Real World Data Epidemiology: Oxford Summer School


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

Target audience:
Pharmacists, clinicians, academics (including statisticians, epimiologists, 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:
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) predictive 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

Venue: Jurys Inn Oxford, Godstow Rd, Oxford, OX2 8AL

Duration: 1 working week, 30 hours: (9.00h-12.30h + 13.30h-16.00h, Mon to Fri)

Registration: 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 organisations); £1,000 (For Profit organisations). – 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.

For enquiries about accommodation, please contact the hotel staff directly.

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 (DPA)
o Introduction and Drug Utilisation Databases [DPA] 10’;
o Primary Care: 2/3 examples [A Bourke IMS-THIN; (speaker tbc) CPRD UK; and (speaker tbc) SIDIAP] 20’;
o Drug and Device Registry/ies [A Silman, Oxford; tbc] 10’;
o Hospital data: HES [A Judge] 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) [DPA and I Douglas]
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: DPA * 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
COFFEE BREAK: 11.00-11.30h * 11.30h to 12.30h – Advanced Methods in Pharmacoepi: Propensity Scores and Instrumental Variables [A Sanni Ali, 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 P-G, 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: DPA

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: DPA, Oxford.
o Health economics in primary care databases [R Pinedo-Villanueva, NDORMS, 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 [TBC] 40’
o Device registries: national joint/arthroplasty registry/ies [TBC] 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 P-V and J Leal]. Chair: DPA.
TEA BREAK: 14.30-15.00h * 15.00h to 16.00h – Two successful examples. Chair: A Judge:
o Hospital costs of hip fracture [J Leal] 25’
o Cost-effectiveness of TKA/THA [R P-V] 25’
o Q&A and Conclusions 10’

DAY 4 (14/07/2016): INFORMATION GOVERNANCE, DATA MANAGEMENT, AND PREDICTIVE 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: tbc. 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]. 40’
o Harmonization and quality checks for multi-database studies [P Rijnbeek]. 40’
o Q&A and Conclusions 10’
LUNCH: 12.30h-13.30h * 13.30h to 14.30h – Predictive Modelling using routinely collected data [tbc]
TEA BREAK: 14.30-15.00h * 15.00h to 16.00h – A SUCCESSFUL EXAMPLE: Jerboa, Octopus, and friends [P Rijnbeek]

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: DPA
o Regulators: what does EMA need/value? [tbc] 40’
o Industry: what are our needs? [Bart Vannieuwenhuyse] 40’
o Q&A and Conclusions 10’
COFFEE BREAK: 11.00 – 11.30 h * 11.30h to 12.30h –Project Management. Chair: AJudge? tbc
o Project Coordination/Management: how can we help? [E Molero] 25’
o The role of a honest broker: the EU-ADR Alliance [E Molero] 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 [DPA, AJ] and Tutors [RPV, AS]
o OR Networking / Business meetings

15.00h – Course Closure and Departure