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 (ClinLine) | b.snoeijer@clinline.eu |
David Hood (Pfizer) | |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
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 | Q2 2022 |
Community Forum: The Role of the Statistician and Statistical Programmer in Real-world Data Analysis. | Q3 2022 |
Community Forum: Challenges in Real World Data Ingestion and Standardization | Q4 2022 |
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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 |
Bree Newton | Evidera |
Charan Kumar | Ephicacy |
Claudi Jimenez | Syneos Health |
Corey Young | EDJ Analytics |
Devaki Thavarajah | Industry |
Diego Saldana | Roche |
Dishant Parikh | ICON DOCS |
Elizabeth Merrall | Janssen Research & Development |
Hao Chen | Pfizer |
Ingeborg Holt | IBM |
Jeff Abolafia | Pinnacle 21 |
Jingwen Zhang | Industry |
Kiichiro Toyoizumi | Shionogi |
Kipp Spanbauer | Gilead |
Lakshmi Mantha | Ephicacy |
Lisa Kang | PharmaEssentia |
Lisa Lin | FDA |
Marion Bonnet | Ipsen |
Marko Zivkovic | Genesis Research |
Mary Anne Rutkowski | Merck |
Maya Reimbaeva | Pfizer |
Michael Martinec | Roche |
Naga Dontamsetty | Takeda |
Project Members | Organisation |
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Nicole Thorne | Janssen Research & Development |
Nimita Limaye | IDC |
Nurcan Coskun | Industry |
Oluseun Shittu | GlaxoSmithKline |
Parag Shiralkar | Sumptuous Data Sciences |
Paul Murray | SAS Institute |
Pranab Mitra | Merck |
Rachel Bowman | Loxley Analytics |
Ramaiah Muvvala | Inductive Quotient |
Renping Zhang | Janssen Research & Development |
Ritesh Dhimmer | GSK |
Rosa Bianca Gallo | The Hyve |
Sadchla Mascary | Pfizer |
Sangeeta Bhattacharya | Janssen Research & Development |
Scott Bahlavooni | Nektar |
Shaojun Song | Yitu Technology |
Siddharth Arthi | Zifo RnD Solutions |
Sreekanth Reddy Yasa | IQVIA |
Stella Munuo | AstraZeneca |
Susan Eaton | Biogen |
Susan Olson | EDJ Analytics |
Susheel Arkala | MMS |
Swapna Kaveti | Industry |
Trisha Simpson | UCB |
Yixun WuSyneos Health | Syneos Health |