29 September 2021 - Deborah Wilkes
- AESGP-funded paper published in Clinical and Translational Science journal
- Real-world evidence increasingly used for prescription medicines
- Limited use to date for non-prescription medicines
- Different approach required for non-prescription medicines
- Further dialogue between industry and regulators needed
If real-world evidence (RWE) is to reach its full potential for non-prescription medicines, there needs to be “further dialogue” between industry and regulatory bodies, argues a paper just published in the journal Clinical and Translational Science.
The paper – which was funded by the Association of the European Self-Care Industry (AESGP) – points out RWE is increasingly used in decision-making for prescription-only medicines but there has been limited activity in the non-prescription sector.
Opportunities to use RWE in the non-prescription sector, says the paper, are likely to increase with the growth of person-generated health data (PGHD), an emerging source of real-world data (RWD) boosted through digital technologies.
The paper says PGHD could be used to generate RWE in a variety of settings, ranging from prospective clinical trials to retrospective observational studies.
Mobile phone sensors, electronic apps and consumer wearables can generate RWD relevant to non-prescription medicines, says the paper, noting this could provide evidence of effectiveness, quality of life or adherence as part of prospective or retrospective studies.
The paper says “RWD derived from PGHD has the potential to demonstrate additional benefits on real-world impacts that are more relevant to the end user, and which go beyond treatment benefits captured in clinical trials”.
However, the paper notes that the use of PGHD to generate RWE for non-prescription medicines is largely unexplored.
Filling gaps and complementing knowledge
The paper points out that data from real-world studies play a vital role in filling data gaps and complementing existing knowledge on safety, efficacy and benefit-risk – including clinical trial data – during key parts of the lifecycle of non-prescription medicines.
The paper maintains that a different approach to RWE is needed in the non-prescription sector, as the available sources of RWD and evidence requirements differ from the prescribed sector.
“RWD should be defined widely by regulators to include data generated from real-world studies,” says the paper, “as very few data are routinely collected on non-prescription medicines.”
“It is important to apply other approaches – both from industry and regulators – to reap the benefits for individuals and health systems,” the paper states.
Aid to decision-making
The paper focuses on how RWD and RWE can aid decision-making during the lifecycle of non-prescription medicines.
RWE currently plays a role during specific stages of the non-prescription medicine lifecycle, says the paper, citing switching, post-marketing safety surveillance and investigating real-world effectiveness.
Commenting on switching medicines from prescription-only to non-prescription status, the paper notes that some data requirements cannot be met through conventional randomised controlled trials. “RWE from actual-use trials will continue to play a key role in reclassification applications,” it says.
“Working towards a common understanding of where and how RWE could be of value in aiding decision-making is critical to ensuring real-world data (RWD) can be leveraged appropriately,” states the paper.
The lead author for the paper is Bayer Consumer Health’s Emese Csoke.