BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:GMT Standard Time BEGIN:STANDARD DTSTART:20251002T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=10 TZNAME:GMT Standard Time TZOFFSETFROM:+0100 TZOFFSETTO:+0000 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T010000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=1;BYMINUTE=0;BYMONTH=3 TZNAME:GMT Daylight Time TZOFFSETFROM:+0000 TZOFFSETTO:+0100 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Time: 14:00 - 15:30 UK Time\nPresenters: Kim Cocks \;(Adelp hi Values)\, Andrew Thompson (EMA) and Christoph Gerlinger (Bayer)\n\nClin ical Trials are increasingly featuring a wide variety of Patient Reported Outcomes (PROs). \; PROs are important endpoints to both regulatory an d health technology bodies in their assessments and approvals. There are s tandard ways in which PRO instruments are developed and validated\, as wel l as important concepts for designing and interpretation of PRO data in cl inical trials such as assessing the Minimally Clinically Important Differe nces (MCIDs/MIDs) and the use of a Responder definition. \nThe intent of t his webinar is to describe an overview of how PROs tools are developed and used in clinical trial settings and how results can be clinically and mea ningfully interpreted. In addition\, a regulatory viewpoint will be shared on the key considerations for PROs. The talks will also include examples and case-studies showing the derivation of a validated thresholds for trea tment responder and interpretation of PROs in the context of regulatory ap proval.\nClick here \;to view the flyer. \;\n\nKim Cocks (Adelphi Values)\nKim Cocks is a Director and Principal Statistician at Adelphi Val ues\, a global healthcare consultancy. She has worked as a medical statist ician and clinical trial methodologist for over 20 years across pharmaceut ical\, academic and consultancy environments. She specialises in PRO inter pretation and analysis and is an active member of both the EORTC Quality o f Life group and ISOQOL.\n\n\n\n\n\nAbstract\nOverview of PROs and clinica lly meaningful interpretation\n\nPROs are validated instruments designed t o provide a direct report from the patient on aspects of their health incl uding symptoms and functioning. This talk will provide a brief overview of how PROs are developed\, how they provide a score for multi-dimensional a spects of a patient&rsquo\;s health and why these can be difficult to inte rpret. The variety of quantitative and qualitative methods available to ai d interpretation will be introduced.  \;\n\n\nAndrew Thomson (EMA)\n\n Andrew Thomson is a statistician at the EMA\, in the Human Medicines Resea rch &\; Development Support \; Division. Prior to joining the EMA i n 2014\, he spent 7 years at the MHRA\, initially as a Statistical Assesso r in the Licensing Division\, and subsequently Head of Epidemiology in the Vigilance &\; Risk Management of Medicines Division.\n\n\n\n\n\n\n\n\n Abstract\nRegulatory Considerations for PROs\nIn this talk I will present some regulatory considerations on the use of PROs in regulatory assessment \, and how they can be developed. These will be discussed alongside a rece nt case example that has been through the qualification procedure at EMA.\ n\n\n\nChristoph Gerlinger (Bayer)\n\nChristoph Gerlinger is Bayer&rsquo\; s Expert Statistician for Health Technology Assessment and Women&rsquo\;s Health. He is the regulatory chair of the European Federation of Statistic ians in the Pharmaceutical Industry (EFSPI) and a work package leader for the IMI BigData@Heart project. Christoph worked as statistician over 25 ye ars in the pharmaceutical industry and in his spare time he teaches at the University Medical School of Saarland.\n\n\n\n\n\nAbstract\nEmpirical der ivation of the minimal important difference for PROs\nIn this talk I will present some methods on how to derive the minimal important difference for PROs from a clinical trial. I will present a worked example where we used this empirical minimal important difference to formulate a responder defi nition that was then accepted by the FDA.\n\n\n \n \n  \;Registration\n \n \n  \;PSI Member\n Free \;\n \n \n  \;Non-member\ n £\;20 (plus VAT) \; \;\n \n \n\n\nTo a ccess the recording\, please visit the Video-on-Demand Library. DTEND:20180508T143000Z DTSTAMP:20261009T113449Z DTSTART:20180508T130000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Webinar: Patient Reported Outcomes (PROs) - Clinically Meaningf ul Interpretation UID:RFCALITEM639271424897556774 X-ALT-DESC;FMTTYPE=text/html:Time: 14:00 - 15:30 UK Time\nPresenters: Kim Cocks \;(Adelphi Values)\, Andr ew Thompson (EMA) and Christoph Gerlinger (Bayer)
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Clinical Trials are increasingly featuring a wide variety of Patient Reported Outcomes (PROs). \; PROs are important endpoints to both reg ulatory and health technology bodies in their assessments and approvals. T here are standard ways in which PRO instruments are developed and validate d\, as well as important concepts for designing and interpretation of PRO data in clinical trials such as assessing the Minimally Clinically Importa nt Differences (MCIDs/MIDs) and the use of a Responder definition.

