Abstract
During the last few years, the pharmaceutical industry has adopted digital technologies/digital health technology (DHT) to improve the drug development process and the commercialization of new products. Technological advances are strongly supported by both the US-FDA and the EMA, but the regulatory landscape in the US seems to be more suitable to promote innovation in the digital health sector (e.g. Cures Act). In contrast, the new Medical Device Regulation sets high hurdles for Medical Device software to pass regulatory scrutiny.
On both sides of the Atlantic, a digital tool must be fit-for-purpose for the intended use in the clinical drug trial. Irrespective of its status as a Medical Device, at least the basic safety and performance requirements according to local regulations should be met, quality system and surveillance requirements should be fulfilled, and the sponsor must ensure conformity with GxP and the local data privacy and cybersecurity legislations.
There is an overlap in technical and clinical validation for drug development tool qualification in both regions to ensure that the digital tools deliver reliable data with tangible clinical benefits. Based on an analysis of the regulatory framework of the FDA and the EMA, this study proposes regulatory strategies for a global pharma company: It would be prudent for drug development companies to a) use approved solutions or b) consider qualification of drug development tools early and in parallel to clinical development. Early engagement with the FDA and the EMA/CA is recommended to define evidentiary standards and corresponding regulatory pathways for different contexts-of-use and to clarify regulator’s expectations as to what extent data collected by digital tools are acceptable to support marketing authorization applications (MAA).
Hence a harmonization of the partly disparate regulatory requirements in the US and the EU accompanied by further development of the regulatory landscape in the EU, could further foster the use of digital tools in drug clinical development. The outlook for the use of digital tools in clinical trials is hopeful.
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All data supporting the findings of this study are available within the paper and its Supplementary Information, via the links as provided in the reference section.
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No financial support was received for the research, authorship, and/or publication of this article. The authors would like to thank Amy Bertha (Research & Development, Pharmaceuticals, Regulatory Affairs, Bayer AG) and Dr. Gerardine Burton (Research & Development, Pharmaceuticals, Regulatory Affairs, Bayer AG) for the support in writing the article.
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Gelis, L., Stoeckert, I. & Podhaisky, HP. Digital Tools—Regulatory Considerations for Application in Clinical Trials. Ther Innov Regul Sci 57, 769–782 (2023). https://doi.org/10.1007/s43441-023-00535-z
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DOI: https://doi.org/10.1007/s43441-023-00535-z