late phase outsourcing - clinical studies
DESCRIPTION
Best practices and considerations for conduct of Late Phase Studies.TRANSCRIPT
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Planning and Executing a Late Phase Trial: Setting Expectations and Maximizing Outcomes
Alexander Artyomenko MD PhD3rd Annual Outsourcing in Clinical Trials Europe
Zurich, 14 May 2013
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o Key objectives and critical
differences of Late Phase
research
o Early planning: maximizing
product potential
o Selecting a strategic partner:
benefits and considerations
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Example definitions Late Phase Studies
o Any study conducted on a marketed, fully approved
product
o Studies capturing clinical data and addressing real
world issues of safety, effectiveness, health outcomes,
reimbursement and risk management
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Late Phase Research Objectives
o Long-term real-world safety data and risk management FDA/EMA mandated Adverse claims New endpoints, health outcomes, effectiveness
o Maximize market penetration New comparators and dosage forms Label extension
o Provide access to yet unregistered drugs EAP/Named Patient/Compassionate use studies
o Health economics and Patient Reported Outcomes Reimbursement
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Interventional/Non-interventionalLate Phase Study Types
o Randomized Clinical Trials
o Observational epidemiologic studies
o Expanded Access Programs
o Post-Authorization Safety/Efficacy studies
o Health Economics and Patient-Reported
Outcomes
o Product and disease registries
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Regulatory Frameworko GCP and GPPo ISPE Guidelines for GPPo CIOMS International Ethical Guidelines for Epidemiological
Studieso Eudralex Volume 9A: Guidelines on Pharmacovigilance for
Medicinal Products for Human Useo GRACE Principleso Country-specific HEOR guidelines
o No harmonized legal framework across countries due to a lower risk to subjects
o High emphasis on scientific credibility and data protection
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Phase II/III vs. Late Phase
o Objectiveso Protocol designo Study Populationo Sites outreacho Data collectiono Regulatory documents and submissionso Site agreementso Monitoring
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Late Phase Studies/Non-interventional
o 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 academic
research supporto Create and support stakeholder relationships
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ChallengesLate Phase Studies/Non-interventional
o Attributing causality to outcomeso Retrospective and prospective data
collectiono Diversity of regulation, standards of care
and cultures
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Maximizing Product Potential
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Early Planning for Late Phase
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Clinical to Commercial
o Know the Stakeholderso Research unmet needso Understand diverse objectiveso Consider industry advances
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Engaging Broader Audience
o Phase I/II Safety vs. Long-term Safety Outcomes
o Efficacy vs. Effectiveness Real-World Data
o Cost and Value Compliance Health Economics
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Maximize Study Potential
o Focus on key objectives Impact on design, timelines, risks and costs
o Consider designs Follow-up extensions Health Economics and Patient-reported outcomes Genetic/biomarker testing
o Target geographies Market access KOL support Product launch
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Starting Up
o Feasibilityo Start-up timelineso Product approval statuso Submission requirementso Site communication and training
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Monitoring
o Risk assessment during protocol development
o Focus on patient safety and data quality
o Targeted on-site activitieso Timely data entryo Remote site managemento Patient recruitment…and
retention!
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Data Management
o Electronic Data Captureo Electronic Health Recordso Direct Data Entry by patientso Multiple data sourceso Large data volumes
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Safety Reporting
o Increased demand for real-world safety datao Focus on the events of special interest, SAEs
and SUSARs o Data mining beyond trials
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Selecting a Service Provider
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Selecting a Strategic Research Partner
o Therapeutic expertiseo Local knowledge and global reacho Broad scope of serviceso Prior positive experienceo Operational expertise and efficiencieso Market access expertiseo Greater flexibility
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Continuous Collaboration
o Facilitates early planningo Leverages previous learning o Ensures process clarityo Utilizes innovative technologieso Streamlines project executiono Maintains organizational focus
Saves time and money!
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Late Phase Research
o Therapeutic, regulatory and operational
expertise is essential
o Diverse objectives require early planning
o Strategic partnership brings significant
efficiencies to all stakeholders