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Aligning on Patient Outcomes - How Market Dynamics Can Facilitate RWD Solutions

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PAREXEL's Michelle Hoiseth on how pharmas can leverage Real-World Data to help improve patient outcomes.

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Aligning on Patient Outcomes - How Market Dynamics Can Facilitate RWD Solutions

  1. 1. © 2017 PAREXEL INTERNATIONAL CORP. ALIGNING ON PATIENT OUTCOMES – HOW MARKET DYNAMICS CAN FACILITATE RWD (REAL WORLD DATA) SOLUTIONS IN RESEARCH Michelle Hoiseth Corporate Vice President Real-World Data Services 14th November 2017
  2. 2. © 2017 PAREXEL INTERNATIONAL CORP. / 2 OUTCOMES ARE THE SINGLE COMMON DEFINITION OF VALUE TO PATIENTS, HEALTHCARE PROVIDERS AND PHARMA • Identify actions that can be taken today to leverage RWD while larger, structural changes take root • Become more agile in the complex regulatory environment to ensure RWD strategy remains relevant to review requirements • Accelerate the progression of RWD use by giving patients the ownership of their data AGENDA AND DISCUSSION OBJECTIVES
  3. 3. © 2017 PAREXEL INTERNATIONAL CORP. / 3 MARKET DYNAMICS ACCELERATING THE FOCUS ON PATIENT OUTCOMES Proliferation of data with shared value Convergence of health care industry and pharma around patient outcomes 21st Century Cures Act, PDUFA VI, EMA Guidance 2018 have time commitments Dependency on common data models and manual curation of data are reducing 10-20% improvement in patient outcomes have been reported by healthcare providers through use of big data Top 10 drug launch failures due to value gaps cost industry $12B Legislation Technology advances available to life science Volume to Value Shift
  4. 4. © 2017 PAREXEL INTERNATIONAL CORP. / 4 • Proliferation of data • Changes in the environment are permitting true access to the data and improved utility • Evolving regulatory positions on RWD • Recognition of data value by data owners • Technology – advances in data stores, analytics and visualization • Moves toward data standards • Heterogeneous data – including free text + lack of standards • The 3 “I’s”: incompleteness, inconsistency and inaccuracy • Data ownership and data-use agreement status • Data privacy / patient-level authorization • Lack of standard unique patient identifiers to enable linking • The need for re-identification of data • Data are rarely present in one, single data source – requires data aggregation from multiple sources DYNAMICS OF REAL WORLD DATA IN DETERMINING PATIENT OUTCOMES
  5. 5. © 2017 PAREXEL INTERNATIONAL CORP. / 5 VALUE OF REAL WORLD DATA – DRUG DEVELOPMENT VIEW • Health economic modeling • Market access strategy • Optimizing operational models and protocols for studies • Informing corporate and product development strategies TRADITIONAL USE CASES • Hybrid data delivery models • Randomized studies within EMR systems • Direct-with-patient study designs • Mobile health device-based studies EMERGING USE CASES Identify the Outcomes (Endpoints) Measure the Outcomes (Endpoints)
  6. 6. © 2017 PAREXEL INTERNATIONAL CORP. / 6 REAL WORLD RESEARCH STUDY MODELS PRAGMATIC ‘SPECTRUM’ Primary Interventional Studies Chart Abstraction Secondary Database Analyses EMR Data Analysis Primary NIS / Observational Studies / Registries Hybrid Studies Interventional Observational Minimally Interventional Studies Today’s field of play
  7. 7. © 2017 PAREXEL INTERNATIONAL CORP. / 7 THE CURRENT STATUS OF THE EMERGING USE CASES LOW BARRIERS TO USE • Multi-system or country studies • Data of interest in narratives / notes requiring NLP • Patient-authorized access to data HIGHER BARRIERS TO USE • Single country studies • Significant amount of key data in structured fields • Intended use of results can tolerate probabilistic matching of data LOW BARRIERS TO USE
