ArticleBritish journal of clinical pharmacology2019
Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Evaluation of reporting quality of cohort studies using real-world data based on RECORD: systematic review.BMC medical research methodology · 2023Pooled it
- Drug repurposing against viral infections (2020-2025): clinical trials, computational strategies, and therapeutic interventions.Inflammopharmacology · 2026Review
- Navigating challenges and opportunities in orphan medicines: A spotlight commentary on rare diseases.British journal of clinical pharmacology · 2025Article
- Expanding the use of real-world data through the development of user-friendly tools to support drug development: Example of an organ impairment dashboard.Pharmacology research & perspectives · 2024Article
- Next-generation study databases require FAIR, EHR-integrated, and scalable Electronic Data Capture for medical documentation and decision support.NPJ digital medicine · 2024Article
- Psychostimulants and social behaviors.Frontiers in pharmacology · 2024Review
- Innovative thinking of clinical investigation for rare disease drug development.Orphanet journal of rare diseases · 2023Review
- A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments.Diabetes care · 2023Review
- Harnessing Real-World Evidence to Advance Cancer Research.Current oncology (Toronto, Ont.) · 2023Review
- RWD-Cockpit: Application for Quality Assessment of Real-world Data.JMIR formative research · 2022Article
- Real-world use of orphan medicinal products (OMPs) in rare disease (RD) patients: A population-based registry study.Frontiers in pharmacology · 2022Article
- Key Learnings from Running an Extension Study to a Real-World Effectiveness Trial: The Extended Salford Lung Study.Advances in therapy · 2021Article
- Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model.Frontiers in medicine · 2021Article
- Real-world longitudinal data collected from the SleepHealth mobile app study.Scientific data · 2020Article
- Cost-effectiveness of long-acting insulin analogues vs intermediate/long-acting human insulin for type 1 diabetes: A population-based cohort followed over 10 years.British journal of clinical pharmacology · 2020Article
- Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.British journal of clinical pharmacology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Radically expanding use of real-world data (RWD) and real-world evidence (RWE) holds the potential to substantially impact drug development, pharmaceutical regulation, and payment within health care systems. Central to this is the reconfiguration of data gathering and transformation of data to information, which can be used as evidence for decision making. We discuss applications of this paradigm in the light of recent developments in both the United States and Europe on RWD and RWE.
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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.