van Rensen Annemiek, Voogdt-Pruis Helene R, Vroonland Eva
PGOsupport, Utrecht, Netherlands.
Department of Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
Front Med (Lausanne). 2020 Sep 11;7:558. doi: 10.3389/fmed.2020.00558. eCollection 2020.
Involving patients' representatives in the research and development of medicinal products (medicines R&D) leads to better medical treatment. In 2014, the European Patients' Academy on Therapeutic Innovation (EUPATI) was started with the goal of increasing the capacity and capabilities of patient representatives in this field. To make this academy more accessible and applicable for the Netherlands, a Dutch version was launched in September 2019. To explore the options for a durable infrastructure for organizing the Dutch EUPATI course, a multi-stakeholder qualitative study was done. The views of various stakeholders from pharmaceutical industry, governmental organizations, patient organizations, and the academic world were examined about the benefits and challenges of this course for patient involvement in medicines R&D. From April to June 2019, 10 semi-structured interviews were completed, each with two representatives of all stakeholders involved. In addition, individual Dutch graduates of the European EUPATI (EUPATI fellows) were consulted an e-mail questionnaire. Using a directed content analysis based on the Business Canvas Model, the transcribed interviews were coded, analyzed, and final attributes consolidated. The semi-structured interviews and completed questionnaires explored how the stakeholders are aiming to assist patient involvement in medicines R&D through the Dutch EUPATI course. The building blocks of the Business Canvas Model were described with concrete attributes for making the business case. Stakeholders stated that the Dutch EUPATI course was an incentive for patient involvement in medicines development, for patient-oriented research and outcomes, for the availability of patient representatives (expert ones in particular), and for the content and representation quality of patient representatives. The key values for collaborating in the network as mentioned by the stakeholders were neutrality, patients' interests, equality, independence, shared objectives, long-term commitment, transparency, understanding, trust, and respect. Patient involvement in medicines R&D is evolving and the demand for qualified patient representatives is growing. Dutch stakeholders confirmed the added value of the patients' academy and expressed their willingness to contribute. Important values and conditions for long term collaboration were formulated.
让患者代表参与药品研发能带来更好的医疗效果。2014年，欧洲治疗创新患者学会（EUPATI）成立，目标是提高患者代表在该领域的能力。为使该学会更便于荷兰人使用和应用，2019年9月推出了荷兰语版本。为探索组织荷兰EUPATI课程的持久基础设施的选项，开展了一项多利益相关方定性研究。研究考察了制药行业、政府组织、患者组织和学术界等不同利益相关方对该课程在患者参与药品研发方面的益处和挑战的看法。2019年4月至6月，完成了10次半结构化访谈，每次访谈涉及所有利益相关方的两名代表。此外，还通过电子邮件问卷咨询了欧洲EUPATI的荷兰毕业生（EUPATI研究员）个人。基于商业画布模型进行定向内容分析，对转录的访谈进行编码、分析，并整合最终属性。半结构化访谈和完成的问卷探讨了利益相关方如何旨在通过荷兰EUPATI课程协助患者参与药品研发。用具体属性描述了商业画布模型的构建要素以制定商业案例。利益相关方表示，荷兰EUPATI课程是患者参与药品研发、开展以患者为导向的研究和成果、提供患者代表（特别是专家代表）以及提高患者代表的内容和代表性质量的一项激励措施。利益相关方提到的在网络中合作的关键价值包括中立性、患者利益、平等、独立性、共同目标、长期承诺、透明度、理解、信任和尊重。患者参与药品研发正在不断发展，对合格患者代表的需求也在增加。荷兰利益相关方确认了患者学会的附加值，并表示愿意做出贡献。制定了长期合作的重要价值和条件。
