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. Laboratory investigator Lab only Lab space, technical support staff, operating budget Clinical investigator No lab Operating budget, research nurse, data management Heterozygous investigator Lab + Clinical Lab & clinical resources 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. Tenure Review Process Lab/Branch Chief CCR SD CCR Clinical TRP NIH CTC Tenure package 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 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) (regulatory)IRB (safety, ethical) Radiation Safety (safety) (safety)