Participants
On 30th October 2023, IDERHA’s Work Package 6 held its first workshop with experts from regulatory authorities and HTA organizations.
Aims
The long-term goal of this work is to develop recommendations on criteria for determining the acceptability of real-world evidence (RWE) for key public health decision-making (i.e., regulatory and HTA). The first step towards this goal is a landscape review of the best practices and remaining gaps in current policies regarding the use of RWE. This workshop was convened to solicit expert input on landscape review and identify priority areas that require development to inform the future policy recommendations.
Key Findings
- Participants commented that the project goals and the landscape review are timely given the quickly evolving policy environment and expanding interest in the use of real-world evidence to support regulatory and HTA decision-making.
- Identifying areas of alignment across different policies and countries will help encourage efficiencies.
- Separate analysis may be required between regulatory and HTA documents, but it is also important to highlight where there is alignment and divergence between them where possible.
- Guidance for both pharmaceutical and medical devices should be considered with the consideration that there are likely to be differences.
- A range of topics were identified as potential gaps in current guidance that need of further exploration, including:
- Uncertainties with how to analyse and apply different types of emerging RWE (e.g. data from AI, patient wearables)
- Lack of trust and understanding of RWD and RWE undermining further adoption (e.g. cross-jurisdictional use and acceptability of RWE)
- Developing good study conduct practices around the collection and use of RWE (e.g., concerns of governance and transparency)
- If possible, continue to update the review over time to incorporate guidance that comes out across the span of the IDERHA project.
Please find the full workshop report here.