Partnering with the Biostatistics Center: Getting the most from your consultation Gayane Yenokyan, MD, MPH, PhD Executive Director, Johns Hopkins Biostatistics Center Department of Biostatistics

Outline Biostatistics Center as a resource for biostatistics and data management support Breadth and scope of our consultations Tips to make the most from your consultation

Johns Hopkins Biostatistics Center (JHBC): Who We Are The practice arm of the renowned Department of Biostatistics since 1997 Well-respected with a proven track record of collaborations Broad expertise in biostatistics and data management Coordinated team to provide comprehensive consulting in support of education, research and practice Range of levels and scope of support

Mechanisms of Consultation Clinical and translational research projects through the ICTR/Quantitative Methods Core by faculty who have % effort Fee-for-service (FFS) projects based on hourly rates Internal External Level of effort on grants

Biostatistics Clinical and Translational Research (BCTR) Quantitative Methods Core Biostatistics Program / BCTR Center for Clinical Trials and Evidence Synthesis Computational Medicine Computational Biology/Computational Genomics Free biostatistics and data management support to research faculty and staff primarily appointed at JHU Faculty and staff walk-in clinics ( ~ 30 minutes) ICTR requests for limited consultations (up to 5 hours)

Faculty and Staff Walk-In Clinics Available to JHU faculty and staff Including Post-doctoral Fellows and Residents 20 – 30 minute consultations Hours and locations: The clinics are held in the School of Public Health, 615 N. Wolfe St. Monday 1:00 p.m. - 2:00 p.m. (E3144) Tuesday 1:00 p.m. - 2:00 p.m. (E3144) Wednesday 11:00 a.m. - 12:00 p.m. (E3531) Thursday 11:00 a.m. - 12:00 p.m. (E3142)

Biostatistics and Data Management ICTR Requests Requests are assigned on rotating basis among MS / PhD BCTR faculty Expect 3-5 days between placing a request and initial contact Up to 5 free hours of biostatistics and data management help per project Consulting by phone, email, Skype, or in-person meetings

Biostatistics Consultation Focus I Research study design and protocol development for clinical trials and observational studies sample size calculations and power analysis randomization (from simple to block to complex minimization/covariate-adaptive randomization algorithms) sampling (e.g. nested, case-cohort, matched case-control studies) statistical analysis plans Statistical analysis and interpretation conference abstracts/posters/presentations and manuscripts interim/final analyses / stopping rules, DSMB reports, predictive modeling, data mining and model validation

Biostatistics Consultation Focus II Innovative/complex statistical methods adaptive clinical designs sensitivity analyses for missing data wearable devices Independent statistical reviews for manuscripts response to reviewers independent statistical reviews Manuscript preparation and scientific report-writing reproducible analysis and reports

Data Informatics Services Core (DISC) Review of database design and data collection instruments Developing custom data collection systems Preparing data for analysis and reporting multiple data sources analytic datasets from raw data data reconfiguration / formatting Administering and providing access and support to the REDCap (Research Electronic Data Capture) web application

JHBC Impact, 2012-2017 ~ 170 walk-in clinic consults/year: 60%-SOM ~ 200 consult requests/year: 70%-SOM; Top departments: DOM, Anesthesiology/Critical Care Medicine, Neurology, Psychiatry, Radiology Support for junior researchers: Asst Prof (24%), Postdocs (8%), Fellows (24%) Would recommend service to others: 86-91% (3 surveys) DISC: 300 REDCap research studies (2,100+ active users) Publications / Awards: Over 400 publications, 12K+ citations, awards (teaching, distinguished papers / posters)

Suggested timeframes for your biostatistics consultation Approach JHBC as early as possible! Abstract Preparation: at least 1 month New Proposal Development: at least 1 month Re-submissions: at least 2 weeks to improve scores Manuscript Development/Scientific Writing: 1 to 2 months Manuscript Review: a minimum of 2 weeks Data Analysis: depends on complexity of analysis /status of data

Getting the most from your biostatistics consultation: Sample Size Well-defined specific aims and primary outcomes Minimal practically/clinically meaningful difference Preliminary/pilot data and/or relevant literature on the topic Measures of variability on primary outcomes Idea about maximum sample size given the available resources. There will be several iterations of sample size – keep good communication with the biostatistician to manage expectations, deadlines and other important developments that affect the study

Getting the most from your biostatistics consultation: Data Analysis Provide well-defined specific aims, primary outcomes, and study design description Have a well-organized and documented dataset. Clarify work expectations in advance: Scope of work, deliverables Statistical software preference (STATA, SAS, SPSS, R) Timeline, any relevant deadlines

Contacts regarding BCTR/JHBC consultations Administrative Questions: Nita James Program Coordinator Office: (410) 614-2661 Email: jhbc@jhu.edu Research / Scientific Questions: Gayane Yenokyan JHBC Executive Director Office: 410 502 3828 E-mail: gyenoky1@jhu.edu