BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: Friday 19th November 2021\nTime: 15:00-16:30 GMT\nSpeaker s: \;Paul Dorinsky (AstraZeneca) and David Wright (AstraZeneca)\n\nWho is this event intended for? \;Clinicians\, Regulators\, Investigators \, Academics\, members of Ethics Committees\, Statisticians\, referees and editors of medical journals.\nWhat is the benefit of attending? \;Gai n alignment on the clinical question(s) of interest\; frame clinical quest ions which may be of interest to different stakeholders\; be transparent w hen communicating trial results.\nOverview\nBuilding on the previous webin ar series we will present a refresher on the key elements of the estimand framework and use the ETHOS study to illustrate the estimand framework and to highlight the different options that may be of interest to different s takeholders. The background and disease context of the case will be descri bed\, the important events (termed intercurrent events) occurring in the t rial will be described and three estimands will be showcased. It will then be explored how best to communicate the estimands in medical journals.&nb sp\;  \;\n\nTopics of discussion will be raised at different points du ring the training and there will be time allowed (30 mins) to answer your questions\, which can be posted via the chat. Questions on how estimands s hould be communicated in medical journals and how to encourage their inclu sion in journal articles are particularly encouraged. \;\n\nTo view th e flyer for this webinar\, please click here.\nRegistration\nYou can now r egister for this event. This event is \;free of charge \;to both M embers and Non Members of PSI.\nTo register your place\, please click here .\nSpeaker Details\n\n\n\n \n \n \n Speake r\n \n \n Biography\n \n \n \n \n \n Paul Dorinsky\n \n \n Dr. Paul Dorinsky has over 35 years of experience in Academic Medicine and Medicine Development and has more than 90 per-reviewed publications in Respiratory and Critical Care Medicine an d Respiratory Medicine development. Dr. Dorinsky completed his undergradua te and medical training at the Ohio State University in Columbus\, Ohio (U SA). He received his undergraduate degree in mathematics in 1974 and his M D degree in 1978. He completed his Residency Training in Internal Medicine in 1981 and his Pulmonary and Critical Care Medicine training in 1983. He joined the Pulmonary and Critical Care Faculty of the Ohio State Universi ty in 1983 and remained in that position until 1998. He was director of th e Medical Intensive care unit and published extensively on the subjects of sepsis\, ARDS and multiple organ failure. He served as President of the O hio Thoracic Society for 2 years. He also served as chairman of the Critic al Care Assembly of the American Thoracic Society and was on the Board of American Thoracic Society for 2 years. He received funding from the Americ an Lung Association\, the American Heart Association and the NIH. He was a lso awarded an Edward Livingston Trudeau Fellowship award from the America n Lung Association. Dr. Dorinsky has been involved in Respiratory clinical development for over 20 years. He joined Pearl/AstraZeneca in 2016 and le d the clinical development program for Breztri and is currently the Global Clinical Head of the Aerosphere franchise.\n \n \n \n \n \n David Wright\n \n \n David Wright has been Head of Statistical Innovat ion at AstraZeneca since 2016 where he leads a group of experts in trial d esign and analysis of late phase clinical trials. Dr Wright received his B Sc in Mathematics from the University of Leicester in 1989 and an MSc in M edical Statistics also from the University of Leicester in 1990. In 1995 D r Wright received a PhD in Statistics from Queen Mary and Westfield Colleg e\, University of London. From 1994 to 1996 Dr Wright did a Post Doc at th e University of Warwick and he was a Lecturer in Medical Statistics at Uni versity College London from 1996 to 1999. From 1999 to 2016 Dr Wright work ed at the Medicines and Healthcare products Regulatory Agency (MHRA (forme rly the Medicines Control Agency (MCA) initially as a Statistical Assessor . From 2011 Dr Wright was an Expert Assessor and Deputy Unit Manager of th e Statistics and Pharmacokinetics Unit. From 2011 to 2016 Dr Wright was th e Chair of the Biostatistics Working Party (BSWP) at the European Medicine s Agency (EMA). Dr Wright took the lead in revising the CHMP guideline on Missing Data in Confirmatory Clinical Trials in 2011 and is currently focu sed on the recent developments in the field of Estimands and the ramificat ions of the Addendum to ICH E9 on Estimands.\n \n \n \n\n \; DTEND:20211119T163000Z DTSTAMP:20260913T051439Z DTSTART:20211119T150000Z LOCATION: SEQUENCE:0 SUMMARY:PSI EIWG Webinar: Estimands from trial planning to publication in m edical journals: The ETHOS trial UID:RFCALITEM639248732792035757 X-ALT-DESC;FMTTYPE=text/html:Date: Friday 19th November 20 21
\nTime: 15:00-16:30 GMT
\nSpeakers:< /strong> \;Paul Dorinsky (AstraZeneca) and David Wright (Astr aZeneca)
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\nWho is this event intended for?&n bsp\;Clinicians\, Regulators\, Investigators\, Academics\, members of Ethi cs Committees\, Statisticians\, referees and editors of medical journals.< br />\nWhat is the benefit of attending? \;Gain align ment on the clinical question(s) of interest\; frame clinical questions wh ich may be of interest to different stakeholders\; be transparent when com municating trial results.
\n

