ReviewNature reviews. Clinical oncology2017
Precision medicine needs randomized clinical trials.
Review in Nature reviews. Clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 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
33 citing papers in PubMed.
- Prescriptive Predictors of Mindfulness Ecological Momentary Intervention for Social Anxiety Disorder: Machine Learning Analysis of Randomized Controlled Trial Data.JMIR mental health · 2025Trial
- Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT): A Randomized Multicenter Phase II Trial.JCO precision oncology · 2021Trial
- Multi-omics-driven precision medicine.iMeta · 2026Review
- BIRTH: Bayesian integration of real-world data for trials with hybrid arms.BMC medical research methodology · 2026Article
- Exploring doctors' perspectives on precision medicine and AI in colorectal cancer: opportunities and challenges for the doctor-patient relationship.BMC medical informatics and decision making · 2025Article
- Enhancing the understanding of safety and the quality of patient care among medical and health sciences students in interprofessional climate: an interventional study.BMC health services research · 2025Article
- Bayesian Sequential Design for Identifying and Ranking Effective Patient Subgroups in Precision Medicine in the Case of Counting Outcome Data with Inflated Zeros.Journal of personalized medicine · 2023Article
- Review
- Pharmaco-proteogenomic characterization of liver cancer organoids for precision oncology.Science translational medicine · 2023Article
- Development of NS2B-NS3 protease inhibitor that impairs Zika virus replication.Virus research · 2023Article
- Bayesian modelling strategies for borrowing of information in randomised basket trials.Journal of the Royal Statistical Society. Series C, Applied statistics · 2022Article
- Challenges and the Evolving Landscape of Assessing Blood-Based PD-L1 Expression as a Biomarker for Anti-PD-(L)1 Immunotherapy.Biomedicines · 2022Review
- International consensus recommendations on key outcome measures for organ preservation after (chemo)radiotherapy in patients with rectal cancer.Nature reviews. Clinical oncology · 2021Review
- Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration.JAMA network open · 2021Article
- The next horizon in precision oncology: Proteogenomics to inform cancer diagnosis and treatment.Cell · 2021Review
- Pharmacogenomics Implementation and Hurdles to Overcome; In the Context of a Developing Country.Iranian journal of pharmaceutical research : IJPR · 2021Article
- Article
- Review
- Molecular Profiling-Based Precision Medicine in Cancer: A Review of Current Evidence and Challenges.Frontiers in oncology · 2020Review
- A Review of Perspectives on the Use of Randomization in Phase II Oncology Trials.Journal of the National Cancer Institute · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The advent of precision medicine has prompted profound changes in clinical cancer research, and the rising numbers of new therapeutic agents pose challenges in terms of the most appropriate trial designs and effects on the drug-approval process. In the past 5 years, some remarkably efficacious drugs have been approved based on evidence from uncontrolled phase I trials. We challenge the view that the expected benefits from new drugs are generally sufficient to forgo a randomized trial with patients assigned to a control arm (a regimen other than the experimental treatment). Relying on efficacy results from uncontrolled clinical trials can result in expedited drug approval, but the disadvantages of this practice must be taken into account. For example, the apparent improvements in outcomes observed in an early single-arm trial of a new therapy might reflect the prognostic nature of the target, rather than a true treatment effect. Moreover, the predictive role of biomarkers cannot be definitively ascertained without randomly assigning patients to a control arm. We discuss the need for such randomization to a true control in all phases of drug development and the role of companion biomarker testing. We propose that an increased use of randomization will facilitate a seamless transition between phases of drug and/or biomarker development.
Indexed as
Identifiers
28169302What 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.