ArticleBritish journal of clinical pharmacology2017
Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.
Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
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
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient-reported outcomes in randomized controlled trials to support clinical decision-making.Cancer medicine · 2020Pooled it
- Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post-authorization studies, 2022-2024.British journal of clinical pharmacology · 2026Review
- Six-Year Trends in Real-World Data Use for Post-Marketing Surveillance of New Medical Products in Japan.Clinical and translational science · 2026Review
- Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Article
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information.Frontiers in drug safety and regulation · 2025Article
- Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU.Frontiers in medicine · 2024Review
- Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance.British journal of clinical pharmacology · 2022Article
- Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy.Journal of patient-reported outcomes · 2022Review
- Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018.Pharmacoepidemiology and drug safety · 2022Article
- Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns.Pharmaceutical medicine · 2022Article
- Effectiveness of Additional Risk Minimization Measures for Atezolizumab in the European Union.Pharmaceutical medicine · 2021Article
- A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.Pharmacoepidemiology and drug safety · 2021Review
- Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model.Clinical pharmacology and therapeutics · 2020Review
- Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.British journal of clinical pharmacology · 2020Review
- Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate 'Real World' Evidence of Comparative Effectiveness and Safety.Drug safety · 2019Article
- Harnessing the patient voice in real-world evidence: the essential role of patient-reported outcomes.Nature reviews. Drug discovery · 2019Article
- EU postmarket surveillance plans for medical devices.Pharmacoepidemiology and drug safety · 2019Review
- Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation.
methodsA systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages.
resultsDuring the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints.
conclusionsTo the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines.
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Registered trials
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