Weller, Karsten
Winders, Tonya A.
McCarthy, Jessica
Saraswat, Pallavi
Chapman-Rothe, Nadine
Raftery, Tara
Bernstein, Jonathan A.
Article History
Received: 5 May 2025
Accepted: 8 July 2025
First Online: 8 August 2025
Declarations
:
: Karsten Weller reports grants from Novartis, Sanofi, and Takeda outside the submitted work and personal fees from Biocryst, Biomarin, CSL Behring, Novartis, Moxie, Takeda outside the submitted work. Tonya A. Winders receives funds for unbranded disease awareness & education from Novartis, AstraZeneca, Sanofi-Regeneron, Amgen, Roche & Genentech outside of the submitted work. Jessica McCarthy is an employee of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA and reports holding shares of Novartis Pharma AG. Pallavi Saraswat is an employee of Novartis Healthcare Pvt Ltd, Hyderabad, India and reports holding shares of Novartis Pharma AG. Nadine Chapman-Rothe is an employee of Novartis Pharma AG, Basel, Switzerland and reports holding shares of Novartis Pharma AG. Tara Raftery is an employee of Novartis Ireland Ltd, Dublin, Ireland and reports holding shares of Novartis Pharma AG. Jonathan A. Bernstein reports grants from Novartis, AstraZeneca, Sanofi-Regeneron, Amgen, Roche, Allakos, Celldex, CSL Behring, Takeda/Shire, BioCryst, Pharming, Ionis, BioMarin, Intellia, Astria, Aretrea, Pharvaris, Blueprint Medicine, Cogent, Telios, Yuhan, Evoimmune, Incyte/Escient, Jasper, Eli Lilly, Allergy Therapeutics, and Genentech outside the submitted work. Personal fees from Novartis, AstraZeneca, Sanofi-Regeneron, Amgen, Roche, Allakos, Celldex, CSL Behring, Takeda/Shire, BioCryst, Pharming, Ionis, BioMarin, and Genentech outside the submitted work.
: This study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki and adhered to the Guidelines for Good Pharmacoepidemiology Practices of the International Society for Pharmacoepidemiology 2016 and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines []. Legal and regulatory requirements, and criteria of a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study were further fulfilled and the ENCePP Code of Conduct was followed []. All study materials, including the translated questionnaire, underwent review by a recognized institutional review board (IRB) globally. This study was reviewed and approved by Pearl IRB (approval number 21-IPSO-157A), which granted an exemption from ongoing oversight based on the nature of the study involving anonymous, self-administered online surveys with no intervention or collection of sensitive personal health information. The Pearl IRB provided global oversight, granting an exemption while ensuring adherence to ethical standards across countries. In addition, local/ethics committee approval was sought and received in Japan (and France). IRB/ethical approval was sought for this study based on the rationale that while the study included “living people” who completed the quantitative internet-based survey, no articles or substances were tested. An exemption from ongoing oversight was sought after and obtained from an IRB, who reviewed and granted international approval. Informed opt-in consent was requested from respondents prior to the initiation of fieldwork. Irrespective of the sample origin, all participants electronically acknowledged receipt of their informed consent forms before initiating the survey. All physicians read and signed informed consent forms electronically before survey participation. The informed consents were approved by IRB/EC and complied with the Declaration of Helsinki as well as regulatory requirements. Adherence to research and regulatory standards ensured that the rights, safety, and well-being of patients in noninterventional studies were protected, in line with the principles originating from the Declaration of Helsinki.