ReviewMolecular therapy. Methods & clinical development2023
Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS.
Review in Molecular therapy. Methods & clinical development, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- AI for bioactive materials: From material design to biological applications.Bioactive materials · 2026Review
- Natural language processing to develop a standardized lexicon for precision medicine in oncology.Journal of managed care & specialty pharmacy · 2026Article
- Companion Diagnostics in Clinical Therapy: Current Applications and Future Directions.MedComm · 2026Review
- Milestone to Ensure Safety and Efficacy of Companion Diagnostic (CDx) That Support Treatment Decisions in Cancer Patients.Diagnostics (Basel, Switzerland) · 2026Review
- Unveiling Metabolic Signatures as Potential Biomarkers in Common Cancers: Insights from Lung, Breast, Colorectal, Liver, and Gastric Tumours.Biomolecules · 2025Review
- Fundamentals and Applications of Dual-Frequency Magnetic Particle Spectroscopy: Review for Biomedicine and Materials Characterization.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Review
- Polymerase Chain Reaction Chips for Biomarker Discovery and Validation in Drug Development.Micromachines · 2025Review
- From bench to bedside: translating mesenchymal stem cell therapies through preclinical and clinical evidence.Frontiers in bioengineering and biotechnology · 2025Review
- Insights into post-marketing clinical validation of companion diagnostics with reference to the FDA, EMA, PMDA, and MFDS.Molecular therapy. Methods & clinical development · 2024Review
- Companion Diagnostics (CDx) Based on Molecular Biology Techniques.Life (Basel, Switzerland) · 2024Review
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
Companion diagnostics (CDx), which is essential in precision medicine, is changing to a personalized treatment approach. CDx is a test that identifies patients who can benefit from a specific drug and those who experience side effects of drugs for safe and effective treatment. Conversely, when CDx has inadequate diagnostic performance or has not been adequately validated in a particular treatment, treatment prediction based on diagnostic results is not possible. Given the importance of CDx for the clinical use of biomarkers, strict regulation is essential. Regulators are providing more stringent regulations and are developing or revising guidelines. For example, the EU's In Vitro Diagnostic Regulation has defined CDx for the first time, raising awareness of the importance of CDx. However, if a new clinical performance test needs to be performed to meet the latest specifications or requirements for clinical data, problems such as securing clinical samples or institutions, cost, and time may occur. Therefore, an efficient clinical regulatory process may be required to meet stringent regulatory requirements. This study examines the need to strengthen the current clinical regulatory framework for CDx through an institutional comparison of regulatory agencies (FDA, EMA, and MFDS).
Indexed as
Identifiers
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.