Overview

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Building on the pre vious webinar series we will present a refresher on the key elements of th e estimand framework and use the ETHOS study to illustrate the estimand fr amework and to highlight the different options that may be of interest to different stakeholders. The background and disease context of the case wil l be described\, the important events (termed intercurrent events) occurri ng in the trial will be described and three estimands will be showcased. I t will then be explored how best to communicate the estimands in medical j ournals. \;  \;
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\nTopics of discussion will be raised at different points during the training and there will be time allowed (3 0 mins) to answer your questions\, which can be posted via the chat. Quest ions on how estimands should be communicated in medical journals and how t o encourage their inclusion in journal articles are particularly encourage d. \;
\n
\nTo view the flyer for this webinar\, please click here< /a>.

\n

Registration

\n

You can now register for this event. This event is \;free of charge \;to both Members and Non M embers of PSI.
\nTo register your place\, please click here.

\n

Speaker Details

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Speaker

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Bi ography

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Pauledit
\n Paul Dorinsky

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Dr. Paul Dorinsky has over 35 years of experience in Acad emic Medicine and Medicine Development and has more than 90 per-reviewed p ublications in Respiratory and Critical Care Medicine and Respiratory Medi cine development. Dr. Dorinsky completed his undergraduate and medical tra ining at the Ohio State University in Columbus\, Ohio (USA). He received h is undergraduate degree in mathematics in 1974 and his MD degree in 1978. He completed his Residency Training in Internal Medicine in 1981 and his P ulmonary and Critical Care Medicine training in 1983. He joined the Pulmon ary and Critical Care Faculty of the Ohio State University in 1983 and rem ained in that position until 1998. He was director of the Medical Intensiv e care unit and published extensively on the subjects of sepsis\, ARDS and multiple organ failure. He served as President of the Ohio Thoracic Socie ty for 2 years. He also served as chairman of the Critical Care Assembly o f the American Thoracic Society and was on the Board of American Thoracic Society for 2 years. He received funding from the American Lung Associatio n\, the American Heart Association and the NIH. He was also awarded an Edw ard Livingston Trudeau Fellowship award from the American Lung Association . Dr. Dorinsky has been involved in Respiratory clinical development for o ver 20 years. He joined Pearl/AstraZeneca in 2016 and led the clinical dev elopment program for Breztri and is currently the Global Clinical Head of the Aerosphere franchise.

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Davidedit
\n Davi d Wright

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David Wright has been Head of Statistical Inno vation at AstraZeneca since 2016 where he leads a group of experts in tria l design and analysis of late phase clinical trials. Dr Wright received hi s BSc in Mathematics from the University of Leicester in 1989 and an MSc i n Medical Statistics also from the University of Leicester in 1990. In 199 5 Dr Wright received a PhD in Statistics from Queen Mary and Westfield Col lege\, University of London. From 1994 to 1996 Dr Wright did a Post Doc at the University of Warwick and he was a Lecturer in Medical Statistics at University College London from 1996 to 1999. From 1999 to 2016 Dr Wright w orked at the Medicines and Healthcare products Regulatory Agency (MHRA (fo rmerly the Medicines Control Agency (MCA) initially as a Statistical Asses sor. From 2011 Dr Wright was an Expert Assessor and Deputy Unit Manager of the Statistics and Pharmacokinetics Unit. From 2011 to 2016 Dr Wright was the Chair of the Biostatistics Working Party (BSWP) at the European Medic ines Agency (EMA). Dr Wright took the lead in revising the CHMP guideline on Missing Data in Confirmatory Clinical Trials in 2011 and is currently f ocused on the recent developments in the field of Estimands and the ramifi cations of the Addendum to ICH E9 on Estimands.

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