ArticleBMJ open2023
Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts.
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 19 citations in OpenAlex.
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- Beyond the Pill: Mapping Process-Oriented Decision Support Models in Pharmaceutical Policy.Healthcare (Basel, Switzerland) · 2025Review
- Evolving Recommendations for Patient Populations Among Oncology Medicines: A Quantitative and Qualitative Analysis.Clinical pharmacology and therapeutics · 2025Article
- Stakeholders' Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey.Drug safety · 2025Article
- Improving access to innovation from international health technology assessment.International journal of technology assessment in health care · 2025Article
- Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy.Journal of market access & health policy · 2025Article
- Multiple Perspectives on the Need for Real-World Evidence to Inform Regulatory and Health Technology Assessment Decision-Making: Scoping Review and Stakeholder Interviews.Pharmacoepidemiology and drug safety · 2025Article
- Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.Health research policy and systems · 2024Article
- The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments.Drug safety · 2024Article
- The arisal of data spaces: why I am excited and worried.Frontiers in immunology · 2024Article
- Getting ready for the European Health Data Space (EHDS): IDERHA's plan to align with the latest EHDS requirements for the secondary use of health data.Open research Europe · 2024Article
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveImproving synergy among regulation, health technology assessment (HTA) and clinical guideline development is relevant as these independent processes are building on shared evidence-based grounds. The two objectives were first to assess how convergence of evidentiary needs among stakeholders may be achieved, and second, to determine to what extent convergence can be achieved.
designQualitative study using eight online dual-moderator focus groups.
settingDiscussions had a European focus and were contextualised in four case studies on head and neck cancer, diabetes mellitus, multiple sclerosis and myelodysplastic syndromes.
participantsForty-two experienced (over 10 years) European regulators, HTA representatives and clinicians participated in the discussion.
interventionsParticipants received information on the case study and research topic in advance. An introductory background presentation and interview guide for the moderators were used to steer the discussion.
resultsConvergence may be achieved through improved communication institutionalised in multistakeholder early dialogues, shared definitions and shared methods. Required data sets should be inclusive rather than aligned. Deliberation and decision-making should remain independent. Alignment could be sought for pragmatic clinical trial designs and patient registries. Smaller and lower-income countries should be included in these efforts.
conclusionActors in the field expressed that improving synergy among stakeholders always involves trade-offs. A balance needs to be found between the convergence of processes and the institutional remits or geographical independence. A similar tension exists between the involvement of more actors, for example, patients or additional countries, and the level of collaboration that may be achieved. Communication is key to establishing this balance.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.