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A Review of the Committee Nomination and Review Process

A Review of the Committee Nomination and Review Process. Nancy S. Green, MD Associate Dean for Clinical Research Operations Associate Professor of Clinical Pediatrics, Division of Hematology Associate Director, Irving Institute for Clinical Translational Research

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A Review of the Committee Nomination and Review Process

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  1. A Review of the Committee Nomination and Review Process Nancy S. Green, MD Associate Dean for Clinical Research Operations Associate Professor of Clinical Pediatrics, Division of Hematology Associate Director, Irving Institute for Clinical Translational Research Columbia University Medical Center ACHDNC 8-7-08

  2. ACHDNC Evidence Review Process: Overview Advisory Committee Nomination Form HRSA Administrative Review Nomination Review and Prioritization Workgroup (NRPW) • Possible Recommendations: • Universal NBS • Targeted screening • Pilot study • Critical studies needed • No recommendation • Recommend against NBS Possible Further Study(ies) External Evidence Review Workgroup (ERW)

  3. ACHDNC Evidence Review Process: Subset Nomination Form Advisory Committee* HRSA Administrative Review • Criteria Workgroup: • Nomination • process and form Committee Chair Nomination Review and Prioritization Workgroup (NRPW) *Only the AC may make binding decisions External Evidence Review Workgroup (ERW) [Dr. Perrin] • An AC sub-group • Task: Readiness for EBR? • - Criteria • - Recommendation to AC • An Independent group • Tasks: Formal EBR • - Define terms and criteria • - EBR report

  4. Nomination Review and Prioritization Workgroup:Is a Nominated Condition Ready for EBR? 1) The nominated condition(s) is medically serious. 2) Prospective pilot data (U.S. and/or international) from population-based assessment are available for this disorder. 3) The spectrum of this disorder is well described, to help predict the phenotypic range of those children who will be identified based on population-based NBS. 4) There is a screening test that is capable of identifying the condition. 5) If the spectrum of disease is broad, those who are most likely to benefit from treatment are identifiable, especially if treatment is onerous or risky. 6) There are defined treatment protocols, FDA approval/clearance (if applicable) and availability of treatment. Overall recommendation to the Advisory Committee by the NRPW: 2 options: Ready for EBR or Not Ready for EBR, with rationale

  5. Nomination Review and Prioritization Workgroup: Nominated Conditions Considered to Date for EBR • SCID – Ready for EBR – under review • Pompe - Ready for EBR – under review • Krabbe – Ready • Fabry – Not ready • Niemann Pick – NRPW review pending

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