information and Pre-Programme

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REAL WORLD DATA EPIDEMIOLOGY: OXFORD SUMMER SCHOOL
11/07/2016 – 15/07/2016
CONFIRMED SPEAKERS
D Prieto-Alhambra (NDORMS, University of Oxford)
A Judge (NDORMS, University of Oxford)
PR Rijnbeek (Erasmus University Medical Center, Netherlands)
I Petersen (University College London, United Kingdom)
S Perez-Guthann (RTI Health Solutions)
I Douglas (LSHTM, London, United Kingdom)
E Molero (SYNAPSE Management, Spain)
Bart Vannieuwenhuyse (IMI-EMIF and Janssen Research and Development)
A Silman (NDORMS, University of Oxford)
R Pinedo-Villanueva (NDORMS, University of Oxford)
A Delmestri (NDORMS, University of Oxford)
J Leal (HERC, University of Oxford)
W Forrester-Barker (NDORMS, University of Oxford)
MS Ali (University Medical Centre Utrecht)
H Dorricott (CPRD, MHRA, United Kingdom)
A Bourke (THIN, IMS Health, United Kingdom)
K Bhaskaran (LSHTM, United Kingdom)
A Lübbeke (University of Geneva, Geneva Joint Arthroplasty Registry, Switzerland)
W Dixon (University of Manchester, United Kingdom)
T Duarte (SIDIAP, Spain)
G Collins (Centre for Statistics in Medicine, NDORMS, University of Oxford)
N Lea (University College London, United Kingdom)
Course Director & Co-Director:
Prof D Prieto-Alhambra, Associate Professor and Co-Chair of the Big Health Data User
Group, NDORMS, University of Oxford.
Prof A Judge, Associate Professor and Chair of the Big Health Data User Group,
NDORMS, University of Oxford.
Course administrator:
Ms Paloma O’Dogherty (paloma.odogherty@ndorms.ox.ac.uk)
Target audience: Pharmacists, clinicians, academics (including statisticians, epidemiologists,
and related MSc/PhD students); Industry (pharmacy or device) or Regulatory staff with an
interest in the use of routinely collected data for research.
Learning Goals: By the end of the course, delegates will:
1. Gain an understanding on the existing sources of routinely collected data for
epidemiological research
2. Be able to discuss common types of study and designs for the use of such data: a)
epidemiological research, b) prediction modelling, c) health economics, d)
pharmacoepidemiology, and e) device/registry epidemiology
3. Understand relevant issues and learn potential solutions applied to the use of big
health data: a) data management and information governance, b) interaction with
industry and regulators, c) stats/methods: missing information, bias, confounding,
misclassification
4. Learn introductory concepts of pharmacoepidemiology and medical device
epidemiology using observational, routinely collected or registry-based data
Dates: 11th of July to 15th of July 2015
Venue:
Jurys
Inn
Oxford,
Godstow
Rd,
Oxford,
OX2
8AL
(https://www.jurysinns.com/hotels/oxford)
Duration: 1 working week, 30 hours: (9.00h-12.30h + 13.30h-16.00h, Mon to Fri)
Registration: Places can be booked now throw the following link:
http://www.oxforduniversitystores.co.uk/browse/product.asp?compid=1&modid=5&catid=472
Registration will be on a ‘first arrived first served’ basis. The fees below cover refreshments
and lunch for five days (from the 11th to the 15th of July).

Early Bird (before 08/05/2016): £850 (Non for Profit organizations); £1,000 (For Profit
organizations).

Late Registration (09/05/2016 to 20/06/2016): £1,100 (Non for Profit); £1,300 (For
Profit).
For more information about the registration process, please contact the course administrator
(paloma.odogherty@ndorms.ox.ac.uk).
For enquiries about accommodation, please contact the hotel staff directly.
PRELIMINARY PROGRAMME
DAY 1 (11/07/2016): INTRODUCTION TO REAL WORLD DATA

09.30-10.00h: Registration, Housekeeping and Introduction/s

10.00-11.00h: Real world data sources. 10’ presentations from different data sources.
Chair: Daniel Prieto-Alhambra, Oxford
o
Introduction and Drug Utilisation Databases [D Prieto-Alhambra] 10’;
o
Primary Care: 2/3 examples [A Bourke IMS-THIN; A Gallagher CPRD; T Duarte
SIDIAP] 20’;
o
Drug and Device Registry/ies [A Silman, Oxford] 10’;
o
Hospital data: HES [A Judge, Oxford] 10’
o
QUESTIONS 10’
COFFEE BREAK: 11.00-11.30h

11.30-12.30h: Study Designs in RWD Epidemiology [I Douglas, LSHTM] 60’
LUNCH: 12.30h-13.30h

13.30-14.30h: INTERACTIVE SESSION (in groups) [D Prieto-Alhambra, Oxford and I
Douglas, LSHTM]
TEA BREAK: 14.30-15.00h

15.00-16.00h: A successful example (epidemiology): BMI and cancer [K Bhaskaran,
LSHTM]
DAY 2 (12/07/2016): INTRODUCTION TO PHARMACOEPIDEMIOLOGY

