Quantify Research recently joined regulators and industry in the EMA’s Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use.
𝐌𝐚𝐧𝐲 𝐝𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧𝐬 𝐟𝐨𝐜𝐮𝐬𝐞𝐝 𝐨𝐧 𝐰𝐡𝐚𝐭 𝐜𝐨𝐧𝐬𝐭𝐢𝐭𝐮𝐭𝐞𝐬 𝐝𝐚𝐭𝐚 𝐪𝐮𝐚𝐥𝐢𝐭𝐲. 𝐓𝐡𝐞𝐬𝐞 𝐢𝐧𝐜𝐥𝐮𝐝𝐞 𝐝𝐚𝐭𝐚 𝐭𝐡𝐚𝐭 𝐚𝐫𝐞:
⭐ Foundational: What is the process of generating, collecting and making available data together with the documentation of these steps?
⭐ Intrinsic: What can be derived from the dataset and how can these be assessed, independently from the generation of the data and the purpose of the study?
⭐ Question-specific: Which quality aspects of the dataset can only be assessed with a specific research question and method?
Further details will be outlined in the forthcoming EU Data Quality Framework document.
𝐓𝐰𝐨 𝐍𝐨𝐫𝐝𝐢𝐜 𝐨𝐫𝐠𝐚𝐧𝐢𝐬𝐚𝐭𝐢𝐨𝐧𝐬 𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐞𝐝, 𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠:
🧩 Lars Wallentin, the founder SWEDEHEART, a Swedish Quality of care registry, presented how RCTs can be implemented in registries and the need to view RCTs and RWE as complementary sources of evidence, not alternatives. This sentiment was echoed by regulators at EMA.
🧩 The Finnish Medicines Agency presented their pilot project which is run together with national data-holders to lay the foundation for generation of RWE which is fit-for-purpose for HTA bodies
𝐓𝐡𝐞 𝐤𝐞𝐲 𝐭𝐚𝐤𝐞-𝐡𝐨𝐦𝐞 𝐦𝐞𝐬𝐬𝐚𝐠𝐞𝐬 𝐟𝐨𝐫 𝐭𝐡𝐨𝐬𝐞 𝐨𝐩𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐑𝐖𝐄 𝐬𝐩𝐚𝐜𝐞 𝐰𝐞𝐫𝐞:
👉 Frequent and transparent dialogue and interaction with regulators is key to build trust and raise awareness about the opportunities and limitations of RWD
👉 Given the lack of standardization of RWE and the heterogeneity of RWD quality, EMA must continue to support stakeholders with clear guidance on expectations for data quality assessments, self-explanatory checklist to operationalize EMA data quality frameworks and best practices
👉 RWE to support evaluation of medicines is evolving. To enable its use and establish its value will enhance a safer and more effective use of medicine for patients
