Versions Compared

Old Version 24

changes.mady.by.user Wendy Dobson

Saved on

compared with

New Version Current

changes.mady.by.user Nicola Newton

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Image Modified


/pressure to World RWE centrally RWE Establish a PHUSE project to focus on RWE issues RWE RWE RWE RWE

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:

  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

  1. Real World Evidence in support of regulated clinical trial submissions. This would be focused on identifying issues such as data sources,

  1. Real World Evidence technologies, data privacy and related issues, standards etc. impacting on

  1. Real World Evidence use. (e.g. see PHUSE SDE London May 2019 presentations).

  2. Identify and prioritise future

  1. Real World Evidence projects/sub-projects.



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

David Hood (Axtria)

david

David.

hood@pfizer

Hood@Axtria.com

Wendy Dobson
Katie Warren (PHUSE Project
Manager
Assistant)
wendy@phuse
katie@phuse.global

​


Status
colourBlue
titleCurrent Status

Q42020Reviewed content that was captured at this years CSS, and have outline for a White Paper. Will be drafting New Project Requests by year end for approval by Industry Representatives.

Deliverables

Timelines

Consider and initiate RWE projects/sub-projects in identified areas for future consideration

Ongoing discussions

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: 

Published

Version 1.0
,
16-Jul-2020
Project MembersCompanyAdam ReichIQVIAAndy SteenEDJAnalyticsAnil SekhariSekharico InformaticsAldir Medeiros FilhoIndustryBhanu KannanFDACHARAN KUMAREphicacyClaudi JimenezSyneos HealthCorey YoungEDJAnalyticsDiego SaldanaRocheElizabeth MerrallS-cubedHao ChenPfizerJeff AbolafiaPinnacle 21Jingwen ZhangIndustryKiichiro ToyoizumiShionogiLisa KangPharma EssentiaLisa LinFDAMarko ZivkovicGenesisMichael MartinecRocheProject MembersCompanyNicole ThorneJanssen Research & DevelopmentNurcan Coskun IndustryOluseun ShittuGlaxoSmithKlinePaul MurraySASPranab MitraMerckRachel BowmanLoxley AnalyticsRosa Bianca GalloThe HyveScott BahlavooniIndustrySiddharth ArthiZiforndSusan EatonBiogenSusan OlsonEDJAnalyticsSusheel ArkalaMMS Shaojun SongYitu TechnologyTrisha SimpsonUCBYixun WuSyneos HealthIngeborg HoltIBMSadchla MascaryPfizerSwapna KavetiIndustry