ReviewClinical pharmacology and therapeutics2025
Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency.
Review in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Combination Strategies with HSP90 Inhibitors in Cancer Therapy: Mechanisms, Challenges, and Future Perspectives.Pharmaceuticals (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this. Relevant discussions between drug developers and regulators on the role of a biomarker in a specific drug development program are expected to take place during Scientific Advice (SA) procedures. SA procedures at the European Medicines Agency from January 1, 2018, to December 31, 2020, were systematically searched for methodological discussions around the use of predictive or prognostic biomarkers. The final analysis included 45 SA procedures for which key characteristics were summarized quantitatively. Selected methodological issues such as the cutoff selection of continuous biomarkers or study design considerations were elaborated in a qualitative summary. Our results identify commonly encountered points for discussion between drug developers and the European Medicines Agency for biomarker-informed patient selection and enrollment. Identified topics addressed during SA procedures include cutoff selection, study design, multiplicity control, and data-driven subgroup selection. The majority of the identified 45 SA procedures concern development programs in oncology. Addressing these issues upfront will allow for an improved dialogue between drug developers and regulators and support the drug development program and ultimately patient-centered access to medicines.
Indexed as
Identifiers
What Socratic 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 Socratic graph.