\n< p>The intent of this webinar is to describe an overview of how PROs tools are developed and used in clinical trial settings and how results can be c linically and meaningfully interpreted. In addition\, a regulatory viewpoi nt will be shared on the key considerations for PROs. The talks will also include examples and case-studies showing the derivation of a validated th resholds for treatment responder and interpretation of PROs in the context of regulatory approval.

\nClick here \;to view the flyer. \;
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Kim Cocks (Adelphi Values)

\nkim cocksKim Cocks is a Director and Principal Statistician at Adelphi Va lues\, a global healthcare consultancy. She has worked as a medical statis tician and clinical trial methodologist for over 20 years across pharmaceu tical\, academic and consultancy environments. She specialises in PRO inte rpretation and analysis and is an active member of both the EORTC Quality of Life group and ISOQOL.
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\n< br />\nAbstract
\nOverview of PROs and clinically meaningful inte rpretation
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PROs are validated instruments de signed to provide a direct report from the patient on aspects of their hea lth including symptoms and functioning. This talk will provide a brief ove rview of how PROs are developed\, how they provide a score for multi-dimen sional aspects of a patient&rsquo\;s health and why these can be difficult to interpret. The variety of quantitative and qualitative methods availab le to aid interpretation will be introduced.  \;

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Andrew Thomson (EMA)
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\nAndrew Thomson is a st atistician at the EMA\, in the Human Medicines Research &\; Development Support \; Division. Prior to joining the EMA in 2014\, he spent 7 ye ars at the MHRA\, initially as a Statistical Assessor in the Licensing Div ision\, and subsequently Head of Epidemiology in the Vigilance &\; Risk Management of Medicines Division.
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\nAbstract
\n< em>Regulatory Considerations for PROs
\nIn this tal k I will present some regulatory considerations on the use of PROs in regu latory assessment\, and how they can be developed. These will be discussed alongside a recent case example that has been through the qualification p rocedure at EMA.
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Christoph Ge rlinger (Bayer)
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\nchristoph geringerChristoph Gerlinger is Bayer&rsquo\;s Exp ert Statistician for Health Technology Assessment and Women&rsquo\;s Healt h. He is the regulatory chair of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and a work package leader for the I MI BigData@Heart project. Christoph worked as statistician over 25 years i n the pharmaceutical industry and in his spare time he teaches at the Univ ersity Medical School of Saarland.
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\nAbstract
\nEmpirical derivation of the minimal im portant difference for PROs
\nIn this talk I will p resent some methods on how to derive the minimal important difference for PROs from a clinical trial. I will present a worked example where we used this empirical minimal important difference to formulate a responder defin ition that was then accepted by the FDA.

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 \;Registration
 \;PSI MemberFree \;
 \;Non-member£\;20 (plus VAT) \; \;
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To access the recording\, please visit the Video-o n-Demand Library.
END:VEVENT END:VCALENDAR