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Leveraging Imaging and Wearable Technology For Agile Clinical Trials

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Learn how to manage and overcome key challenges to deploying imaging and wearable technology effectively in clinical trials from PAREXEL Consulting experts.

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Leveraging Imaging and Wearable Technology For Agile Clinical Trials

  1. 1. © 2018 PAREXEL INTERNATIONAL CORP. LEVERAGING IMAGING AND WEARABLE TECHNOLOGY FOR AGILE TRIAL CONDUCT Dr. Peter Steiger, Vice President and Chief Scientific Officer, Patient Technology Solutions, PAREXEL Informatics April 17, 2018 PAREXEL KOREA SYMPOSIUM 2018
  2. 2. © 2018 PAREXEL INTERNATIONAL CORP. / 2 Feel Function Survive EFFICACY Adverse Events SAFETY Patient Technology ApprovalOutcome/Endpoint Real World Clinical Benefit EFFECTIVENESS
  3. 3. © 2018 PAREXEL INTERNATIONAL CORP. / 3 RIGHT ENDPOINT RECIST BLOOD PRESSURE PULSE OXIMETRY MAGNETIC RESONANCE IMAGING SPIROMETRY HALTER MONITORING CARDIAC OUTPUT MEASUREMENT
  4. 4. © 2018 PAREXEL INTERNATIONAL CORP. / 4 RIGHT QUESTION Effectiveness Efficacy Safety    • Drug Related Adverse Events? • Toxicity? • Therapeutic Window? • Progression Free Survival? • Cardiac Output Improved? • Joint Destruction Prevented? • Liver Fat Content Stabilized • Pulmonary Function Better? • Quality of Life Improved? • Real World Clinical Value? • Treatment Compliance? • Cost per QALY? • Existing Treatment Options? • Drug Interactions?
  5. 5. © 2018 PAREXEL INTERNATIONAL CORP. / 5 RIGHT TIME Data flood Now: Remote Past THE SITE LIMITED OUTCOME Outcome Driven  Technology Drivenx
  6. 6. © 2018 PAREXEL INTERNATIONAL CORP. / 6 THE TECHNOLOGY
  7. 7. © 2018 PAREXEL INTERNATIONAL CORP. / 7 NEXT GENERATION SENSORS PLATFORM COMPLEMENTED BY A PATIENT APP End-to-end Sensor-based Solution
  8. 8. © 2018 PAREXEL INTERNATIONAL CORP. / 8 End-to-End Accountability and Quality • Scientific and Medical Expertise • Technical Expertise (Imaging Modalities, Site Logistics) • Clinical Trial Supply Chain Management • Randomization Strategies (including adaptive trial designs) • Ability to accommodate complex study designs, response criteria and devices • Adaptable to changes in study design and technology • Ability to support both randomization and supply management • Compliant with local regulations • Technology Project Management • Flexibility (Phase, Region, Treatment Type, Technology, Sponsor) • Global Knowledge, Local Delivery • Scalability • Emergency code break KNOWLEDGE CASE STUDIES: IT TAKES MORE THAN TECHNOLOGY TECHNOLOGYPROCESS
  9. 9. © 2018 PAREXEL INTERNATIONAL CORP. / 9 CASE STUDY – WEARABLES SELF MEASUREMENT AND DIAGNOSIS IN GENERAL POPULATION Solution: • Leverage connected remote medical devices to facilitate secure, wireless transmission from home setting • Integrate IRT with device data to associate Subject IDs with device kits to ensure patient privacy • Integrate device data with EDC system to show in-clinic and remote device data side-by-side • Robust service management & supply strategy • End-to-end trial management solution Situation: • Sponsor required evidence to support switch from prescription drug to OTC • Regulatory requirement for general population self- diagnosis using remoted medical grade devices Challenges: • End-to-end solution required to collect, transmit, visualize data • Comparison of remote and in-clinic assessments • Blind Investigators to remote assessments
  10. 10. © 2018 PAREXEL INTERNATIONAL CORP. / 10 CASE STUDY – IMAGING FDA DRAFT GUIDANCE 2015 • Issued in March 2015 • Current standard for imaging in clinical trials • No direct EMA equivalent • Used as a standard for imaging in clinical trials globally • Incorporated feedback from imaging CRO industry organization PINTAD
  11. 11. © 2018 PAREXEL INTERNATIONAL CORP. / 11 CASE STUDY – IMAGING READER DISCREPANCY • Primary Reads – Investigator Reads versus Blinded Independent Central Review (BICR) – Single read vs Double read • Double read with Adjudication
  12. 12. © 2018 PAREXEL INTERNATIONAL CORP. / 12 CASE STUDY – IMAGING READER DISCREPANCY (CONT.) ADJUDICATION AND ADJUDICATION AGREEMENT RATE
  13. 13. © 2018 PAREXEL INTERNATIONAL CORP. / 13 CASE STUDY – IMAGING SUPPORT BREAKTHROUGH APPROVAL SCALABILITY Resourcing and infrastructure design DOCUMENTATION FLEXIBILITY COMMITMENT
  14. 14. © 2018 PAREXEL INTERNATIONAL CORP. / 14 Study began as a phase I n = 30 planned enrolled Read design single review 1 reader Reduced documentation Excel spreadsheet analysis Design of an advanced phase 3 n> 1200 Double-review with adjudication 10 high quality central readers (radiologists and oncologists) Full service model with full regulatory rigor Electronic analysis suite with customized enhancements including 3 criteria CASE STUDY – IMAGING SUPPORT BREAKTHROUGH APPROVAL (CONT.) Supported 2 FDA approvals 1 EMA approval Provision of images for preliminary clinical evidence for the designation + 1 FDA audit SCALABILITY
  15. 15. © 2018 PAREXEL INTERNATIONAL CORP. / 15 SUMMARY – TECHNOLOGY FOR AGILE TRIAL CONDUCT • Right question, right outcome, right time • Knowledge, process, technology • Flexibility, scalability, documentation, commitment
  16. 16. © 2018 PAREXEL INTERNATIONAL CORP. / 16 THANK YOU © 2018 PAREXEL INTERNATIONAL CORP. / 16

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