ArticleFrontiers in medicine2024
Gaps in the ethical governance of pharmaceutical clinical trials in Europe.
Article in Frontiers in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Review
- New pharmacotherapies for the erythropoietic protoporphyrias: an analysis of trial protocols from a patient perspective.Orphanet journal of rare diseases · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insufficient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP. To bridge these gaps, the paper suggests a shift from a prospective ethics review to a comprehensive end-to-end model of ethical governance.
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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.