  8. 8. © 2017 PAREXEL INTERNATIONAL CORP. / 8 By carefully managing which data elements are collected via SDA vs. EDC, hybrid studies can provide a better approach to research HYBRID DATA DELIVERY APPROACHES OFFER THE POTENTIAL TO OVERCOME CRITICAL EVIDENCE-GENERATION ISSUES Research challenges Site-based data collection (via EDC) for bulk of study data is expensive EMR/claims data are intended for non-research purposes and can lack consistency or particular data of interest Patient recruitment timelines are challenging to predict Hybrid solutions EMR/claims can be less expensive (at scale) with access to some types of health care data that is difficult to collect via EDC or PRO Use site-based data collection via EDC to target select data points where consistency/existence is critical to the study Improve predictability/speed by selecting sites with high volumes of eligible patients
  9. 9. © 2017 PAREXEL INTERNATIONAL CORP. / 9 HYBRID DATA DELIVERY MODELS CAN MAXIMIZE ROI RWE Platform Pharma Medical Affairs & Commercial Stakeholder Insights Payers Clinicians & Patients Regulators Ph 2/3/4+ SDA PRO & COA Genomics & Sensors & Real-time Data Access Integration of Multiple Data Streams Creation of Longitudinal Patient ViewsPhV Data Biomarkers Wearables Analytics Dashboard
  10. 10. © 2017 PAREXEL INTERNATIONAL CORP. / 10 MOBILE HEALTH DEVICE OUTCOMES A LOT TO CONSIDER BEYOND SELECTING THE DEVICE • Explicit cross functional discipline at PAREXEL • Led from PAREXEL® Informatics technology business unit • Supported by operational expertise from PAREXEL’s late stage business Review Process & Analytical Methods Data Context Evolving Regulatory Environment Data Volume CostData Validity Data Privacy and Ownership Technology Evaluation
  11. 11. © 2017 PAREXEL INTERNATIONAL CORP. / 11 RWD STRATEGY IN AN EVOLVING REGULATORY ENVIRONMENT Can’t be hung up on the common data model Push for “Qualified Data Sources” Regulatory Positions: EMA appears focused on structure FDA appears focused on use cases FDA is looking toward: 1) Randomization within EMR 2) Rare disease 3) Label expansions 4) Pediatric data Open the Dialogue FDA Mailbox: CDERMedicalPolicy- RealWorldEvidence @fda.hhs.gov
  12. 12. © 2017 PAREXEL INTERNATIONAL CORP. / 12 PATIENT PRIVACY PROTECTION AND AUTHORIZATION TO USE PERSONAL HEALTH INFORMATION Today’s Environment • Applicable privacy regulations for patient consent and patient authorization generally depends on: − Geography − Type of research organization − Sources of research funding − Types of real world data sources • Patient authorization and IRB approval to collect/utilize patient identifiers to link data link are typically required • Useful patient identity management tactics include: − Hashing − Tokens − Trusted third-parties Rules and regulations are to protect patients and research participants, not to prevent legitimate research. While the requirements may seem daunting, they are not insurmountable barriers to research. Near term progress to be made through increasing opt-In consenting *Registries for Evaluating Patient Outcomes: A User's Guide. 3rd edition. Agency for Healthcare Research and Quality (US); April 2014.
  13. 13. © 2017 PAREXEL INTERNATIONAL CORP. / 13 Aligning on Patient Outcomes • Endpoint selection needs to include patient outcomes that matter to patients, payers and define treatment value • Leverage the environmental forces to develop industry standard approaches • Solutions and capabilities will be developed incrementally – investments must be made, but with flexibility in delivery in mind IN CONCLUSION
  14. 14. © 2017 PAREXEL INTERNATIONAL CORP. / 14 THANK YOU © 2017 PAREXEL INTERNATIONAL CORP. / 14 FOR MORE INFORMATION: Access@PAREXEL.com www.PAREXEL.com/evidence-wisely

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