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Project Scope

The increasing interest in including

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The increasing interest/pressure to include

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:

  1. Focus on Real World Evidence issues.

  2. Develop a White Paper presentation focused on establishing the range of areas that need to be considered/impact on the use of

RWE

  1. Real World Evidence in support of regulated clinical trial submissions. This would be focused on identifying issues such as data sources, Real World Evidence technologies, data privacy and related issues, standards etc. impacting on Real World Evidence use. (e.g. see PHUSE SDE London May 2019 presentations).

  2. Identify and prioritise future Real World Evidence projects/sub-projects.



Project LeadsEmail
Berber Snoeijer (ClinLine)b.snoeijer@clinline.eu

David Hood

 
Sangeeta Bhattacharya  
david.hood@pfizer.com
SBhatt11@its.jnj.com

(Axtria)

David.Hood@Axtria.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global

​


Status
colourBlue
titleCurrent Status
Q3/4 2022



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 DeliverablesDate
Basic Considerations for the use of Real World Evidence (RWE) in Support of Regulated Clinical Trial Submissions: Version 1.016-Jul-2020