Project ScopeThe 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:
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Project Leads | |
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Berber Snoeijer | b.snoeijer@clinline.eu |
David Hood | |
Wendy Dobson (PHUSE Project Manager) |
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Reviewed content that was captured at this years CSS, and have outline for a White Paper. Will be drafting New Project Requests by year end for approval by Industry Representatives. |
Deliverables | Timelines |
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Consider and initiate RWE projects/sub-projects in identified areas for future consideration | Ongoing discussions |
Basic Considerations for the use of Real World Evidence (RWE) in Support of Regulated Clinical Trial Submissions: | Version 1.0, 16-Jul-2020 |
Project Members | Company |
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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 |
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 | Company |
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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 |
Swapna Kaveti | Industry |