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Project ScopeThe increasing interest/pressure to including results based on Real World Data as part of regulated clinical trial submissions and similar research initiatives is testing how current regulatory and good practice requirements can incorporate these results into submissions. Whilst specific projects have successfully addressed these issues, RWE guidelines or points for consideration are not yet formalised. PHUSE members are centrally involved in the management and analysis of these data, and best practice guidance for dealing with RWE data would assist members in this space. The project has three goals: 1: Establish a PHUSE project to focus on RWE issues. 2: Develop a White Paper presentation focused on establishing the range of areas that need to be considered/impact on the use of RWE in support of regulated clinical trial submissions. This would be focused on identifying issues such as data sources, RWE technologies, data privacy and related issues, standards etc. impacting on RWE use. (e.g. see PHUSE SDE London May 2019 presentations). 3: Identify and prioritise future RWE projects/sub-projects |
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Project Leads | Email |
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David Hood Sangeeta Bhattacharya Wendy Dobson | |
Project Members | Company |
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Adam Reich | IQVIA |
Andy Steen | EDJAnalytics |
Anil Sekhari | Sekharico Informatics |
Aldir Medeiros Filho | Industry |
Berber Snoeijer | Clinline |
Bhanu Kannan | FDA |
CHARAN KUMAR | Ephicacy |
Claudi Jimenez | Syneos Health |
Corey Young | EDJAnalytics |
Diego Saldana | Roche |
Elizabeth Merrall | S-Cubed |
Hao Chen | Pfizer |
Jeff Abolafia | Pinnacle21 |
Jingwen Zhang | Industry |
Kiichiro Toyoizumi | Shionogi |
Lisa Kang | Pharma Essentia |
Lisa Lin | FDA |
Marko Zivkovic | Genesis |
Michael Martinec | Roche |
Project Members | Company |
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Nicole Thorne | JNJ |
Nurcan Coskun | Industry |
Oluseun Shittu | GlaxoSmithKline |
Paul Murray | SAS |
Pranab Mitra | Merck |
Rachel Bowman | Loxley Analytics |
Rosa Bianca Gallo | The Hyve |
Scott Bahlavooni | Industry |
Siddharth Arthi | Zifornd |
Susan Eaton | Biogen |
Susan Olson | EDJAnalytics |
Susheel Arkala | MMS Holdings |
Shaojun Song | Yitu Technology |
Trisha Simpson | UCB |
Yixun Wu | Syneoshealth |
Ingeborg Holt | IMB |
Sadchla Mascary | Pfizer |
Swapna Kaveti | Industry |