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CCR Clinical Research Priorities

CCR Clinical Research Priorities. Clinical research is an essential part of the CCR research program Translational (collaborative) Interaction between basic and clinical scientists Clinical outlet for discoveries in CCR labs Utilize unique features of Clinical Center

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CCR Clinical Research Priorities

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  1. CCR Clinical Research Priorities • Clinical research is an essential part of the CCR research program • Translational (collaborative) • Interaction between basic and clinical scientists • Clinical outlet for discoveries in CCR labs • Utilize unique features of Clinical Center • Complement extramural clinical research • Train clinical investigators

  2. Clinical Research in the CCR • Too few tenured, independent clinical researchers in the CCR • Critical mass of clinical researchers is required for a clinical research program • NCI commitment of resources to a tenured clinical investigator is less substantial • Recruitment of experienced clinical investigators has been difficult

  3. Categories of Open Clinical Trials

  4. CCR Investigators

  5. Clinical Research Infrastructure • Biostatistics & Data Management Section • Protocol Review Office (PRMC, IRB) • Clinical Trials Support (research nursing, staff development, data management, QA) • Clinical trials informatics (database) • Recruitment & outreach program (Call center, web-based advertising, continuing education) • NIH Clinical Center • Core facilities (PK/PD, cytogenetics, etc.) • Technology Development Branch • Advanced training (NIH/Duke program)

  6. Within 8 years of appointment • Recognized & productive research program • Favorable annual evaluations and BSC review(s) • Recommending memo (Branch Chief, SD) • C.V. and bibliography, 5 most important publications, reprints of 2 papers, future plans • BSC reports (within 2 years for CTC) • Resources (personnel, budget, space, etc.) • Letters of recommendation solicited • Presentation from Lab/Branch Chief • Seminar from tenure candidate Tenure Review Process Lab/Branch Chief Tenure package CCR SD CCR Clinical TRP NIH CTC DDIR

  7. Criteria • Scientific contribution Quality, originality, and impact; upward trajectory • Independence Primary/senior authorship, distinct contribution • Recognition and leadership Letters, invited talks, editorial boards, grant review panels, honors & awards, societies • Mentorship • Ethical conduct and citizenship

  8. Documentation Evaluated • NCI Tenure Review Panel • Lab/Branch Chief recommendation • C.V. and bibliography (5 most important publications, all protocol numbers and titles) • Future research plans (5 pages) • Site Visit reports and BCS recommendations • Resources (chronology) • List of leaders in the field (for letters of recommendation) • Central Tenure Committee • NCI TRP package (1-5 above) • NCI Tenure Review Panel report • Letters of recommendation (≥6) solicited by OSP/TRP

  9. Clinical Research • Clinical research protocols are extensively reviewed BEFORE they are conducted • Clinical experiments can not be repeated • Clinical research is collaborative • Multiple clinical investigators • Multiple institutions • Correlative studies in basic labs

  10. Tenure for Clinical Investigators • Applying the criteria (Scientific contribution, independence, recognition and leadership, mentorship, citizenship) to a clinical research portfolio • Expectations or benchmarks • Productivity • Independence

  11. Challenges • Access to investigational agents/devices • Timelines for development, review, conduct and analysis • Referrals/accrual • Interactions with mentor and laboratory staff • Recognition and leadership

  12. Concluding Thoughts • The NIH needs more independent clinical investigators. • TT investigators should develop a strategy to navigate the tenure track and achieve tenure. • The tenure review process needs to adapt the tenure criteria to apply to the pure clinical investigator.

  13. NIH Clinical Center (Your Lab) • Infrastructure for inpatient and outpatient clinical care (facility, nursing, labs, radiology, pharmacy, ICU, blood bank, medical records, etc.) • CC management fund from ICs through the “school tax” • CRC budget built from each department based on IC needs • CRC budget reviewed by CDs, SDs, CC Advisory Board, NIH Director ($336,000,000 for FY06) • Portion of CRC budget paid by each IC based on total IC intramural research budget (NCI accounts for 30%) • IC cost NOT based on use of CC

  14. Protocol Review Investigator initiated protocol Branch Review (scientific, priority, resources) Protocol Review & Monitoring Committee (scientific, statistical, priority) Sponsor (regulatory) IRB (safety, ethical) Radiation Safety (safety)

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