Presentation - Adaptive pathways workshop (Alison Cave)

34 Pages·2016·2.03 MB·English

by  European Medicines Agency

Objectives
11 2 3 44 5
Opportunities Data:
where RWE can strengths,
Which Data? Examples Conclusions
support the AP limitations
approach and challenges
1
Objectives
11
Which Data?
2
Which Data?
Which
Data?
Epigenetics
Transcriptomics
Genomics
Proteomics
Functional 
RCTs Phenotypes
Metabolomics
Pharmaco 
Lipidomics In silico 
genomics
Social  modelling
Media
Structural 
M‐Health
biology Electronics 
Surveys
health recordsRWE
Real world data
Environmental  Claims  is defined as data that are collected
data Registries
databases
outside the constraints of conventional
randomised clinical trials.
3
Which Data?
Electronic
health records
Primary care data, hospital records
Patient and
Claims data
caregiver surveys
Registries
Existing disease
The Future
Registries / new
Social media
product registries
data
DDaattaassoouurrcceess
Prescription databases Patient derived data
Drug utilisation (via smart phone or web
based technologies)
4
Patient Driven Platform for RWE – the future
Julian Isla
5
Objectives
11 2
Which Data? Examples
6
RWE is already in routine use in the EU
Particularly true for marketed products - safety monitoring
and drug utilisation.
7
Post-authorisation safety
Examples
• RCT suggested increased fracture risk
in women at arm, wrist, hand & foot.
• Electronic health records – GPRD
• 1819 patients were included with well
defined exposure and a fracture.
• Increased fracture risk with exposure
to rosiglitazone and pioglitazone, in
both men and women and at a range
of fracture sites.
8
Post-authorisation safety
Special
needs/disability
registers linked to
immunisation records
9
Observational studies supporting withdrawals/restrictions
10