ReviewClinical pharmacology and therapeutics2022
The Current Landscape and Emerging Applications for Real-World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making.
Review in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- Pathways to Real World Evidence From the Real World of School-Based Physical Fitness Testing (SB-PFT).Learning health systems · 2026Article
- Real-World Evidence of Treatment Outcomes in Small Cell Lung Cancer: A Bayesian Mixed Effects and Competitive Risk Approach.JMIR cancer · 2026Article
- A scoping review on using real-world data to evaluate the effectiveness of mHealth applications.NPJ digital medicine · 2026Article
- Review
- Navigating and Advancing Market Access for In Vitro Diagnostics: Understanding the Roles of Key Stakeholders and Policy.Open forum infectious diseases · 2025Article
- The impact of artificial intelligence on biomarker discovery.Emerging topics in life sciences · 2025Article
- A Knowledge-Enhanced Platform (MetaSepsisKnowHub) for Retrieval Augmented Generation-Based Sepsis Heterogeneity and Personalized Management: Development Study.Journal of medical Internet research · 2025Article
- An Assessment of Real-World Evidence and Other Sources Supporting Payer Coverage Decisions for Pharmacogenomic Testing in Psychiatry.Journal of personalized medicine · 2025Article
- Real-world radiology data for artificial intelligence-driven cancer support systems and biomarker development.ESMO real world data and digital oncology · 2025Review
- Seeing the random forest through the decision trees. Supporting learning health systems from histopathology with machine learning models: Challenges and opportunities.Journal of pathology informatics · 2024Review
- A review on the evolving environment of medical device real-world evidence regulation on market access in the USA.Cost effectiveness and resource allocation : C/E · 2024Review
- Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership.BMC medical informatics and decision making · 2024Article
- Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study.Clinical and translational science · 2024Article
- Article
- [Ontologies Applied in Clinical Decision Support Systems for Diabetes].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2023Review
- Harnessing digital health technologies and real-world evidence to enhance clinical research and patient outcomes.Digital healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
Abstract
Real-world data (RWD) and real-world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the healthcare ecosystem to evaluate medical products throughout their lifecycle. Although considerable interest has been given to regulatory decisions supported by RWE for treatment authorization, especially in rare diseases, less attention has been given to RWD/RWE related to in vitro diagnostic (IVD) products and clinical decision support systems (CDSS). This review examines current regulatory practices in relation to IVD product development and discusses the use of CDSS in assisting clinicians to retrieve, filter, and analyze patient data in support of complex decisions regarding diagnosis and treatment. The review then explores how utilizing RWD could augment regulatory body understanding of test performance, clinical outcomes, and benefit-risk profiles, and how RWD could be leveraged to augment CDSS and improve safety, quality, and efficiency of healthcare practices. Whereas we present examples of RWD assisting in the regulation of IVDs and CDSS, we also highlight key challenges within the current healthcare system which are impeding the potential of RWE to be fully realized. These challenges include issues such as data availability, reliability, accessibility, harmonization, and interoperability, often for reasons specific to diagnostics. Finally, we review ways that these challenges are actively being addressed and discuss how private-public collaborations and the implementation of standardized language and protocols are working toward producing more robust RWD and RWE to support regulatory decision making.
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.