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John Parkinson PhD Director, GPRD Seconded Expert- Research Capability Programme

John Parkinson PhD Director, GPRD Seconded Expert- Research Capability Programme. Medicines. Devices. Borderline. Herbals. Blood. DATA- GPRD…. Inspections & Standards. UK PV/PE Scene. United Kingdom. UK Health Care. NHS- 99.9% of people Registered with one GP practice

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John Parkinson PhD Director, GPRD Seconded Expert- Research Capability Programme

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  1. John Parkinson PhDDirector, GPRDSeconded Expert- Research Capability Programme Medicines Devices Borderline Herbals Blood DATA- GPRD… Inspections & Standards UK PV/PE Scene

  2. United Kingdom UK Health Care • NHS- 99.9% of people • Registered with one GP practice • Transfer to another with longitudinal record GP2GP • All but 2 practices (9000+) have e- records • Essentially only 4 GP IT systems • Problem based • And or Record based • Many are paperless or paper light • GP is gatekeeper • Apart from emergency care, no access anywhere else • Key secondary and other care data flows back to GP who enters into EHR • Except when in hospital/day care- all drugs via GP • Unique NHS ID- NHS# 10 numeric • BUT • 4 Health Services • England 80%, Scotland 10%, Wales, 4%, NI 3% • Research Capability Programme- England - • Connecting for Health (CfH)- English NHS IT project (£12 Billion) • UK Clinical Research Collaboration (UKCRC) • Office of Central Coordination of Health Research (OSCHR) • National Institute for Health Research (NIHR)

  3. United Kingdom Drug Exposure • 95% of all drugs Rxed by GP • Primary care • Secondary care recommendation • Post hospitalisation • 5% administered in hospital setting • In Hospital • Cancer Day care • Some highly specialist drugs • 2010 person level data • Dispensed data staring 2010

  4. United Kingdom Events • GP records • All Events- (READ) • Consultations • By email, letter, phone • Primary hospital discharge summary (TEXT to READ) • GPRD (5% sample UK) 60 billion events over 23 years • Hospital Episode Statistics • All events (ICD10) • 99.9% cover • Death data • 90-95% in GP record • Fully in central linkable record

  5. United Kingdom UK Health Research….Datatoday • GPRD • 5% UK sample • High quality longitudinal data • 2.8 billion events (41M BMI), 12 million n ever, 3.5 M active • Linked to • Full admin Hospital data (HES) ICD9, OPCS4, dates by ward • Full detailed CVD record (MINAP) • Full Cancer registry data • Central Death data • 2010 Hospital and day care Rx (admin)

  6. OSCHR United Kingdom SHIP 8% 5M NI 3% RCP 80% 50+M SAIL 4%

  7. ENGLAND RCP • Max collection of Primary Care data • Some in near real time • Essentially FULL all person EHR • All Lab tests • All life style • All events • Linked with • Central Death data (99.9%) • Central Hospitalisation (99.9%) • Key disease registers (40) • MINAP Cancer Implants • BIOBANK (500,000) • Central single point Clinical Trial system 50+Million Research Capability Programme Health Research Support Service

  8. United Kingdom UnderlyingPrinciplesofPV/PE

  9. United Kingdom SIGNALS Hypothesis Generation 1st 3rd 2nd Hypothesis Strengthening Hypothesis Testing Longitudinal Data SIGNALS Longitudinal Data PHASE 3 CT data

  10. United Kingdom N exposed Power for HYP. Testing EPI study 10,000s 1000s Exposure required for Hyp. Strengthening 100s 0 Yr4 Yr2 Yr3 Yr1 Years post launch

  11. B B A United Kingdom Data Mining and Hypothesis Testing in One dataset Random Split =

  12. United Kingdom UK Hypothesis generation SIGNALS • Yellow Card system- paper based • Doctors • Health Care Professionals • Patients • eYellow Cards • Fully embedded within EHR systems • Expert system • Auto-filled in with key details • Comments added • Sent in over NHSnet • “Conversation” possible

  13. United Kingdom UK Hypothesis Strengthening Longitudinal Data SIGNALS PHASE 3 CT data • On day 1 of a new product • RR from Phase 3 studies modelled with real world data • Uses ExEtrac methodology • Better contextualisation of signal data

  14. Clinical Trial Real World Risk Benefit United Kingdom Outline methodology ExEtrac • Relevant RRs from Phase 3 trials • Real/observed incidence rates –on treatment • Derived real world “non Treatment” rates • Attributable (absolute rate)= treatment R- non T R • (Causal) • What if true • Model uncertainty • Weighted Risk to Benefit • QOL can also be involved Relative Absolute

  15. Clinical Trial Real World Risk Benefit Excess number of cases in 10,000 HRT users (age 50-59) Benefits Risks Relative Absolute

  16. Clinical Trial Real World Risk Benefit Excess number of cases in 10,000 HRT users (age 70+) Benefits Risks Relative Absolute

  17. United Kingdom Risk-benefit acceptability curves by age (5 year HRT use) % population 40-49 50-59 60-69 70+ Risk Minimisation Plan Risks Benefits Cases/10,000 [5yrs]

  18. United Kingdom Randomisation in everyday clinical care • Confounding/ channelling • Possible because of eHR • Modified IT system for auto-prompt • Randomisation across web • Data collection in EHR • Wait for events • Low cost- big Ns possible • 3 studies in GPRD network, funded and in final planning

  19. United Kingdom Summary • Encourage more GP, HC professionals to report ADRs- Yellow Cards • Auto- e Yellow cards • Full EHR/ linkable data • Better contextualisation of YC data • Risk Management – new products • ExEtrac methodology • Earlier licensing- full n follow up • Rando. In every day care • Full exposure record including Phase 3 CTs.

  20. Quality United Kingdom Clinical Trial Relative Risk Benefit Absolute Real World

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