ArticleTherapeutic innovation & regulatory science2023
Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers.
Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed.
- Factors influencing the trustworthiness of non-randomized studies of interventions: a survey of international experts.BMC medicine · 2026Article
- Representativeness of a German AI-enabled data network for secondary epidemiological analysis based on electronic health records.PloS one · 2026Article
- The unregulated majority: who ensures quality in non-submission real-world studies?Frontiers in medicine · 2026Article
- C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke.International journal of stroke : official journal of the International Stroke Society · 2025Article
- European Health Technology Assessment Considerations Related to Gene Therapies in Eyecare: The Neovascular Age-Related Macular Degeneration Example.Journal of market access & health policy · 2025Article
- Real-World Evidence for Baricitinib in the Treatment of Atopic Dermatitis and Alopecia Areata: Systematic Literature Review 2020-2023.Dermatology and therapy · 2025Review
- Transparency in the secondary use of health data: assessing the status quo of guidance and best practices.Royal Society open science · 2025Article
- A Prospective Observational Study to Evaluate the Actual Use of 1% Pimecrolimus in Chinese Patients with Mild-to-Moderate Atopic Dermatitis Affecting Sensitive Skin Areas.Pragmatic and observational research · 2025Article
- Real-world evidence to support regulatory submissions: A landscape review and assessment of use cases.Clinical and translational science · 2024Review
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
This reflection paper presents a consolidated view of EFPIA on the need for principles for good practice in the generation and use of non-interventional studies (NIS), including overarching principles such as the registration of hypothesis evaluating treatment effect (HETE) studies. We first define NIS and the important adjacencies to clinical trials and relationship with real-world evidence (RWE). We then outline the principles for good practice with respect to appropriate research design, study protocol, fit-for-purpose variables and data quality, analytical methods, bias reduction, transparency in conduct and use, privacy management and ethics review. We conclude with recommendations for action for the research community to promote trust and credibility in the use of NIS.
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.