EARLY DIALOGUE IN EUROPE: PERSPECTIVES ON VALUE, CHALLENGES, AND CONTINUING EVOLUTION
EARLY DIALOGUE IN EUROPE: PERSPECTIVES ON VALUE, CHALLENGES, AND CONTINUING EVOLUTION
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DOI：
10.1017/s0266462318000545
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发表时间：
2018-01-01
影响因子：
3.2
通讯作者：
Hiligsmann, Mickael
中科院分区：
文献类型：
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作者：
Balaisyte, Lina;Joos, Angelika;Hiligsmann, Mickael
目标：本研究的目的是评估参与者的意见，以前的经验，目前的形势和未来的前景，制药行业，监管机构和卫生技术评估机构（HTABs）之间的早期对话在Europe.Methods：11个半结构化的采访安排有目的的有经验的人从制药行业，欧洲药品管理局，卫生经济学的专家。访谈的问题主要集中在早期对话的价值、早期对话过程中面临的挑战、开始早期对话的最佳时机、最适合早期对话的产品类型、早期对话过程的现状和未来展望等方面。访谈记录，然后转录为开放和轴向编码，总结findings.Results：所有受访者一致认为，早期对话是一个有价值的过程，有助于告知发展计划，并相应地为患者提供更快地获得新药。然而，在这一阶段，制药业承认某些挑战：（一）在制药公司和HTAB内部寻找资源，以支持早期对话（二）监管机构和HTAB之间的要求在不同的countries diverge.Conclusions：这项研究表明，人们从制药行业认为早期对话作为一个有价值的工具，可以使药物更快地为患者提供精简的发展。然而，需要缓解上述挑战，以建立可持续的早期对话机制。
Objectives:This study aims to assess participants' views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTABs) in Europe.Methods:Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the European Medicines Agency, and an expert in Health Economics. The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarize the findings.Results:All interviewees agreed that early dialogue is a valuable process that helps to inform the development program and accordingly provide patients with faster access to new medicines. However, at this stage, the pharmaceutical industry acknowledged certain challenges: (i) Finding resources within pharmaceutical companies and HTABs to support early dialogues (ii) Requirements between regulators and HTABs in different countries diverge.Conclusions:This study revealed that people from the pharmaceutical industry perceive early dialogue as a valuable tool that can bring medicines to patients faster by streamlining development. However, the challenges mentioned above need to be mitigated to build a sustainable mechanism for early dialogue.