Project Scope | ||||||
The increasing interest in including results based on | real Real-world | data Data as part of regulated | Clinical Trial Submissions 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 Real World Evidence guidelines or points for consideration are not yet formalised | . This project aims to focus on the issues within Real World Evidence and develop a White Paper which establishes a . 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:
| RWE
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| Project Leads | |
|---|---|
| Berber Snoeijer (ClinLine) | b.snoeijer@clinline.eu |
David Hood |
Sangeeta Bhattacharya
david.hood@pfizer.com
(Axtria) |
| Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
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Objectives & Deliverables | Timelines |
|---|---|
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 |
| 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 |