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

▶

Nov 12, 2023 110 likes •335 views

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

SLIDE 1

A Clinical Research Perspective

Jennifer L. Marte, MD, MPH National Cancer Institute, NIH

SLIDE 2

Demographics
Treatment
Adverse Events
Labs/Radiology
Outcomes

SLIDE 3

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

SLIDE 4

SLIDE 5

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

SLIDE 6

Toxicity 2 – mild, at baseline Toxicity 2 – moderate, vaccine Toxicity 1 – severe, ADT vs. vaccine Toxicity 3 – severe, radiation

Scans Labs Labs Labs Labs Labs Labs Labs Labs Labs Scans Scans Scans Progression Off-Study

Death

SLIDE 7

Integrating complex data over multiple,

variable timepoints

Inconsistencies in data formats, even within

sources

Inconsistencies in patient identification
Demand for multiple, flexible output formats

SLIDE 8

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

SLIDE 9

SLIDE 10

SLIDE 11

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)

SLIDE 12

SLIDE 13

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

SLIDE 14

SLIDE 15

SLIDE 16

SLIDE 17

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

SLIDE 18



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

SLIDE 19

SLIDE 20

SLIDE 21