ArticleBritish journal of clinical pharmacology2016
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
35 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A systematic review of the early dialogue frameworks used within health technology assessment and their actual adoption from HTA agencies.Frontiers in public health · 2022Pooled it
- Quantitative Evidence Synthesis Methods for the Assessment of the Effectiveness of Treatment Sequences for Clinical and Economic Decision Making: A Review and Taxonomy of Simplifying Assumptions.PharmacoEconomics · 2021Pooled it
- Pooled it
- A Cross-Sectional Survey of Evidence Needs for Medicinal Products in Europe With a Focus on Real-World Evidence.Pharmacoepidemiology and drug safety · 2026Article
- Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies-Experiences, Expectations and Best Practices from Health Technology Developers.Therapeutic innovation & regulatory science · 2025Article
- The PICO Puzzle: Can Public Data Predict EU HTA Expectations for All EU Countries?Journal of market access & health policy · 2025Article
- Evolving Recommendations for Patient Populations Among Oncology Medicines: A Quantitative and Qualitative Analysis.Clinical pharmacology and therapeutics · 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
- 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
- Personalized medicine: when the common becomes the rare.Frontiers in medicine · 2024Article
- Article
- Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement.International journal of technology assessment in health care · 2023Article
- Real-world evidence for regulatory decision-making: updated guidance from around the world.Frontiers in medicine · 2023Review
- Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project.British journal of clinical pharmacology · 2022Review
- The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.International journal of health policy and management · 2022Article
- Challenges and Opportunities for Companies to Build HTA/Payer Perspectives Into Drug Development Through the Use of a Dynamic Target Product Profile.Frontiers in pharmacology · 2022Article
- The Role of Cost-Effectiveness Analysis in Patient-Centered Cancer Care in the Era of Precision Medicine.Cancers · 2021Article
- Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies.Clinical and translational science · 2021Article
- Bridging the gap: Can International Consortium of Health Outcomes Measurement standard sets align outcomes accepted for regulatory and health technology assessment decision-making of oncology medicines.Pharmacology research & perspectives · 2021Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines.
aimsThe present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective.
methodsWe analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies.
resultsThe analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains.
conclusionsThere is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.
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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.