Trial reportPharmacoepidemiology and drug safety2017
Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.
Trial report in Pharmacoepidemiology and drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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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
7 citing papers in PubMed, 11 citations in OpenAlex.
- Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.Pharmacoepidemiology and drug safety · 2017Trial
- Safety data in randomised real-world evidence studies: Salford Lung Study learnings.ERJ open research · 2021Review
- Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies.The International journal of pharmacy practice · 2020Article
- Real-World Data and Randomised Controlled Trials: The Salford Lung Study.Advances in therapy · 2020Review
- Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe.Clinical pharmacology and therapeutics · 2019Article
- The Salford Lung Study: a pioneering comparative effectiveness approach to COPD and asthma in clinical trials.Pragmatic and observational research · 2017Review
- Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management.Therapeutic advances in respiratory diseaseObservational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records.
objectiveThe objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. ACHIEVEMENTS: The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected.
conclusionIntegration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
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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.