Real World Evidence
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.
|Anil Sekhari||Sekharico Informatics|
|Aldir Medeiros Filho||Industry|
|Claudia Jimenez||Syneos Health|
|Lisa Kang||Pharma Essentia|
|Rachel Bowman||Loxley Analytics|
|Rosa Bianca Gallo||The Hyve|
|Susheel Arkala||MMS Holdings|
|Shaojun Song||Yitu Technology|
|Jeff Abolafia||Pinnacle 21|
Objectives and Timelines
List proposed project deliverables and timelines.
|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|