文档介绍：数据分析和大数据如何改变临床试验
Big data and analytics will make clinical trials systematically more accurate and efficient
Study Design & Feasibility
► Study
Planning &
Startup
Study Conduct
Statistical Analysis & Reporting
Success rate from Phase I to FDA approval is %
Probability of Success 2006-2015 (N = 9985)'
屮必 v Miiiiwi average cost to develop and gain marketing approval for a new drug2
On average, it takes at least
for a new medicine to complete the journey from initial discovery to the marketplace3
NDA/BL^ Approval Approval
Bigger Data
Better Data
Better Prediction
Better
Faster
Cheaper
Clinical Trials
Medidata has unmatched scale of data
-2,000
People
•ft -3,700,000
■HhI Trial subjects
18 of top 25 global pharmaceutical companies
>850
Customers
I -13,000
RM Sponsor/s,te
5 5" relationships
q rjQ i CROs. services, consulting.
'UUT technical partners
13 of top 15
setting drugs globally m 2017 were developed on Medidata technology
FDA Decision
Question
Challenge
New Approach
11
CSA: Machine Learning improves data quality and reduces risks to regulatory approval
Ineffective data
quality processes
How do we best
manage data
quality?
Significant time spent
on manual data
review
Long cycle times and
close out process
requires oversight
Unsupervised
statistical
techniques to
identify data
anomalies
Autocoder Overview
AE Verbatim
Match
Match
Left the tourniquet on long after surgery
Time of Final Incision Closure
Time of First Incision
CSA: Machine learning and outlier detection across your trial data
• Highly correlated surgery events (n # hours since ran domization)
• Anomalous data identified
Data Standardization
Adverse Event Verbatim Adverse Event Preferred Term
Abdominal bloatness Abdominal distension
Had blood in his stools - ► Haematorchezia
Hardening at injection site Injection site i