasingly focus on highly patient-specific molecular abnormalities-turning many cancer trials into what amount to rare cancer trials. Currently, these developments bypass the majority (85 percent or more) of candidate cancer patients because those patients go lar gely undetected, embedded in a nationwide, community practice treatment system that has limited access to clinical trials of targeted therapies. The overall goal of this multi-phase SBIR project is to develop, validate and commercialize Pharmatech Oncolog y's novel Just-In-Time method for facilitating rapid enrollment of rare-cancer patients, reducing administrative and technical barriers, and improving patient access to state-of-the-art cancer treatment through advanced, personalized-medicine clinical tria ls.

* information listed above is at the time of submission.

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