ReviewDrug safety2015
Electronic Health Data for Postmarket Surveillance: A Vision Not Realized.
Review in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review.Pharmacoepidemiology and drug safety · 2023Pooled it
- Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.BMJ (Clinical research ed.) · 2015Pooled it
- Article
- Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards.Drug safety · 2024Article
- Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?Mayo Clinic proceedings. Digital health · 2023Review
- Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.Drug safety · 2023Article
- The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.Healthcare policy = Politiques de sante · 2022Article
- A statistical quality assessment method for longitudinal observations in electronic health record data with an application to the VA million veteran program.BMC medical informatics and decision making · 2021Article
- US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.Clinical trials (London, England) · 2021Article
- The concept of justifiable healthcare and how big data can help us to achieve it.BMC medical informatics and decision making · 2021Review
- Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications.Chinese medicine · 2021Article
- Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use.Evidence-based complementary and alternative medicine : eCAM · 2021Review
- Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies.Pharmacoepidemiology and drug safety · 2020Article
- Bias in pharmacoepidemiologic studies using secondary health care databases: a scoping review.BMC medical research methodology · 2019Article
- The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?Drug safety · 2019Review
- Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records.Drug safety · 2019Article
- Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial.Drug safety · 2018Review
- Big Data and Pharmacovigilance: Data Mining for Adverse Drug Events and Interactions.P & T : a peer-reviewed journal for formulary management · 2018Article
- Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.Therapeutic innovation & regulatory science · 2018Review
- Cross-national health care database utilization between Spain and France: results from the EPICHRONIC study assessing the prevalence of type 2 diabetes mellitus.Clinical epidemiology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
What has been learned about electronic health data as a primary data source for regulatory decisions regarding the harms of drugs? Observational studies with electronic health data for postmarket risk assessment can now be conducted in Europe and the US in patient populations numbering in the tens of millions compared with a few hundred patients in a typical clinical trial. With standard protocols, results can be obtained in a few months; however, extensive research published by scores of investigators has illuminated the many obstacles that prevent obtaining robust, reproducible results that are reliable enough to be a primary source for drug safety decisions involving the health and safety of millions of patients. The most widely used terminology for coding patient interactions with medical providers for payment has proved ill-suited to identifying the adverse effects of drugs. Directly conflicting results were reported in otherwise similar patient health databases, even using identical event definitions and research methods. Evaluation of some accepted statistical methods revealed systematic bias, while others appeared to be unreliable. When electronic health data studies detected no drug risk, there were no robust and accepted standards to judge whether the drug was unlikely to cause the adverse effect or whether the study was incapable of detecting it. Substantial investment and careful thinking is needed to improve the reliability of risk assessments based on electronic health data, and current limitations need to be fully understood.
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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.