Protocol design study outlines attribute selection for subcutaneous injection devices in multiple sclerosis, highlighting the integration of regulatory 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.
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Picci et al. (2025) studied this question.
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