New FDA Regulation to Improve Safety Reporting in Clinical Trials
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The Sentinel Initiative: a national strategy for monitoring medical product safety.Silver
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A process of reporting important adverse events to relevant groups is defined by local regulation.
“a process that is defined by local regulation.284”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [284]
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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
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“Recent regulatory guidance from the FDA has limited the reporting of adverse events in clinical trials from sponsors to those that are unexpected and considered related to the drug [47].”
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“, known adverse effects), and over-reporting of all serious adverse events to all relevant regulatory authorities, ethics committees, and site investigators, which could lead to an overwhelming bulk of reports with rarely useful insights or improved safety [58, 59, 66].”
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“…secondary outcomes were: (1) safety – all AEs or infusion reactions were abstracted and rated as mild, moderate or severe according to guidelines; 66 (2) standard demographic characteristics; (3) pertinent medical histories and results of diagnostic testing; and (4) the standard seven-point PGIC.”
BackgroundThe Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease
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“that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group’(6) suggesting that the events may be caused by the drug.(5) After trial completion, trial registries such as ClinicalTrials.”
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The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative
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Cyclic adenosine monophosphate in acute ischemic stroke: some to update, more to explore
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Lewis, J. H. (2013) · Pharmaceutical Medicine · doi:10.1007/s40290-013-0015-5 · Cited by 23 · see citing works
“This combines both regulatory and clinical definitions in a more meaningful way, and although the new safety reporting rule promulgated by the FDA is specifically aimed at clinical trials [29], it would also appear to have relevance in the post-approval setting.”
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“The FDA’s recently published regulation on safety reporting of controlled trials [46] should enhance safety reporting of serious AEs by clinical trial investigators and the assessment of potential drug-related harms from individual trials.”
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“The project team summarized the compiled responses according to 4 themes: (1) organizational structures, (2) handling of unmasked data from ongoing trials, (3) approaches to integrating safety data across trials and other data sources, and (4) defining thresholds for escalation of safety signals.”
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“AEs, commonly reported by study participants during trial follow-up, follow a regulatory path if they meet criteria for seriousness and represent a key element of the product label.(2,3) Traditionally, these events are captured with unique data elements and criteria, but overlap exists.”
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- Authors
- Behrman Sherman, R., Woodcock, J., Norden, J., Grandinetti, C., & Temple, R. J.
- Affiliations
- United States Food and Drug Administration (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-07-07
- Volume
- 365
- Issue
- 1
- Pages
- 3-5
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2009093622
- Cited by
- 50
- References
- 1
- Citations by year
- 2025: 3 · 2024: 1 · 2023: 2 · 2021: 2 · 2020: 4 · 2018: 3 · 2017: 4 · 2016: 5 · 2015: 2 · 2014: 1 · 2013: 11 · 2012: 5
- FWCI
- 9.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- FDA regulation, safety reporting, clinical trials, medical product safety, adverse event monitoring, pharmacovigilance
- MeSH terms
- Clinical Trials as Topic, Humans, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Government Regulation, Drug-Related Side Effects and Adverse Reactions
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