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<p>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., &gt; 2&#xa0;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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年2月26日

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  • Marie Picci,
  • Nigel S. Cook,
  • Byron Jones,
  • Mo Zhou,
  • Conny Berlin,
  • Christine Sturchler,
  • Clemence Martinez,
  • Irene Garcia Baena,
  • Lauren Ziegler,
  • Harriet Gaunt,
  • Brad Mason,
  • Dominique Hamerlijnck,
  • Yoshiyuki Majima

摘要

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.