Zhaohui Su, VP of Biostatistics at Ontada, shared a post by Massoud Toussi, Real-World Evidence and Epidemiology Leader at Toussilver and Editor-in-Chief at Epidemiology Open Access Journal, adding:
“The ICH M14 Guideline provides harmonized international principles for planning, designing, analyzing, and reporting non-interventional studies using real-world data (RWD) for the safety assessment of medicines. It emphasizes robust methodology, data quality, bias minimization, and transparent reporting to support regulatory decision-making and improve global acceptance of study results.”
Quoting Massoud Toussi‘s post:
“The “Wild West” of RWE methodology is officially coming to an end. The adoption of the ICH M14 guideline in late 2025 marks a historic shift toward global harmonization. For those of you who know me, this is something I have been asking from the community since 2014! Now, for the first time, regulators from the US, EU, Japan, Canada, and beyond have agreed on a single set of “General Principles” for non-interventional safety studies using RWD.
The new global standard requires:
- Â Protocol Pre-specification: You must register your study design before looking at the data to prevent “cherry-picking” results.
- Â Fit-for-Purpose Data: A rigorous, two-phase feasibility assessment to prove your data source can actually answer your research question.
- Â “Show Your Work”: A focus on transparency and data lineage that allows for complete reproducibility.
This is indeed what a lot of us have been doing as normal procedure, but I know that a lot of”others” did not.
This is the “GCP moment” for Real-World Evidence. By harmonizing these standards, a single RWE study can now support regulatory submissions across multiple continents simultaneously.