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Data2Life
Real World Evidence –
The Holistic Approach and the Practice
Dorit Dekel Rotman
© 2017. DATA2LIFE LTD.
“THE FUTURE OF REAL-WORLD INSIGHTS (RWI) IS BEING PROPELLED BY THE COMBINATION OF INCREASINGLY ABUNDANT DATA (SUPPLY) AND RISING STAKEHOLDER REQUIREMENTS FOR
DEEPER INSIGHTS (DEMAND)”
Sources: “A new wave of innovation for real-world evidence", AccessPoint, Volume 7, Issue 13, May 2017. Quintiles IMS Health
Our Data VISION
3
Social Media WearablesGenomicePrescribingMonitoring
Devices
Big Data
Clinical Trial
Data
Medical
Claims
Clinical EHRsMedical
Literature
3rd Party
Regulatory
Reporting
Systems
Internal
Safety
Database
Individual
Case Safety
Reports
Internal
Connecting
the Dots
Generating
Actionable
Insights
Data
Digestion
Plenty of REAL WORLD DATA Need to REDUCE “TIME-TO-EVIDENCE”
4
Data CollectionNLP, Machine Learning, &
Algorithms
Dynamic
Semantic
System
Crawler &
Ingestion
Free
Text
Analytics
Pattern
Recognition
Data
Lake
Data Connections and
Knowledge Graph
Cross-
References
&
Ontologies
Cutting-edge Teck Stack & Process
Evaluation of Immuno-Oncology product – Use Case
5
CHALLENGE
Evaluate new Immuno-Oncology product to be introduced into the Healthcare
system / market
SOLUTION
OVERVIEW
Comparing the incumbent product to the new product in a safety prism
using evidence from real patients in other approved markets
Multi-source real world evidence report comparing multiple products based
on data generated by clinical EHRs and Spontaneous reporting systems
(AERS & social media)
Data Analyzed
6
100 PATIENTS
1,517 REPORTS
228 POSTS
Data Availability
2010 2013 2016
160 PATIENTS
1,367 REPORTS
487 POSTS
Data Availability
2010 2013 2016
Drug A
Drug B
Patient Characteristics
7
51%49%
Male Female
Sex Age (Y)
53%47%
Male Female
98
54
1
97
62
12
average
average
• Exposed population cohort defined
by exposure period algorithm.
• Age diagram displays the
minimum, maximum and average
ages of patients in the cohort.
• Indications sorted by diagnoses of
unique patients, stratified by sex.
Indication for Use
0%
10%
20%
30%
40%
50%
Cancer A Cancer B Other
Male Female
0%
20%
40%
60%
80%
100%
Cancer A Cancer B Other
Male Female
Clinical EHRs
ADHERENCE and SWITCHING Patterns
8
YERVOY (11.2%)
GEMZAR (21.5%)
SUTENT (13.1%)
VOTRIENT (12.1%)
12% switched FROM DRUG A to
45%switched TO DRUG A from
100 patients in cohort
NAVELBINE (10.3%)
YERVOY (34.5%)
TAFINLAR (13.8%)
TAXOTERE (10.3%)
AFINITOR (10.3%)
Clinical EHRs
49.551
50
Total Male Female
Average Duration of Therapy (Days)
Additional Therapy Factors
9
• Top 10 concomitant medications are
additional medications dispensed at the time
patient dispensed with the product of
interest
ROSUVASTATIN
(11%)
OMEPRAZOLE
(11%) (11%)
ATORVASTAT
IN
(22%)
INSULIN
ASPART
(25%)
RAMIPRIL
(9%)
METFORMIN
(23%)
INFLUENZA
VACCINE
(21%)
ROSUVASTATI
N
(14%)
SIMVASTATIN
(15%)
OMEPRAZOLE
(16%)
RAMIPRIL
(13%)
ENALAPRIL
(12%)
INSULIN
ASPART
(16%)
Top 10 Concomitant Medications
SIMVASTATIN
BISOPROLOL
(12%)
ENALAPRIL
(10%)
METFORMIN
(39%)
INFLUENZA
VACCINE
(29%)
ATORVASTATI
N
(33%)
BISOPROLOL
(17%)
Clinical EHRs
Quality of Life (QOL) and Serious Suspected Events
10
5.00%
4.40%
3.70%
2.77%
5.44%
1.12%0.99%
0.56%
25.02%
49.00%
Blindness Deafness Toxic optic neuropathy
Hepatic infarction Other serious events
51%49%
Serious
Events Distribution
Not serious
Serious
Clinical EHRs
of patients
experienced
medical events that
are considered
serious.
51%
5.00%
4.40%
3.70%
2.77%
5.44%
1.12%0.99%
0.56%
0.22%
1.00%
25.00%
Dyspnea Pain Nausea and vomiting
Appetite loss Constipation Diarrhea
25%
75%
QOL Events
Distribution
of adverse
events that are
considered as
quality of life-
relevant.
25%
Safety Report Submission Trends
11
Regulatory Spontaneous Reporting Systems
Patient Discussions
12
Treatment Recommendation
Quality Of Life aspects
Cost
Trials
Drug switch/stop
Concomitant
Adverse Events
Serious AEs
Personal
News / Informational
Questions
• Discussion types classify posts reporting
actual experiences of the author
("Personal"), news/articles mentioning
the drug ("News") and inquiries about the
product ("Questions").
• Treatment discussions indicate what
issues were discussed by the users, e.g.
clinical trials involvement, cost and
disease management aspects and advice.
• Product experiences are classifying the
posts mentioning events of Drug switch /
Stop, AEs and additional factors.
*these classifications are based on our IP algorithm employing tailored
machine learning and NLP to the complex context of medical /health and
therapeutics
Number of posts
0
20
40
60
80
100
120
Discussion Clasifications Treatment Discussions Product Experiences
Social Media
2
1
11
3
13
Drug Stop Insights– Drilling in
Drug Stop
No Response to Treatment
Disease related death
Adverse Events
Adverse Event
Pneumonitis
Gastro issues
Diarrhea
Blood pressure
Itching, rashes
Social Media
52
1
Drug Stop
Drug Stop Detailed Analysis
14
“I just started on DRUG Z and my tongue is swollen and getting worse every
day. Today I am calling the doctor about it and got this page when I googled
the symptoms. I have not had real good luck with adjunct chemo drugs
because of the side effects. I had to stop taking DRUG A because of
blood pressure issues and itching and rashes that were so bad
I couldn't sleep. I was red all over for a few weeks after going
off of it like I had a sunburn. So far after just one infusion of DRUG Z
I have the swollen tongue, mouth sores, and neuropathy of my right arm. The
day after chemo I had what felt like the flu without the fever but luckily it
was just for a day. I have flushing and sudden sweating for no reason where
my hair will get soaked with sweat and my face turns red. I also have been
itchy off and on but nothing like DRUG A itching. I'm staying on DRUG Z as
long as I can stand the side effects because I am only 52 with terminal lung
cancer and I want as much (time) as I can squeeze out of this cancer,
to spend with my son”
Social Media
Signal Detection Analytics
Disproportionality Analysis View
Data Source Filters
Signal Detection
Algorithms
Confidence Intervals
Hover Summary of Results
Summary view of Signal Scores
MedDRA Dictionary
SOC to PT Hierarchical
Browsing
Branching by Hierarchy
Change Views
Thank You!