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

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

Categories of Open Clinical Trials

Treatment

SpecimenCollection

NaturalHistory

ImagingScreeningFollow-upPsychosocial

Epidemiology

Phase I

Phase II

Phase I/IIPhase III

Pilot

Laboratory investigator

Lab onlyLab space, technical support staff, operating budget

Clinical investigator

No labOperating budget, research nurse, data management

Heterozygous investigator

Lab + Clinical

Lab & clinical resources

CCR Investigators

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)

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

Criteria

Scientific contributionQuality, originality, and impact; upward trajectory

IndependencePrimary/senior authorship, distinct contribution

Recognition and leadershipLetters, invited talks, editorial boards, grant review panels, honors & awards, societies

Mentorship

Ethical conduct and citizenship

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

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

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

Challenges

Access to investigational agents/devices

Timelines for development, review, conduct and analysis

Referrals/accrual

Interactions with mentor and laboratory staff

Recognition and leadership

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.

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

Protocol Review

Investigator Investigator initiated protocolinitiated protocol

Branch ReviewBranch Review(scientific, priority, resources)(scientific, priority, resources)

Protocol Review & Protocol Review & Monitoring CommitteeMonitoring Committee

(scientific, statistical, priority)(scientific, statistical, priority)

SponsorSponsor (regulatory)(regulatory)

IRBIRB(safety, ethical)(safety, ethical)

Radiation SafetyRadiation Safety (safety)(safety)