ReviewBritish journal of clinical pharmacology2020
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Review in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 36 citations in OpenAlex.
- Collective international action to increase access to costly drugs: pooled procurement and equity based tiered pricing.BMJ (Clinical research ed.) · 2025Article
- Enhancing Development Strategies Through Early Scientific Advice from HTA Agencies-Experiences, Expectations and Best Practices from Health Technology Developers.Therapeutic innovation & regulatory science · 2025Article
- Planning Post-Launch Evidence Generation: Lessons From France, England and Spain.Clinical pharmacology and therapeutics · 2025Review
- Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review.Frontiers in drug safety and regulation · 2025Review
- An operationalization framework for lifecycle health technology assessment: a Health Technology Assessment International Global Policy Forum Task Force report.International journal of technology assessment in health care · 2024Review
- The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments.Drug safety · 2024Article
- Stakeholder perspectives on cooperation in the clinical and nonclinical health technology assessment domains.International journal of technology assessment in health care · 2023Article
- 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 Data in Health Technology Assessment of Complex Health Technologies.Frontiers in pharmacology · 2022Article
- Current landscape of clinical development and approval of advanced therapies.Molecular therapy. Methods & clinical development · 2021Review
- Towards a better use of scientific advice for developers of advanced therapies.British journal of clinical pharmacology · 2021Article
- The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy.Frontiers in pharmacology · 2021Article
- Registries for orphan drugs: generating evidence or marketing tools?Orphanet journal of rare diseases · 2020Article
- 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
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 6 institutions in 12 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision-making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.
Indexed as
Identifiers
What OpenQuestion holds
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.