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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 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).

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

Project LeadsEmail

David Hood

Paula Rowley 

(PHUSE Project Assistant) 


Project status on plan, drafting a White Paper.

Objectives & Deliverables


White Paper which establishes a range of areas that need to be considered/impact the use of Real World Evidence.

Draft: July 2021
Project MembersOrganisation
Adam ReichIQVIA
Andy SteenEDJ Analytics
Anil SekhariSekharico 
Aldir Medeiros FilhoIndustry
Bhanu KannanFDA
Charan Kumar Ephicacy
Claudi JimenezSyneos Health
Corey YoungEDJ Analytics
Devaki ThavarajahIndustry
Diego SaldanaRoche
Elizabeth MerrallJanssen Research & Development
Hao ChenPfizer
Jeff AbolafiaPinnacle 21
Jingwen ZhangIndustry
Kiichiro ToyoizumiShionogi
Lisa KangPharmaEssentia
Lisa LinFDA
Marion BonnetIpsen
Marko ZivkovicGenesis Research
Michael MartinecRoche
Mary Anne RutkowskiMerck
Project MembersOrganisation
Kipp SpanbauerGilead
Nicole ThorneJanssen Research & Development
Nurcan Coskun Industry
Oluseun ShittuGlaxoSmithKline
Paul MurraySAS Institute
Pranab MitraMerck
Rachel BowmanLoxley Analytics
Rosa Bianca GalloThe Hyve
Scott BahlavooniNektar
Siddharth ArthiZifo RnD Solutions
Susan EatonBiogen
Susan OlsonEDJ Analytics
Susheel ArkalaMMS 
Shaojun SongYitu Technology
Trisha SimpsonUCB
Yixun WuSyneos Health
Ingeborg HoltIBM
Sadchla MascaryPfizer
Stella MunuoAstraZeneca
Swapna KavetiIndustry
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