'current; Case-studies; Clinical trial; Health technology; Medical Devices; Medicinal products; Patient care; Regulatory assessment; Regulatory frameworks; Regulatory requirements; Medicine (miscellaneous); Health Informatics; Computer Science Applications; Health Information Management
Abstract :
[en] Digital health technology tools (DHTTs) present real opportunities for accelerating innovation, improving patient care, reducing clinical trial duration and minimising risk in medicines development. This review is comprised of four case studies of DHTTs used throughout the lifecycle of medicinal products, starting from their development. These cases illustrate how the regulatory requirements of DHTTs used in medicines development are based on two European regulatory frameworks (medical device and the medicinal product regulations) and highlight the need for increased collaboration between various stakeholders, including regulators (medicines regulators and device bodies), pharmaceutical sponsors, manufacturers of devices and software, and academia. As illustrated in the examples, the complexity of the interactions is further increased by unique challenges related to DHTTs. These case studies are the main examples of DHTTs with a regulatory assessment thus far, providing an insight into the applicable current regulatory approach; they were selected by a group of authors, including regulatory specialists from pharmaceutical sponsors, technology experts, academic researchers and employees of the European Medicines Agency. For each case study, the challenges faced by sponsors and proposed potential solutions are discussed, and the benefit of a structured interaction among the different stakeholders is also highlighted.
Disciplines :
Pediatrics
Author, co-author :
Colloud, Seya; F. Hoffmann-La Roche Ltd., Basel, Switzerland. seya.colloud.sc1@roche.com
Metcalfe, Thomas; F. Hoffmann-La Roche Ltd., Basel, Switzerland
Belachew, Shibeshih ; Université de Liège - ULiège > Département des sciences cliniques > Neurologie ; Biogen Digital Health International GmbH, Baar, Switzerland
Ammann, Johannes; F. Hoffmann-La Roche Ltd., Basel, Switzerland
Bos, Ernst; F. Hoffmann-La Roche Ltd., Basel, Switzerland
Kilchenmann, Timothy; F. Hoffmann-La Roche Ltd., Basel, Switzerland
Strijbos, Paul; F. Hoffmann-La Roche Ltd., Basel, Switzerland
Eggenspieler, Damien; SYSNAV, Vernon, France
Servais, Laurent ; Université de Liège - ULiège > Département des sciences cliniques ; Muscular Dystrophy UK Oxford Neuromuscular Centre, Department of Paediatrics, University of Oxford, Oxford, UK
Garay, Chloé; Eli Lilly and Company Ltd., Basingstoke, UK
Konstantakopoulos, Athanasios; Eli Lilly and Company Ltd., Basingstoke, UK ; GE Healthcare S.A., Athens, Greece
Ritzhaupt, Armin; Bristol Myers Squibb, Uxbridge, UK
Vetter, Thorsten; European Medicines Agency, Amsterdam, The Netherlands
Vincenzi, Claudia; European Medicines Agency, Amsterdam, The Netherlands
Cerreta, Francesca; European Medicines Agency, Amsterdam, The Netherlands
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