Real World Evidence

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Project Overview

The increasing interest/pressure to 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, RWE 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 for dealing with RWE data would assist members in this space. The project has three goals: 1: Establish a PHUSE project or WG to focus on RWE 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 in support of regulated clinical trial submissions. This would be focused on identifying issues such as data sources, RWE technologies, data privacy and related issues, standards etc. impacting on RWE use. (e.g. see PhUSE SDE London May 2019 presentations). 3: Identify and prioritise future RWE projects/sub-projects.

Project Leads

Name Role Organization E-mail
Andy Richardson Co-Lead Independent
David Hood Co-Lead Pfizer
Sangeeta Bhattacharya Co-Lead JNJ

Project Members

Name Organisation
Adam Reich IQVIA
Andy Steen
Anil Sekhari Sekharico Informatics
Aldir Medeiros Filho Industry
Berber Snoeijer Clinline
Bhanu Kannan FDA
Charan Kumar Ephicacy
Claudia Jimenez Syneos Health
Corey Young EdjAnalytics
Diego Saldana Roche
Elizabeth Merrall S-Cubed
Hao Chen Pfizer
Kiichiro Toyoizumi Shionogi
Lisa Kang Pharma Essentia
Lisa Lin FDA
Marko Zivkovic Genesis
Michael Martinec Roche
Nicole Thorne JNJ
Nurcan Coskun Industry
Oluseun Shittu GlaxoSmithKline
Paul Murray SAS
Pranab Mitra Merck
Rachel Bowman Loxley Analytics
Rosa Bianca Gallo The Hyve
Scott Bahlavooni Industry
Siddharth Arthi Zifornd
Susan Eaton Biogen
Susan Olson EdjAnalytics
Susheel Arkala MMS Holdings
Shaojun Song Yitu Technology
Trisha Simpson UCB
Yixun Wu Syneoshealth
Ingeborg Holt IBM
Sadchla Mascary Pfizer
Swapna Kaveti Industry
Jeff Abolafia Pinnacle 21

Project Activities

Project Updates

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Establish PHUSE RWE Project / WG Sep-2019
PHUSE Whitepaper/Presentation: Basic Considerations for the Use of RWE Data in Support of Regulated Clinical Trial Submissions Dec-2019
Consider and initiate RWE projects/sub-projects in identified areas for future consideration Dec-2019