Jones, Byron, Berlin, Conny, Ziegler, Lauren, Sturchler, Christine, Picci, Marie, Martinez, Clemence, Zhou, Mo, Garcia Baena, Irene, Cook, Nigel, Gaunt, Harriet, Mason, Brad, Hamerlijnck, Dominique and Yoshiyama, Majima (2025) Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives. Therapeutic innovation & regulatory science.

Abstract

This paper describes the planning of a patient preference study for evaluating device features and administrative solutions for the subcutaneous (SC) delivery of high doses / large volumes (e.g., >2mL) of drugs.

A mixed-methods approach was used including qualitative research studies, the involvement of patients as research partners, and solicitation of advice from the FDA. This resulted in the development of a preference study protocol to investigate what people living with MS (PLwMS) consider important regarding medical device features for high dose SC administration, including refinement of the attributes and levels which will be central to the planned quantitative online patient preference study.

Item Type:	Article
Keywords:	Patient Preferences; Patient Experience Data; Scientific Advice; Subcutaneous Delivery; Device Features
Date Deposited:	01 Apr 2025 00:45
Last Modified:	01 Apr 2025 00:45
URI:	https://oak.novartis.com/id/eprint/53920