ArticleBritish journal of clinical pharmacology2025
Sentinel dosing: A proposed algorithm to guide decision making on which cohorts in early phase clinical pharmacology trials should use this approach.
Article in British journal of clinical pharmacology, 2025. 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
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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.
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Who cites it
2 citing papers in PubMed.
- Unveiling clinical decision-making in pediatric surgery: how frontline staff perform and what shapes their skills.BMC medical education · 2026Article
- Sentinel dosing: A proposed algorithm to guide decision making on which cohorts in early phase clinical pharmacology trials should use this approach.British journal of clinical pharmacology · 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
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThe aim of this paper is to describe a proposal for an algorithm to guide decision making on which cohorts in early phase pharmacology trials should employ a sentinel approach, thereby standardising and harmonising practices, and improving decision making around sentinel dosing. Sentinel dosing is an approach described in EMA guidelines; however, the guidance does not provide detail on which cohorts or dose levels sentinel dosing applies.
methodsThis algorithm was designed using the expertise of senior scientific staff from the largest clinical research organisations in the Netherlands and after consultation with members of the ethics committee handling most early phase clinical drug trials in the Netherlands.
resultsThe algorithm describes a decision tree considering different aspects of the design of the trial, the IMP, and the prior knowledge of the IMP based on (pre)clinical data, to be used by investigators and regulators. Hereby the decision-making process on sentinel cohorts will be tailored to the specific IMP and information available. Starting in 2024, all three expert Phase 1 units that co-authored this paper are using the algorithm as guidance for decision-making on the implementation of sentinels in trials that are submitted to the EC Stichting BEBO.
conclusionThe algorithm provides further guidance and specification on when to implement sentinel dosing in early phase clinical trials, thereby creating a standardised and harmonised approach, which will improve the protection of subject safety and trial efficiency.
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Registered trials
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