Project Scope | ||||||||||||
The increasing interest | /pressure to in including results based on Real | World -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 Real World Evidence guidelines or points for consideration are not yet formalised. PHUSE members are | centrally involved in the management and analysis of these data, and best | practice guidance practices for dealing with | RWE Real World Evidence data that would assist members in this space. The project has three goals: | 1: Establish a PHUSE project to focus on RWE issues. 2:
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Project Leads | |
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Berber Snoeijer (ClinLine) | b.snoeijer@clinline.eu |
David Hood |
Sangeeta Bhattacharya
Wendy Dobson (PHUSE Project Manager(Axtria) |
SBhatt11@its.jnj.com
Wendy@phuse.eu
Deliverables
Timelines
Consider and initiate RWE projects/sub-projects in identified areas for future consideration
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
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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 |
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 |