EARLY DIALOGUE IN EUROPE: PERSPECTIVES ON VALUE, CHALLENGES, AND CONTINUING EVOLUTION
| Autor: | Mickaël Hiligsmann, Lina Balaisyte, Angelika Joos |
|---|---|
| Přispěvatelé: | RS: CAPHRI - R2 - Creating Value-Based Health Care, Health Services Research |
| Rok vydání: | 2018 |
| Předmět: |
Value (ethics)
Technology Assessment Biomedical Axial coding Drug Industry Social Values Process (engineering) Early dialogue (ED) Interviews as Topic 03 medical and health sciences 0302 clinical medicine Political science Agency (sociology) 030212 general & internal medicine Qualitative Research Pharmaceutical industry Alignment Health economics business.industry 030503 health policy & services Health Policy Health technology assessment (HTA) Health technology Requirements Public relations Europe Synergies Future perspectives MEDICINES Insurance Health Reimbursement Drug and Narcotic Control ASSESSMENT BODIES Regulatory agency 0305 other medical science business Qualitative HEALTH TECHNOLOGY-ASSESSMENT |
| Zdroj: | International Journal of Technology Assessment in Health Care, 34(5), 514-518. Cambridge University Press |
| ISSN: | 1471-6348 0266-4623 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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