The Challenges of Regulatory and  HTA Bodies in RWE –

An interesting qualitative article by Silvers H. et al. about the perspectives on challenges, values & alignment of regulatory and HTA bodies. Great findings which could be an excellent opportunity for quantitative research if saturation was reached in all interviewed groups.  

Regulatory and HTA bodies need different documents, have different perspectives, and level of uncertainty acceptance cause theirs unlike tendency in using RWE. Despite these differences, both see the values of RWE as a source to complement clinical data, to reduce the uncertainty in trial findings and helpful in situations where RCTs are impractical. However, at the same time, both bodies concern the quality of RWD and lack of standardization in RWD collection on top of the HTA bodies’ concern about comparative information and outcome measures.

The findings of this article can be generalized to many other jurisdictions. There are already some platforms to combine different EMRs, some criteria to rank data sources. However, we still need to standardize the RWD from various sources and define some criteria to decide the quality of RWD for regulatory and HTA purposes.