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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.