08.30h-09.00h – REGISTRATION

09.00h to 10.00h - Introduction to pharmacoepi 1: drug utilisation research and drug
safety studies [S Perez-Guthann, RTI H(s)] 45’ + Q&A 15’. Chair: D Prieto-Alhambra,
Oxford

10.00h to 11.00h - Introduction to pharmacoepi 2: sources of confounding and bias,
and how to best adjust for these [I Douglas, LSHTM] 45’ + Q&A 15’. Chair: A Judge,
Oxford
COFFEE BREAK: 11.00-11.30h

11.30h to 12.30h - Advanced Methods in Pharmacoepi: Propensity Scores and
Instrumental Variables [MS Ali, University Medical Centre Utrecht] 45’ + 15’ Q&A.
Chair: I Petersen, UCL
LUNCH: 12.30h-13.30h

13.30h to 14.30h – GUEST LECTURE: Multiple imputation of missing data [I Petersen,
UCL] 45’ + 15’ Q&A. Chair: S Perez-Guthann, RTI H(s)
TEA BREAK: 14.30-15.00h

15.00h to 16.00h - A successful example (drug safety) [S Perez-Guthann, RTI H(s)]
45’ + 15’ Q&A. Chair: D Prieto-Alhambra, Oxford
DAY 3 (13/07/2016): INTRODUCTION TO HEALTH ECONOMICS AND REGISTRIES

08.30h-09.00h – REGISTRATION

09.00-10.30h – Introduction to Health Economics in RWD. Chair: D Prieto-Alhambra,
Oxford.
o
Health economics in primary care databases [R Pinedo-Villanueva, Oxford] 40’
o
Health economics in hospital data [J Leal, HERC, Oxford] 40’
o
Q&A and Conclusions 10’
COFFEE BREAK: 10.30-11.00h

11.00-12.30h - Registries. Chair: A Silman, Oxford.
o
Drug registries: biologics [W Dixon, University of Manchester] 40’
o
Device registries: national joint/arthroplasty registry/ies [A Lübbeke, University
of Geneva, Geneva Joint Arthroplasty Registry] 40’
o
Q&A and Conclusions 10’
LUNCH: 12.30h-13.30h

13.30h to 14.30h - INTERACTIVE SESSION (in groups): Health Economics analyses
of RWD [R Pinedo-Villanueva, Oxford and J Leal, HERC, Oxford]. Chair: DPA.
TEA BREAK: 14.30-15.00h

15.00h to 16.00h - Two successful examples. Chair: A Judge, Oxford
o
Hospital costs of hip fracture [J Leal, HERC, Oxford] 25’
o
Cost-effectiveness of TKA/THA [R Pinedo-Villanueva] 25’
o
Q&A and Conclusions 10’
DAY 4 (14/07/2016): INFORMATION GOVERNANCE, DATA MANAGEMENT, AND
PREDICTION MODELLING

08.30h-09.00h – REGISTRATION

09.00h to 10.30h - Information Governance issues. Chair: Wulf Forrester-Barker
o
UK Perspective [H Dorricott, CPRD, London]. 40’
o
EU Perspective [N Lea, UCL]. 40’
o
Q&A and Conclusions 10’
COFFEE BREAK: 10.30-11.00h

11.00h to 12.30h - Data management. Chair: DPA
o
Automatic algorithms / data models for CPRD data [A Delmestri, Oxford]. 40’
o
Harmonization and quality checks for multi-database studies [P Rijnbeek,
Erasmus University]. 40’
o
Q&A and Conclusions 10’
LUNCH: 12.30h-13.30h

13.30h to 14.30h – Prediction Modelling using routinely collected data [G Collins,
Oxford]
TEA BREAK: 14.30-15.00h

15.00h to 16.00h – A SUCCESSFUL EXAMPLE: Jerboa, Octopus, and friends [P
Rijnbeek, Erasmus University]
DAY 5 (15th/July/2016): INTERACTION WITH INDUSTRY AND REGULATORS

09.00h-09.30h – REGISTRATION

09.30h to 11.00h - Working with Industry and Regulators. Chair: D Prieto-Alhambra,
Oxford
o
Regulators: what does the regulator need/value? [TBC] 40’
o
Industry: what are our needs? [Bart Vannieuwenhuyse, IMI-EMIF and Janssen
Research and Development] 40’
o
Q&A and Conclusions 10’
COFFEE BREAK: 11.00 – 11.30 h

11.30h to 12.30h –Project Management. Chair: A Judge, Oxford.
o
Project Coordination/Management: how can we help? [E Molero, SYNAPSE]
25’
o
The role of a honest broker: the EU-ADR Alliance [E Molero, SYNAPSE] 25’
o
Q&A and Conclusions 10’
LUNCH: 12.30h-13.30h

13.30h to 15.00h - OPTIONAL AFTERNOON TEA SESSION:
o
Q&A and Discussion with Course Directors [D Prieto-Alhambra, Oxford, and A
Judge, Oxford] and Tutors [R Pinedo-Villanueva, Oxford, and S Ali, University
Medical Centre Utrecht]
o
OR Networking / Business meetings
15.00h – Course Closure and Departure
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