Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives
This paper describes the planning of a patient preference study for evaluating device features for the subcutaneous (SC) delivery of high dose/large volume (e.g., > 2 ml) of drugs. Multiple sources, including qualitative patient interviews, the involvement of patient partners, and solicitation of advice from the US Food and Drugs Administration (FDA), were used to refine the attributes and levels in the development of a preference study protocol to investigate what Multiple Sclerosis (MS) patients consider important regarding medical device features for high dose SC administration.
Authors
- Mo Zhou (ORCID: https://orcid.org/0000-0003-4772-9838)
- Nigel S. Cook (ORCID: https://orcid.org/0000-0001-8211-7613)
- Marie Picci
- Conny Berlin (ORCID: https://orcid.org/0000-0002-5904-5057)
- Lauren Ziegler
- Brad Mason
- Dominique Hamerlijnck (ORCID: https://orcid.org/0000-0001-8464-0547)
- Byron Jones (ORCID: https://orcid.org/0000-0002-0240-2906)
- Yoshiyuki Majima
- Harriet Gaunt
- Irene Garcia Baena
- C. MARTINEZ
- Christine Sturchler
Institutions
- Novartis (Switzerland) (CH)
- Adelphi Group (United Kingdom) (GB)
- Novartis (United States) (US)
- Atria (NL)
Publication Details
- Journal
- Therapeutic Innovation & Regulatory Science
- Published
- 2025-02-26
- DOI
- https://doi.org/10.1007/s43441-024-00725-3
- Citations
- 3
- Primary Topic
- Multiple Sclerosis Research Studies
- Type
- article
- Field-Weighted Citation Impact
- 4.41
Funders
- Breast Cancer Research Foundation
- Novartis Pharma