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Article History

Received: 17 December 2024

Accepted: 1 May 2025

First Online: 2 June 2025

Declarations

:

: Stefan Braune received honoraria from Kassenärztliche Vereinigung Bayerns and health maintenance organizations for patient care; and from, Merck, NeuroTransData, Novartis, Sanofi and Roche for consulting, project management, clinical studies, and lectures; he also received honoraria and expense compensation as a board member of NeuroTransData. Petra Dirks was an employee of F. Hoffmann-La Roche Ltd during completion of this work and is a shareholder in F. Hoffmann-La Roche Ltd; her current affiliation is Carl-von-Ossietzky University, Oldenburg, Germany. Seya Colloud is an employee of and a shareholder in F. Hoffmann-La Roche Ltd. Evan Davies is an employee of and a shareholder in F. Hoffmann-La Roche Ltd. Qing Wang is an employee of and a shareholder in F. Hoffmann-La Roche Ltd. Yanic Heer was contracted to perform statistical projects for NeuroTransData and was an employee of PricewaterhouseCoopers AG during completion of this work. Mel Zürcher was contracted to perform statistical projects for NeuroTransData and was an employee of PricewaterhouseCoopers AG during completion of this work. Diana Sun is an employee of Genentech, Inc., and a shareholder in F. Hoffmann-La Roche Ltd. Arnfin Bergmann received consultancy fees from advisory board, speaker, and other activities for NeuroTransData; project management and clinical studies from Novartis and Servier.

: The data acquisition protocol was approved by the ethical committee of the Bavarian Medical Board (Bayerische Landesärztekammer, June 14, 2012, No. 11144) and reapproved by the ethical committee of the Medical Board North-Rhine (Ärztekammer Nordrhein, April 25, 2017, ID 2017071). The study conforms to the World Medical Association Declaration of Helsinki as published on the website of the Journal of American Medical Association, the Guidelines for Good Pharmacoepidemiology Practices (GPP) published by the International Society of Pharmacoepidemiology (ISPE), and the laws and regulations of Germany. Patient inclusion with informed consent is completed in the respective NTD practice as part of routine clinical care. Patients included in this analysis provided their informed consent (via tablets in NTD practices, electronic questionnaires, or via a patient portal) to the NTD registry. Patients explicitly agreed to secondary use of their data. All personnel undergo regular training to ensure quality of data in the registry. Both automatic and manually executed queries are implemented to further ensure data quality []. All data are pseudonymized and pooled to form the NTD registry.