A Clinical Research Perspective Jennifer L. Marte, MD, MPH National - PowerPoint PPT Presentation

A Clinical Research Perspective Jennifer L. Marte, MD, MPH National Cancer Institute, NIH

• Demographics • Treatment • Adverse Events • Labs/Radiology • Outcomes

• De-identification • Quantitative vs. qualitative • Summary statistics over various groupings • Snapshot views of longitudinal data • Multi-site, multi-source

Scans Scans Scans Scans Labs Labs Labs Labs Labs Labs Labs Labs

Scans Scans Scans Scans Labs Labs Labs Labs Labs Labs Labs Labs Labs Death Toxicity 1 – severe, ADT vs. vaccine Progression Off-Study Toxicity 2 – mild, Toxicity 2 – moderate, at baseline vaccine Toxicity 3 – severe, radiation

• Integrating complex data over multiple, variable timepoints • Inconsistencies in data formats, even within sources • Inconsistencies in patient identification • Demand for multiple, flexible output formats

Input •  CRIS/BTRIS  Research databases – C3D, others (protocol/site-specific)  Excel spreadsheets  Hard copy  SSDI/Obituary databases Output •  Excel  STATA/SAS  Microsoft Word tables

Adverse Event # (%) of Injections Injection Site Reaction 72 (31.9) Fever 3 (1.3) Bone Pain 3 (1.3) Myalgias 2 (1.0) Diaphoresis 2 (1.0) Arthralgias 1 (0.44) Alkaline Phosphatase 1 (0.44) Inner Ear/Hearing 1 (0.44)

Patient ¡ Samples ¡ Flu ¡ PSA ¡ AAB3671 ¡ Pre ¡ 1/25,000 ¡ <1/200,000 ¡ D15 ¡ 1/37,500 ¡ <1/200,000 ¡ D29 ¡ 1/26,087 ¡ 1/100,000 ¡ D57 ¡ 1/24,000 ¡ 1/30,000 ¡ D85 ¡ 1/17,647 ¡ 1/14,634 ¡ T-­‑L3523 ¡ Pre ¡ 1/23,007 ¡ 1/120,000 ¡ D29 ¡ 1/16,216 ¡ 1/85,714 ¡ D57 ¡ 1/17,647 ¡ 1/40,000 ¡ D85 ¡ 1/28,571 ¡ 1/40,000 ¡ FLH3705 ¡ Pre ¡ 1/31,579 ¡ <1/200,000 ¡ D36 ¡ 1/50,000 ¡ 1/120,000 ¡ D57 ¡ 1/66,667 ¡ <1/200,000 ¡ D91 ¡ 1/64,154 ¡ 1/40,000 ¡ CJF3539 ¡ Pre ¡ 1/12,766 ¡ 1/200,000 ¡ D29 ¡ 1/11,111 ¡ 1/11,538 ¡ D57 ¡ 1/14,286 ¡ 1/35,294 ¡ D85 ¡ 1/14634 ¡ 1/66,667 ¡

A system for flexible, yet consistent, data entry that can • easily be updated A system that will allow for quantitative analysis of different • subgroups A system that would allow for selection and visualization of • individual patient data by variable, multiple categories A secure system which would allow authorized outside • users to access data – view/input A system which would allow for integration of data across • protocols

NCI-A-1 progression 2007-06-15  NCI-A-3 progression 2008-02-04  NCI-A-6 progression 2007-10-04  NCI-A-7 progression 2007-09-14  NCI-A-9 progression 2008-11-18  NCI-A-10 progression 2009-08-13  NCI-A-14 progression 2009-12-31  NCI-A-16 progression 2010-11-29  NCI-A-18 progression 2011-08-03  NCI-A-19 progression 2012-04-09  NCI-A-22 progression 2011-11-10  NCI-A-23 progression 2011-12-26  NCI-A-25 progression 2013-02-04  MDA-A-201 progression 2011-05-25  MDA-A-203 progression 2011-06-17  MDA-A-204 progression 2011-05-02  MDA-A-207 progression 2012-04-16  MDA-A-209 withdrawal 2011-09-19  MDA-A-210 progression 2011-11-29  MDA-A-213 allergy 2011-12-06  MDA-A-214 progression 2012-01-02  MDA-A-216 progression 2012-05-03  MDA-A-218 toxicity 2012-07-30  MDA-A-219 progression 2012-05-22  MDA-A-221 toxicity 2012-10-15 