The increasing interest/pressure to include 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. This project aims to focus on the issues within Real World Evidence and develop a White Paper which establishes a range of areas that need to be considered/impact the use of RWE in support of regulated clinical trial submissions |
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