In February 2020, the International Society for Pharmacoepidemiology (ISPE) released a position statement on Real World Evidence (RWE). Here is a summary (You can read ISPE’s full statement here):
- ISPE has contributed to the development of RWE methods for more than 30 years
- ISPE applies robust epidemiological, causal inference and data science methods using a wide variety of Real World Data (RWD) sources (e.g., electronic health records and registries)
- Randomized controlled trials (RCTs) will continue to serve as the major evidentiary standard for regulatory approvals, however, RWE derived from well-designed studies, with application of rigorous epidemiologic methods, combined with judicious interpretation, can offer robust evidence regarding safety and effectiveness.
- ISPE is encouraged to see regulatory agencies now considering RWE to support new indications, labeling changes and for approval of new products.
- ISPE members can provide guidance and drive innovative solutions on key RWE issues, including identifying the optimal study design and which data sources are “fit for purpose,” amongst others.
In summary, ISPE leads and drives exciting new developments in RWE via the breadth of experience and expertise in epidemiologic research of its members, and seeks to collaborate with key stakeholders to further the use and science of RWE.