Biostatistics, Epidemiology, and Research Design (BERD) Core

1. Biostatistics, Epidemiology, and Research Design (BERD) Core Dennis Lezotte, PhD – BERD Director Chair, Department of Biostatistics and Informatics (DL) and Nichole Carlson, PhD - BERD Co-Director Director, Colorado Biostatistics Consortium (NC)

2. ObjectivesCCTSI 2.0 • Objective 1: Collaboration and Consultation • Objective 2: Generate Reproducible Research • Objective 3: Application and Methods Research • Education: Provide biostatistics training opportunities

3. Governance • BERD Steering Committee: Overall advice and leadership for the BERD director and other BERD committees with particular attention to consistency across affiliate biostatistics groups. • BERD Methods Committee: Directs the MiTS groups to assure the continued development of biostatistics methods in translational science. • BERD Consulting- Resource Advisory Committee: Meets quarterly to provide: 1) guidance on how to best allocate consulting/collaboration resources, 2) monitor the implementation of current consulting/collaboration resource priorities, 3) review, as needed, BERD resource requests where established BERD priority is questionable. Voting members: 1 member each from Dept of Biostatistics, SOM (non-peds), Dept of Pediatrics.

4. BERD leadership • Dennis Lezotte has been directing the BERD since Spring 2013. • On July 1, 2013 Nichole Carlson was appointed associate/co-director of the BERD. • Dr. Carlson is transitioning to the BERD director position—NCATS has been notified and we are awaiting final approval. • Nichole is an Associate Professor in the Dept. of Biostatistics and Informatics. • She has been a collaborative biostatistician in Clinical and Translational research for over 15 years. • Her statistical research area is point process methodology applied to analyzing reproductive and stress hormones and more recently, lung CT scans. • Jane Gralla leads the Children’s Hospital Research Institute (RI) biostatistics group and manages the RI-BERD biostatistics resource interface.

5. Approach: Collaboration/Consultation Formalize relationship with the Colorado Biostatistics Consortium and Children’s RI biostatistics core to: • Have adequate capacity and expertise to provide biostatistics for the “unfunded” aspects of clinical and translational research. • Study design (sample size justification) • Develop data analysis plans • Conduct data analysis for pilots and small underfunded research grants • Career development for junior faculty

6. Seed collaboration formation by: • Matching a biostatistics faculty and student point people to groups conducting clinical and translational research with a focus on project development. • Train the next generation of biostatistics with expertise in clinical and translational research through practice based learning opportunities. • Match students with BERD/CBC faculty through apprenticeships • Work with biostatistics consulting curriculum to rotate student through the CBC.

7. Historical Approach: • Had a large BERD consulting/collaboration capacity • ~3 FTE of faculty • ~1.5 FTE of graduate student apprentices • Additional SOM support ($100K/yr) • Biostatistics resource was no cost to investigators. • Managing demand was main challenge. • Limitation of this approach: • Many investigators don’t realize the cost of having capacity available to help when they need it. • Current challenge, maintain existing capacity and grow new areas of expertise with declining BERD underwriting and reduced SOM direct support.

8. New Consulting/Collaboration Approach: • Strategy 1: Further leverage CBC and RI infrastructure. • Working a MOU with CBC to provide biostatistics consultation/collaboration for the CCTSI/BERD. • Will allow for cost shifting of administration and share administrative costs across all biostatistics consulting/collaboration conducted at AMC. • This will allow us to preserve more consulting budget.

9. Strategy 2: Raise awareness of the cost of biostatistics consultation and collaboration development • New project management • Investigator submits a request. • Director responds within 1-2 days. • One hour meeting, scope of work and cost estimate is developed • CBC biostatistician is assigned by Director to collaborate on the research. • Under current budget, CCTSI/BERD program covers 75% of $100/hr cost for approximately 40 hours of work (more if students used). • BERDSeeds program covers the other $25/hr cost for an additional $1000 of support for junior faculty. ($25,000 support from SOM)

11. Strategy 3: Develop a transparent priority matrix

12. Strategy 4: Match BERD $ with Dept/Division/Center $.

13. Operationalizing Matching • For matching to be available BC-RAC committee and EAC would need to approve groups as meeting the strategic goals and initiatives of the CCTSI. • Contracts written so access to CCTSI match requires dept/division funds are used. • CBC provides usage metrics. • Annually revisit contracts and matching funds available.

14. Objective 2: Reproducible Research • Develop a platform for biostatisticians • Assign a % FTE of Peter DeWitt (Biostats PhD student) • Develop training and make platform • We are also providing new support for • REDCap database formation (shared initiative with informatics) • ClinicalTrials.gov (shared contribution from institution) • Pre-review of protocols

15. Metrics: Collaboration/consultation • BERD provides 3.8 FTE of central support. • Impact of BERD Funding on UCD Research Enterprise • 11+ Biostatistics Faculty on 8.0 FTE Extramural Funding • Able to partially support 5 RA-ships graduate students. • # BERD SEEDS ~$12,500 allocated for 25 projects. • Projects requested ~100 projects requested support August-today

16. Metrics: Education • Seminars (10 topics covering full range of research development to analysis): • Monthly seminars (30-60 attend each month) • Short course (6-week intro to biostatistics): • ~30 attended • Still a wait list each session

17. Response to EAC Critiques • Place priority on good science • Developed priority matrix • BC-RAC to off-load decisions from biostatistician • Lack of adequate institutional support • Developing transparent business plan. • Matching leverages BERD resources to obtain additional resources from users. • Additional resource tracking created.

18. Response to EAC Critiques • Indirect Cost Recovery • Putting systems in place to track grants. • Using BERD/CBC administration to model how to collect collaborative ICR • Letter from CCTSI EAC in support of ICR sharing • Dean Goff has proposed hiring plan for collaborative biostatisticians • Would result in 2 additional FTE annually of additional capacity in strategic areas and 5 new hires over 5-7 years. New areas of expertise can be targeted.

19. Questions for EAC • Comments on Priority matrix • Opinions on how to reduce BERD contribution to biostatistics collaboration/consulting resource • Reduce portion of support (reduce 75% commitment) • Reduce priority • Approaches to protect BERD FTE for additional Aims • Reproducible Research • Application and Methods Validation/Development • Education