Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives

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 patient partners, and solicitation of advice from the FDA. This resulted in the development of a preference study protocol to investigate what Multiple Sclerosis patients 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.