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, Real World Evidence 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 Real World Evidence data that 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 | |
Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
CURRENT STATUS Q22021 |
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Project status on plan, hosting a breakout session at CSS. |
Objectives & Deliverables | Timelines |
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White Paper which establishes a range of areas that need to be considered/impact the use of Real World Evidence. | Draft: July 2021 |
Published Deliverables | Date |
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 | Organisation |
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Adam Reich | IQVIA |
Andy Steen | EDJ Analytics |
Anil Sekhari | Sekharico |
Aldir Medeiros Filho | Industry |
Bhanu Kannan | FDA |
Charan Kumar | Ephicacy |
Claudi Jimenez | Syneos Health |
Corey Young | EDJ Analytics |
Devaki Thavarajah | Industry |
Diego Saldana | Roche |
Elizabeth Merrall | Janssen Vaccines |
Hao Chen | Pfizer |
Jeff Abolafia | Pinnacle 21 |
Jingwen Zhang | Industry |
Kiichiro Toyoizumi | Shionogi |
Lisa Kang | PharmaEssentia |
Lisa Lin | FDA |
Marion Bonnet | Ipsen |
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 | Nektar |
Siddharth Arthi | Zifo RnD Solutions |
Susan Eaton | Biogen |
Susan Olson | EDJ Analytics |
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 |
Kipp Spanbauer | Gilead |