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/pressure to World RWE centrally practice guidance RWE 1: Establish a PHUSE project to focus on RWE issues. 2: RWE RWE RWE 3: 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

 
Sangeeta Bhattacharya 
Wendy Dobson (PHUSE Project Manager

(Axtria)

david

David.

hood@pfizer

Hood@Axtria.com

SBhatt11@its.jnj.com
Wendy@phuse.eu

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
Deliverables
Timelines
Consider and initiate RWE projects/sub-projects in identified areas for future consideration
Basic Considerations for the use of Real World Evidence (RWE) in Support of Regulated Clinical Trial Submissions: Version 1.0
,
16-Jul-2020
PublishedProject MembersCompanyAdam ReichIQVIAAndy SteenEDJAnalyticsAnil SekhariSekharico InformaticsAldir Medeiros FilhoIndustryBerber SnoeijerClinlineBhanu KannanFDACHARAN KUMAREphicacyClaudi JimenezSyneos HealthCorey YoungEDJAnalyticsDiego SaldanaRocheElizabeth MerrallS-CubedHao ChenPfizerJeff AbolafiaPinnacle21Jingwen ZhangIndustryKiichiro ToyoizumiShionogiLisa KangPharma EssentiaLisa LinFDAMarko ZivkovicGenesisMichael MartinecRocheProject MembersCompanyNicole ThorneJNJNurcan Coskun IndustryOluseun ShittuGlaxoSmithKlinePaul MurraySASPranab MitraMerckRachel BowmanLoxley AnalyticsRosa Bianca GalloThe HyveScott BahlavooniIndustrySiddharth ArthiZiforndSusan EatonBiogenSusan OlsonEDJAnalyticsSusheel ArkalaMMS HoldingsShaojun SongYitu TechnologyTrisha SimpsonUCBYixun WuSyneoshealthIngeborg HoltIMBSadchla MascaryPfizerSwapna KavetiIndustry