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Project Scope The increasing interest in 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 involved in the management and analysis of these data, and best practices for dealing with RWE data would assist members in this space. The project has three goals: Establish a PHUSE project to focus on RWE issues. 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). Identify and prioritise future RWE projects/sub-projects.
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New Project for Phase II has been approved and the team have drafted an outline of the White Paper. Currently assigning project members to sections of the paper to curate. |
Objectives & Deliverables | Timelines |
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White Paper which establishes a range of areas that need to be considered/impact the use of RWE. | Draft: July 2021 |
Project Members | Organisation |
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Adam Reich | IQVIA |
Andy Steen | EDJAnalytics |
Anil Sekhari | Sekharico Informatics |
Aldir Medeiros Filho | Industry |
Bhanu Kannan | FDA |
Charan Kumar | Ephicacy |
Claudi Jimenez | Syneos Health |
Corey Young | EDJAnalytics |
Devaki Thavarajah | Industry |
Diego Saldana | Roche |
Elizabeth Merrall | S-cubed |
Hao Chen | Pfizer |
Jeff Abolafia | Pinnacle 21 |
Jingwen Zhang | Industry |
Kiichiro Toyoizumi | Shionogi |
Lisa Kang | Pharma Essentia |
Lisa Lin | FDA |
Marko Zivkovic | Genesis |
Michael Martinec | Roche |
Project Members | Organisation |
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Nicole Thorne | Janssen Research & Development |
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 |
Shaojun Song | Yitu Technology |
Trisha Simpson | UCB |
Yixun Wu | Syneos Health |
Ingeborg Holt | IBM |
Sadchla Mascary | Pfizer |
Stella Munuo | AstraZeneca |
Swapna Kaveti | Industry |