Early stakeholder interaction and advice on RWD and RWE: a scoping review

Study type

• Study topic:
  Other
• Study type:
  Not applicable
• Scope of the study:
  Scoping review (including literature review)
• Data collection methods:
  Secondary use of data

Study design details

• Study design:
  Scoping reviews are a fast-growing evidence synthesis approach for providing an overview across a variety of fields, so their main purpose is usually to describe and map a body of literature in terms of general characteristics.
• Main study objective:
  This study aims to analyse the content and focus of stakeholder requests, along with the corresponding advice or outcomes provided by EMA during early interactions related to RWD and RWE, by reviewing EMA documents over the past five years (2020–2025).