ReviewTherapeutic advances in drug safety2020
Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance.
Review in Therapeutic advances in drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed.
- Quality of adverse drug reaction reports submitted to the national pharmacovigilance center of Nepal: a pre- and post-training evaluation.BMC medical education · 2026Article
- Safety and risk management in clinical trials for chronic wounds with tissue regenerative products.Therapeutic advances in drug safety · 2026Article
- Impact of social determinants of health on safety of patients in device clinical trials conducted at a safety-net hospital.Therapeutic advances in drug safety · 2025Article
- Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.Current drug safety · 2025Review
- Prostaglandin analogues signal detection by data mining in the FDA Adverse Event Reporting System database.BMJ open ophthalmology · 2024Article
- Biosimilars in the Era of Artificial Intelligence-International Regulations and the Use in Oncological Treatments.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Detection of novel drug-adverse drug reaction signals in rheumatoid arthritis and ankylosing spondylitis: analysis of Korean real-world biologics registry data.Scientific reports · 2024Article
- Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance.Drug safety · 2024Review
- Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations.Advances in therapy · 2023Review
- Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.Therapeutic advances in drug safety · 2023Review
- Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.Therapeutic advances in drug safety · 2023Article
- Pharmacovigilance: reporting requirements throughout a product's lifecycle.Therapeutic advances in drug safety · 2022Review
- The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.International journal of environmental research and public health · 2021Review
- Praziquantel and Upper Gastrointestinal Bleeding in Hepatic Schistosomiasis: A Quasi-Experimental Study.Drugs - real world outcomes · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, etc.).
Indexed as
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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.