ReviewNature reviews. Drug discovery2013
Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.
Review in Nature reviews. Drug discovery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
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
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- How are we evaluating the cost-effectiveness of companion biomarkers for targeted cancer therapies? A systematic review.BMC cancer · 2021Pooled it
- Trial
- FDA 2025 Cancer Drug Approvals: targeted therapy dominates.Exploration of targeted anti-tumor therapy · 2026Article
- Activatable companion theranostics for dual-modality imaging-escorted pyroptosis-propelled synergistic cancer therapy.Bioactive materials · 2025Article
- A DNA alteration and methylation co-detection method for clinical purpose.EMBO molecular medicine · 2025Article
- Companion Tests and Personalized Cancer Therapy: Reaching a Glass Ceiling.International journal of molecular sciences · 2024Review
- Imaging-guided companion diagnostics in radiotherapy by monitoring APE1 activity with afterglow and MRI imaging.Nature communications · 2024Article
- A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design.Statistics in biopharmaceutical research · 2024Article
- Reply to M. Younes.JCO precision oncology · 2023Article
- Novel Clinical Trial Designs in Neuro-Oncology.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Changes in Companion Diagnostic Labelling: Implementation of FDA's April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups.Therapeutic innovation & regulatory science · 2022Review
- Benefits of functional assays in personalized cancer medicine: more than just a proof-of-concept.Theranostics · 2021Review
- Challenges and approaches to implementing master/basket trials in oncology.Blood advances · 2019Article
- Annotation and detection of drug effects in text for pharmacovigilance.Journal of cheminformatics · 2018Article
- Integrative omics analyses broaden treatment targets in human cancer.Genome medicine · 2018Article
- CD8+ T cell infiltration in breast and colon cancer: A histologic and statistical analysis.PloS one · 2018Article
- Challenges in translational drug research in neuropathic and inflammatory pain: the prerequisites for a new paradigm.European journal of clinical pharmacology · 2017Review
- Molecular classification of tissue from a transformed non-Hogkin's lymphoma case with unexpected long-time remission.Experimental hematology & oncology · 2017Article
- Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov.Genetics in medicine : official journal of the American College of Medical Genetics · 2016Article
- Opportunities and Challenges for Drug Development: Public-Private Partnerships, Adaptive Designs and Big Data.Frontiers in pharmacology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As diagnostic tests become increasingly important for optimizing the use of drugs to treat cancers, the co-development of a targeted therapy and its companion diagnostic test is becoming more prevalent and necessary. In July 2011, the US Food and Drug Administration released a draft guidance that gave the agency's formal definition of companion diagnostics and introduced a drug-diagnostic co-development process for gaining regulatory approval. Here, we identify areas of drug-diagnostic co-development that were either not covered by the guidance or that would benefit from increased granularity, including how to determine when clinical studies should be limited to biomarker-positive patients, defining the diagnostically selected patient population in which to use a companion diagnostic, and defining and clinically validating a biomarker signature for assays that use more than one biomarker. We propose potential approaches that sponsors could use to deal with these challenges and provide strategies to help guide the future co-development of drugs and diagnostics.
Indexed as
Identifiers
24008432What 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.