Pre-Registration of protocols: A Call to Action for ISPE Members
Pre-registration is a crucial practice in scientific research that enhances transparency, credibility, and reproducibility. Regulatory agencies, journals, and funding bodies increasingly recognize pre-registration as a mark of commitment to rigorous research practices. Within pharmacoepidemiology, however, pre-registration is far from the norm.
To address this, ISPE, in collaboration with ISPOR and Duke-Margolis, helped create the RWE Registry—a flexible and user-friendly platform hosted on the Open Science Framework. ISPE recognizes that some members are required to use the HMA-EMA Catalogue for regulatory purposes. While this remains an important resource, its adoption outside of Europe is limited. Other platforms, such as ClinicalTrials.gov, are not designed for database research, making pre-registration challenging for many in the RWE community.
The RWE Registry is designed specifically for RWE studies, streamlining protocol registration with minimal metadata while allowing clear documentation of amendments and study materials over the study lifecycle.
However, awareness of the RWE Registry remains low, limiting its impact. By increasing adoption, we can strengthen the credibility of RWE research and ensure that ISPE members remain at the forefront of scientific integrity and innovation.
Pre-registration is not about restricting research—it’s about making it stronger. Whether using the RWE Registry, the HMA-EMA Catalogue, or other platforms, ISPE members play a crucial role in advancing best practices.
Get started today: RWE Registry
Let’s work together to make real-world evidence more transparent, reproducible, and impactful.
