Pharma’s Almanac


Read the full article >>

Sonja Wustrack, Managing Director of Integrated Evidence Generation, OM1

There are two points to this question around RWD and RWE today. The first piece is the misconception that we primarily need larger volumes of higher quality RWD and better data standards to shift the paradigm for clinical research to incorporate RWE generation. The second piece, which is often cited as a barrier, is the lack of definitive guidelines from the FDA and regulators on the use of RWE to support product approvals.

Instead, the real work that will drive change is around increased collaboration between stakeholders: organizations need to promote new ways of working and a culture of experimentation when it comes to RWD and RWE. Infrastructure, business models, internal resources, and know-how are missing. In addition, new types of data partnerships (non-traditional data vendors) and curation standards are key to rich RWD rather than just volume. Technologies to extract data and innovations, such as artificial intelligence, are critical to enable a more personalized view of patients. Finally, while regulators are making public statements and publishing support for the use of RWD/RWE in submissions, I believe we cannot wait for prescriptive guidelines, but rather we as an industry need to create the standards. Other pressures and factors are driving increased focus of RWE within organizations, including pricing pressures and the need to show value.