Enhancing the Collection and 

Availability of Demographic 

Subgroup Data 

John Whyte, MD MPH
 

Director
 

Professional Affairs and Stakeholder Engagement (PASE)
 
 

 

 

 

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Overview 

What are Drug Snapshots? 

Why are Drug Snapshots necessary? 

What is included in Drug Snapshots? 

How are Drug Snapshots different than the Package 

Insert? 

What is the timeline for publishing Snapshots? 

What are key findings? 

What are the latest updates? 

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Snapshots Brief History 

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2014: Pilot Program 

January 1, 2015: Snapshot written for every 

New Molecular Entity (NME) and Original 

Biologic approved 

Permanent program 

Goal to publish 30 days after approval 

Does not apply to previously approved drugs
 

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Purpose of Drug Snapshots
 

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Provide Information to the public about who 

participated in the clinical trials for NMEs and 

original biologics 

Also includes information on study design, 

results of efficacy and safety studies, and 

whether there were observed differences in 

efficacy and side effects among sex, race, and 

age subgroups 

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Drug Trials Snapshots 

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fda.gov/drugtrialssnapshot
 
 

Snapshots Audience 

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Consumers 

Physicians, Statisticians, anyone who is
 

nterested in the data and analyses
 

– (MORE INFO) 

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Snapshots are not a drug label
 

Snapshots 

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Intended for public 

Consumer-friendly language

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Focus on subgroup data and 

analysis 

Links to FDA reviews 

30 days after drug approval
 

Prescribing Information 

Intended for healthcare 

professionals 

Technical language 

Comprehensive resource 

for drug information
 

Not linked to FDA reviews
 

Published with drug 

approval 

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Drug Trials Snapshots 

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Summary of information 

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What is the drug for? 

What are the benefits of the drug? 

What are the possible side effects?
 

How were the clinical trials designed?
 

Demographic Information 

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Key Snapshot Questions:
 

Subgroups
 

Who were in the clinical trials by sex, race, 

and age subgroups? 

Were there observed differences in efficacy 

and safety among sex, race, and age 

subgroups? 

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Snapshots: Sex Demographics
 

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Snapshots: Sex Demographics
 

Tagrisso Baseline Demographics 

Approved December 2015 

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Snapshots: Racial Demographics
 
Snapshot Overview
 

AGE AFRICAN WOMEN ASIAN WHITE 65 AND AMERICAN OLDER 

AVERAGES 46% 8%12% 76% 26%

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Snapshots on Cardiovascular
 

BRAND NAME INDICAT ION WOMEN 

UPTRAVI Pulmonary arterial hypertension 80% 

REPATHA Hypercholesterolemia (HoFH) 50% 

SAVAYSA Reduce risk of pulmonary embolism in VTE patients 43% 

PRALUENT Hyperlipidemia 40% 

SAVAYSA Reduce the risk of stroke in a Afib patients 38% 

KENGREAL Blood thinner following heart procedure 28% 

CORLANOR Heart failure 24% 

ENTRESTO Heart failure 22% 

AVERAGE 41% 15 
 

 

 

 

 

 

Snapshots in Oncology
 BRAND NAME INDICAT ION WOMEN AFRICAN 

AMERICAN ASIAN WHIT E AGE 65 and OLDER 

IBRANCE Breast cancer 100% 1% 6% 90% 47% 

TAGRISSO Lung Cancer (T790M+, NSCLC) 68% 1% 60% 36% 45% 

ALECENSA Metastatic NSCLC 56% 2% 19% 74% 13% 

YONDELIS A dvanced sof t tissue sarcoma 52% 0% 9% 81% N/A 

LENVIMA Thyroid cancer 49% 2% 18% 79% 40% 

FARIDAK Multiple Myeloma & other cancers 48% 5% 29% 64% 42% 

DARZALEX Multiple Myeloma 46% 10% 6% 76% 45% 

NINLARO Multiple Myeloma 43% 2% 9% 84% 58% 

COTELLIC Melanoma 42% 0% 0% 93% 27% 

UNITUXIN Neuroblastoma 40% 7% 3% 82% N/A 

EMPLICITI Multiple Myeloma 40% 4% 10% 84% 57% 

LONSURF A dvanced metastatic colorectal cancer 39% 1% 35% 58% 44% 

ODOZMO A dvanced basal cell carcinoma (BCC) 37% 0% 0% 94% 54% 

PORTRAZZA 

Metastatic squamous non-small cell lung cancer (NSCLC) 17% 1% 8% 85% 39% 

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Platform for Important Questions
 

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Is there enough data to make conclusions 

about efficacy and safety for all subgroups? 

How many patients per subgroup are needed?
 

When is generalizability ok? 

When differences among subgroups are seen, 

when are differences clinically meaningful?
 

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Recent Activity 

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Total of 57 Snapshots 

Over 123,718 people visited the site since launch of the website
 

These people generated 101,447 visits to the site (some came 

more than once) 

The average visit lasted 2:10 minutes 

The top 5 Snapshots visited were Jublia, Lonsurf, Savaysa, 

Kybella, and Cosentyx 

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Future Steps
 

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Snapshots have created more questions 

“What is the right number?” 

Duke Margolis Meeting 

Continuing to improve and streamline process 

for generating Snapshots 

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Looking Forward 

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Continuing discussion on variability in
 

response to drugs among subgroups
 

Deeper understanding of when subgroup 

differences are plausible 

Best practices for reporting subgroup 

differences to the public 

Commitment to continued transparency
 

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Questions? 

John.W hyte@fda.hhs.gov
 

www.fda.gov/drugtrialssnapshot
 

Snapshots@fda.hhs.gov
 

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