CCR Clinical Research Priorities

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.

14. 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

15. 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)