Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST

David Nobbs; Wojciech Piwko; Christopher Bull; Francesca Cormack; Teemu Ahmaniemi; Sebastian C Holst; Meenakshi Chatterjee; Walter Maetzler; Stefan Avey; Wan Fai Ng; IDEA-FAST Consortium

doi:10.1159/000533189

Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST

Digit Biomark. 2023 Sep 19;7(1):132-138. doi: 10.1159/000533189. eCollection 2023 Jan-Dec.

Authors

Affiliations

¹ Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
² Takeda Pharmaceuticals International, Zurich, Switzerland.
³ Open Lab, School of Computing, Newcastle University, Newcastle upon Tyne, UK.
⁴ Cambridge Cognition, Cambridge, UK.
⁵ VTT Technical Research Center of Finland Ltd., Espoo, Finland.
⁶ Janssen Research and Development, Cambridge, MA, USA.
⁷ Department of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, Germany.
⁸ Janssen Research and Development, Spring House, PA, USA.
⁹ Translational and Clinical Research Institute, Newcastle University and NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

Abstract

Background: Innovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency (EMA) to receive advice on its plans for regulatory qualification of the measures. This viewpoint reviews the IDEA-FAST perspective on developing digital measures for multiple diseases and the advice provided by the EMA.

Summary: The EMA considered a cross-disease measure an interesting and arguably feasible concept. Developers should account for the need for a strong rationale that the clinical features to be measured are similar across diseases. In addition, they may expect increased complexity of study design, challenges when managing differences within and between disease populations, and the need for validation in both heterogeneous and homogeneous populations.

Key messages: EMA highlighted the challenges teams may encounter when developing a cross-disease measure, though benefits potentially include reduced resources for the technology developer and health authority, faster access to innovation across different therapeutic fields, and feasibility of cross-disease comparisons. The insights included here can be used by project teams to guide them in the development of cross-disease digital measures intended for regulatory qualification.

Keywords: Digital evidence; Regulatory science; Wearables.

Grants and funding

The IDEA-FAST project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 853981. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and associated partners.