Collaborating with a wide range of stakeholders in medicines development to assess the acceptability and usefulness of Real World Evidence (RWE) and approaches to the analyses of RWE, for the purpose of estimating the effectiveness of new medicines
Healthcare decision makers need to make decisions on the best available estimates of the safety and effectiveness of new medicines; pharmaceutical R&D need to make decisions on the best medicine development programmes that provide these estimates
The overal aim of WP1 is to develop a common understanding amongst healthcare decision makers and pharmaceutical R&D of the acceptability and usefulness of innovative development programmes which use RWE to estimate the effectiveness of new medicines.
The key activities of WP1 are:
- Via five case studies in disease areas where challenges have been encountered in estimating effectiveness, test the acceptability and usefulness of innovative medicine development programmes which generate or make use of RWE and consolidate best practice in various stages of the medicine development process relating to the generation and use of RWE.
- Identify relevant stakeholders and examine evidence from relevant initiatives to give an overview of current perspectives and policies around early use of RWE.
- Develop a glossary to promote a common understanding of terms used in discussion of RWE.
The main output of WP1 will be a decision-making framework to support healthcare decision makers and pharmaceutical R&D, consisting of guidance on major RWE issues supported by examples from case studies. The guidance will help decision-makers to assess the acceptability and usefulness of innovative development programmes and analyses that include RWE.