1. An analysis of patient diversity in
oncology clinical trials
SAMIA ANSARI, UNIVERSITY OF GEORGIA
SARTOGRAPHY, LLC + OPENSOURCE CONNECTIONS, LLC
DATASTART WORKSHOP PRESENTATION 09.27.2016
2. How well are
women and
ethnic/racial
minorities
represented in
cancer clinical trials?
U. S. population
Cancer
incidence
Trial
Enrollment
3. Background: Clinical development
Only a small percentage of cancer patients participate
(Murthy, 2004)
Women and minorities underrepresented in biomedical
research (Oh, 2015)
Need to focus precision medicine initiatives like Cancer
Moonshot
4. Federal Classifications
Category Classifications
Gender • Male
• Female
Ethnicity • Hispanic
• Non-Hispanic
Race • Black
• White
• Asian/Pacific Islander
(API)
• American Indian (AI)
Used by NIH/OMB to
collect U.S. demographic
data
6. 3 datasets
Dataset Source Information
Surveillance, Epidemiology, and
End Results (SEER) Program
National Cancer Institute Cancer incidence rates
Aggregated Analysis of
ClinicalTrials.gov (AACT)
Clinical Trials Transformation
Initiative
Trial enrollment numbers
Bridged-Race Population
Estimates
U.S. Census Bureau and National
Center for Health Statistics
National demographic data
7. Parameters
2002-2012 enrollment period
5 cancer types
Lung, colorectal, ovarian, prostatic, breast
Omitted studies for which
no demographic data
categories that don’t map to NIH/OMB groups
multiple cancer types studied in one trial
8. Methodology
Estimate cancer diagnosis numbers for each
demographic group
Extract trial enrollment data from AACT database
Find any relationships between demographics and
enrollment status
13. Results – Race
0.0
5.0
10.0
15.0
All Lung CRC Breast Ovarian Prostatic
Proportion(%)
Cancer
API patient enrollment, 2002-2012
Proportion of trial enrollees Proportion of national incident cases Proportion of population
15. Lessons learned
Ethnicity and race data not adequately captured by trial
sponsors/AACT
Not enough ethnicity data
Limit customization of race/ethnicity fields
Trial sponsors should include yearly accrual numbers
16. Next steps
Build on initial analysis
Manuscript in progress
Possible collaboration
Applying for fellowships!
17. Additional information
Contact me!
khatsar@gmail.com
@sfansari
linkedin.com/in/samiaansari
angel.co/samia-ansari
Project blog
Blog posts on
OpenSourceConnections site:
Introduction to my project
Deploying the AACT Oracle database
using Docker
Learning the shape of my data
Expanding frequency data to case
form in R and STATA
18. Acknowledgements
Mentorship
Dan Funk (Sartography, LLC)
Eric Pugh (OpenSource Connections, LLC)
Dr. Joy Peterson (UGA BHSI)
Support
SouthBDHub DataStart Program
Computing Community Consortium
19. Sartography and OpenSource
Connections
Search analytics
Data visualization
Technical personalization,
recommendation systems
Clients include
NLM
NCBI
USPTO
Academic institutions
20. Bibliography
Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-,
and age-based disparities. Journal of the American Medical Association. Available
online: http://www.ncbi.nlm.nih.gov/pubmed/15187053/
OH SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, de Bruin DM,
Greenblatt RM, Bibbins-Domingo K, Wu AHB, Borrell LN, Gunter C, Powe NR,
Burchard EG. Diversity in Clinical and Biomedical Research: A Promise Yet to be
Fulfilled. PLoS Medicine. 2015; 12. Available online:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4679830/
U.S. National Library of Medicine. Data, Tools, and Statistics. NIH website. Last
updated: 11 April 2016. Available online:
https://www.nlm.nih.gov/hsrinfo/datasites.html
