Date: Friday 19th November 2021
Time: 15:00-16:30 GMT
Speakers: Paul Dorinsky (AstraZeneca) and David Wright (AstraZeneca)
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians, referees and editors of medical journals.
What is the benefit of attending? Gain alignment on the clinical question(s) of interest; frame clinical questions which may be of interest to different stakeholders; be transparent when communicating trial results.
Building on the previous webinar 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 stakeholders. The background and disease context of the case will be described, the important events (termed intercurrent events) occurring in the trial will be described and three estimands will be showcased. It will then be explored how best to communicate the estimands in medical journals.
Topics of discussion will be raised at different points during 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 should be communicated in medical journals and how to encourage their inclusion in journal articles are particularly encouraged.
To view the flyer for this webinar, please click here.
You can now register for this event. This event is free of charge to both Members and Non Members of PSI.
To register your place, please click here.
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Speaker |
Biography |
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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 and Respiratory Medicine development. Dr. Dorinsky completed his undergraduate and medical training at the Ohio State University in Columbus, Ohio (USA). He received his undergraduate degree in mathematics in 1974 and his MD 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 University in 1983 and remained in that position until 1998. He was director of the Medical Intensive care unit and published extensively on the subjects of sepsis, ARDS and multiple organ failure. He served as President of the Ohio Thoracic Society for 2 years. He also served as chairman of the Critical Care Assembly of the American Thoracic Society and was on the Board of American Thoracic Society for 2 years. He received funding from the American Lung Association, the American Heart Association and the NIH. He was also awarded an Edward Livingston Trudeau Fellowship award from the American Lung Association. Dr. Dorinsky has been involved in Respiratory clinical development for over 20 years. He joined Pearl/AstraZeneca in 2016 and led the clinical development program for Breztri and is currently the Global Clinical Head of the Aerosphere franchise. |
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David Wright has been Head of Statistical Innovation at AstraZeneca since 2016 where he leads a group of experts in trial design and analysis of late phase clinical trials. Dr Wright received his BSc in Mathematics from the University of Leicester in 1989 and an MSc in Medical Statistics also from the University of Leicester in 1990. In 1995 Dr Wright received a PhD in Statistics from Queen Mary and Westfield College, 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 worked at the Medicines and Healthcare products Regulatory Agency (MHRA (formerly the Medicines Control Agency (MCA) initially as a Statistical Assessor. 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 Medicines Agency (EMA). Dr Wright took the lead in revising the CHMP guideline on Missing Data in Confirmatory Clinical Trials in 2011 and is currently focused on the recent developments in the field of Estimands and the ramifications of the Addendum to ICH E9 on Estimands. |
