ReviewNature reviews. Clinical oncology2016
The changing landscape of phase I trials in oncology.
Review in Nature reviews. Clinical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 2 of them syntheses 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
41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- Integration of healthy volunteers in early phase clinical trials with immuno-oncological compounds.Frontiers in oncology · 2022Pooled it
- Trends of Phase I Clinical Trials of New Drugs in Mainland China Over the Past 10 Years (2011-2020).Frontiers in medicine · 2021Pooled it
- PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.Statistical methods in medical research · 2026Article
- International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Evolving phase I oncology trials in the precision medicine era: design, outcomes, and geographic access.ESMO real world data and digital oncology · 2026Article
- Use of supportive care services and advance care planning among early phase oncology clinical trial participants.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Dynamic clinical trial success rates for drugs in the 21st century.Nature communications · 2025Article
- A single centre experience of patients with rare cancers referred for early phase clinical trials.BMC cancer · 2025Article
- CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.EClinicalMedicine · 2025Article
- Navigating the complexities of drug development for inflammatory bowel disease.Nature reviews. Drug discovery · 2024Review
- A comparison of model-free phase I dose escalation designs for dual-agent combination therapies.Statistical methods in medical research · 2024Article
- Phase I clinical trial designs in oncology: A systematic literature review from 2020 to 2022.Journal of clinical and translational science · 2024Article
- Article
- Article
- Healthy volunteers in first-in-human oncology drug development for small molecules.British journal of clinical pharmacology · 2022Review
- Recruitment, outcomes, and toxicity trends in phase I oncology trials: Six-year experience in a large institution.Cancer reports (Hoboken, N.J.) · 2022Article
- Radiation therapy: An old dog learning new tricks.Methods in cell biology · 2022Article
- Characteristics of Early Phase Clinical Trials for Rare Cancers: Insights From Interviews With Stakeholders.Frontiers in pharmacology · 2022Article
- National Maintenance Cost for Precision Diagnostics Under the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (VALID) Act of 2020.JCO oncology practice · 2021Article
- Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.Cancer medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advances in our knowledge of the molecular pathogenesis of cancer have led to increased interest in molecularly targeted agents (MTAs), which target specific oncogenic drivers and are now a major focus of cancer drug development. MTAs differ from traditional cytotoxic agents in various aspects, including their toxicity profiles and the potential availability of predictive biomarkers of response. The landscape of phase I oncology trials is evolving to adapt to these novel therapies and to improve the efficiency of drug development. In this Review, we discuss new strategies used in phase I trial design, such as novel dose-escalation schemes to circumvent limitations of the classic 3 + 3 design and enable faster dose escalation and/or more-precise dose determinations using statistical modelling; improved selection of patients based on genetic or molecular biomarkers; pharmacokinetic and pharmacodynamic analyses; and the early evaluation of efficacy - in addition to safety. Indeed, new expedited approval pathways that can accelerate drug development require demonstration of efficacy in early phase trials. The application of molecular tumour profiling for matched therapy and the testing of drug combinations based on a strong biological rationale are also increasingly seen in phase I studies. Finally, the shift towards multi-institutional trials and centralized study management results in consequent implications for institutions and investigators. These issues are also highlighted herein.
Indexed as
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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.