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The Language we requested was included in HR 2740 exactly as we requested.

House Budget Item Sponsored by Congresswoman Debbie Wasserman Shultz in HR2740

Clinical Trials for Primary Prevention of Breast and Ovarian Cancers: The conferees direct NCI to develop a “Request for Applications” (RFA) supporting expenses for phase I, phase II, phase II/III, and phase III clinical trials focused on primary immunoprevention of breast cancer and primary immunoprevention of ovarian cancer, i.e., prevention of these cancers in cancer-free subjects. Support will include costs related to GMP and GLP expenses, direct subject/patient expense reimbursement associated with enrollment, participation, retention, long-term patient outcomes, and long-term research outcomes. The trials will involve relevant underrepresented and minority communities. NCI is encouraged to develop the RFA in consultation with NCI-designated Cancer Centers, the National Clinical Trials Network, the NCI Community Research Program, and non-profit foundations currently working in this area. The conferees direct NCI to provide a description of its plans for this study to the Committees on Appropriations of the House of Representatives and the Senate within 90 days from the date of enactment of this Act.

The Approved Budget Language in final Budget by Senate: 

H.R. 1865 / Public Law 116–94

Gynecologic Cancer Clinical Trials.—NCI is encouraged to work with stakeholders to address priorities for the gynecologic oncology clinical trials scientific agenda, including consideration of the availability of trials for these patients.

The Net Result: 

We made progress but we still have much work to do. The most disappointing issue is the removal of the classification of research for primary prevention.  There was progress in identifying funding for gynecologic oncology clinical trials which are greatly needed.  We did achieve one small step forward, but we must continue efforts to obtain funds for primary prevention.

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