Late Phase Outsourcing - Clinical Studies

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Best practices and considerations for conduct of Late Phase Studies.

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  • Jefferies April 2013
  • Late Phase Outsourcing - Clinical Studies

    1. 1. FOCUSED. TRUSTED. GLOBAL.Planning and Executing a LatePhase Trial: Setting Expectationsand Maximizing OutcomesAlexander Artyomenko MD PhD3rd Annual Outsourcing in Clinical Trials EuropeZurich, 14 May 2013
    2. 2. FOCUSED. TRUSTED. GLOBAL.o Key objectives and criticaldifferences of Late Phase researcho Early planning: maximizingproduct potentialo Selecting a strategic partner:benefits and considerations
    3. 3. FOCUSED. TRUSTED. GLOBAL.Example definitionsLate Phase Studieso Any study conducted on a marketed, fully approvedproducto Studies capturing clinical data and addressing real worldissues of safety, effectiveness, health outcomes,reimbursement and risk management
    4. 4. FOCUSED. TRUSTED. GLOBAL.Late Phase Research Objectiveso Long-term real-world safety data and riskmanagement FDA/EMA mandated Adverse claims New endpoints, health outcomes, effectivenesso Maximize market penetration New comparators and dosage forms Label extensiono Provide access to yet unregistered drugs EAP/Named Patient/Compassionate use studieso Health economics and Patient Reported Outcomes Reimbursement
    5. 5. FOCUSED. TRUSTED. GLOBAL.Interventional/Non-interventionalLate Phase Study Typeso Randomized Clinical Trialso Observational epidemiologic studieso Expanded Access Programso Post-Authorization Safety/Efficacy studieso Health Economics and Patient-Reported Outcomeso Product and disease registries
    6. 6. FOCUSED. TRUSTED. GLOBAL.Regulatory Frameworko GCP and GPPo ISPE Guidelines for GPPo CIOMS International Ethical Guidelines for EpidemiologicalStudieso Eudralex Volume 9A: Guidelines on Pharmacovigilance forMedicinal Products for Human Useo GRACE Principleso Country-specific HEOR guidelineso No harmonized legal framework across countries due to alower risk to subjectso High emphasis on scientific credibility and data protection
    7. 7. FOCUSED. TRUSTED. GLOBAL.Phase II/III vs. Late Phaseo Objectiveso Protocol designo Study Populationo Sites outreacho Data collectiono Regulatory documents and submissionso Site agreementso Monitoring
    8. 8. FOCUSED. TRUSTED. GLOBAL.Late Phase Studies/Non-interventionalo Capture real-world data/standard of careo Analyse data from a large number of patientso Less per patient costs than in a clinical trialo Increase disease and/or drug awarenesso Hypotheses generation and academicresearch supporto Create and support stakeholder relationships
    9. 9. FOCUSED. TRUSTED. GLOBAL.ChallengesLate Phase Studies/Non-interventionalo Attributing causality to outcomeso Retrospective and prospective datacollectiono Diversity of regulation, standards of careand cultures
    10. 10. MaximizingProduct Potential
    11. 11. FOCUSED. TRUSTED. GLOBAL.Early Planning for Late Phase
    12. 12. FOCUSED. TRUSTED. GLOBAL.Clinical to Commercialo Know the Stakeholderso Research unmet needso Understand diverse objectiveso Consider industry advances
    13. 13. FOCUSED. TRUSTED. GLOBAL.Engaging Broader Audienceo Phase I/II Safety vs. Long-term Safety Outcomeso Efficacy vs. Effectiveness Real-World Datao Cost and Value Compliance Health Economics
    14. 14. FOCUSED. TRUSTED. GLOBAL.Maximize Study Potentialo Focus on key objectives Impact on design, timelines, risks and costso Consider designs Follow-up extensions Health Economics and Patient-reported outcomes Genetic/biomarker testingo Target geographies Market access KOL support Product launch
    15. 15. FOCUSED. TRUSTED. GLOBAL.Starting Upo Feasibilityo Start-up timelineso Product approval statuso Submission requirementso Site communication and training
    16. 16. FOCUSED. TRUSTED. GLOBAL.Monitoringo Risk assessment duringprotocol developmento Focus on patient safety anddata qualityo Targeted on-site activitieso Timely data entryo Remote site managemento Patient recruitment…andretention!
    17. 17. FOCUSED. TRUSTED. GLOBAL.
    18. 18. FOCUSED. TRUSTED. GLOBAL.Data Managemento Electronic Data Captureo Electronic Health Recordso Direct Data Entry by patientso Multiple data sourceso Large data volumes
    19. 19. FOCUSED. TRUSTED. GLOBAL.Safety Reportingo Increased demand for real-world safety datao Focus on the events of special interest, SAEsand SUSARso Data mining beyond trials
    20. 20. FOCUSED. TRUSTED. GLOBAL.Selecting a Service Provider
    21. 21. FOCUSED. TRUSTED. GLOBAL.Selecting a Strategic Research Partnero Therapeutic expertiseo Local knowledge and global reacho Broad scope of serviceso Prior positive experienceo Operational expertise and efficiencieso Market access expertiseo Greater flexibility
    22. 22. FOCUSED. TRUSTED. GLOBAL.Continuous Collaborationo Facilitates early planningo Leverages previous learningo Ensures process clarityo Utilizes innovative technologieso Streamlines project executiono Maintains organizational focusSaves time and money!
    23. 23. FOCUSED. TRUSTED. GLOBAL.Late Phase Researcho Therapeutic, regulatory and operationalexpertise is essentialo Diverse objectives require early planningo Strategic partnership brings significantefficiencies to all stakeholders
    24. 24. Thank you!Dr Alexander Artyomenko MD PhDa.artyomenko@medpace.comwww.medpace.com

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