ArticleF1000Research2018
Real world evidence (RWE) - a disruptive innovation or the quiet evolution of medical evidence generation?
Article in F1000Research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers, 6 of them syntheses 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
70 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Availability of secondary healthcare data for conducting pharmacoepidemiology studies in Mexico: a systematic review.Journal of comparative effectiveness research · 2026Pooled it
- Real-World Effectiveness of SGLT2 Inhibitors Across Heart Failure Phenotypes: A Meta-Analysis.Journal of diabetes research · 2026Pooled it
- Patient experience and burden of haemolytic disease of the foetus and newborn: a systematic review.BMC pregnancy and childbirth · 2025Pooled it
- Real-World Effectiveness of Triple Extrafine Fixed-Dose Combination with Beclomethasone/Formoterol/Glycopyrronium on Symptoms and Lung Function in COPD: A Systematic Review and Meta-Analysis.International journal of chronic obstructive pulmonary disease · 2025Pooled it
- Availability of secondary healthcare data for conducting pharmacoepidemiology studies in Colombia: A systematic review.Pharmacology research & perspectives · 2020Pooled it
- Pooled it
- Just-in-Time Adaptive Intervention for Stabilizing Sleep Hours of Japanese Workers: Microrandomized Trial.Journal of medical Internet research · 2024Trial
- Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner.Pharmaceutical medicine · 2026Article
- Use of Real-World Evidence in Health Technology Assessments of Non-Oncology Rare Disease Therapies.Journal of market access & health policy · 2026Article
- COVID-19 and its short- and long-term effects on the operations of the EMA: fostering innovation in the EU during and beyond time of crisis.European journal of public health · 2026Review
- Advancing real-world evidence harmonization: lessons from the UK, EMA and global policy frameworks.Journal of comparative effectiveness research · 2026Review
- A review of use of external data and update on reporting standards in Sequential Multiple-Assignment Randomised Trials.Clinical trials (London, England) · 2026Review
- Value of Clinical Evidence and Health Economics and Outcomes Research (HEOR) Studies.Muscle & nerve · 2026Review
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part I-Coordinated Registry Networks and Systemic Coordinated Inter-Organizational Networks.International journal of translational medical research and public health · 2025Article
- Atopic dermatitis occurrence and progression and allergen immunotherapy: A real-world, retrospective cohort study in Germany.The World Allergy Organization journal · 2025Article
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- The real world of acute lymphoblastic leukemia.Haematologica · 2025Article
- Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings.Frontiers in drug safety and regulation · 2025Article
- The relevance of the real-world evidence in research, clinical, and regulatory decision making.Frontiers in public health · 2025Review
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part III-Questions for Translational Science and Action Theory.International journal of translational medical research and public health · 2025Article
10 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.
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.