ArticleJournal of biopharmaceutical statistics2017
Dose-finding designs for trials of molecularly targeted agents and immunotherapies.
Article in Journal of biopharmaceutical statistics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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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.
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Who cites it
15 citing papers in PubMed, 30 citations in OpenAlex.
- crm12comb: Phase I/II adaptive design for drug combinations based on CRM design through R.PloS one · 2025Article
- Article
- Phase I clinical trial designs in oncology: A systematic literature review from 2020 to 2022.Journal of clinical and translational science · 2024Article
- Determining drug dose in the era of targeted therapies: playing it (un)safe?Blood cancer journal · 2022Review
- The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension.Nature medicine · 2022Article
- Seamless phase I/II design for novel anticancer agents with competing disease progression.Statistics in medicine · 2021Article
- Operating characteristics are needed to properly evaluate the scientific validity of phase I protocols.Contemporary clinical trials · 2021Article
- Is more better? An analysis of toxicity and response outcomes from dose-finding clinical trials in cancer.BMC cancer · 2021Article
- Would the Recommended Dose Have Been Different Using Novel Dose-Finding Designs? Comparing Dose-Finding Designs in Published Trials.JCO precision oncology · 2021Article
- Designing Dose-Finding Phase I Clinical Trials: Top 10 Questions That Should Be Discussed With Your Statistician.JCO precision oncology · 2021Article
- Designing and evaluating dose-escalation studies made easy: The MoDEsT web app.Clinical trials (London, England) · 2020Article
- Incorporating patient-reported outcomes in dose-finding clinical trials.Statistics in medicine · 2020Article
- Practical considerations for the implementation of adaptive designs for oncology Phase I dose-finding trials.Future drug discovery · 2019Review
- How to design a dose-finding study using the continual reassessment method.BMC medical research methodology · 2019Article
- Design considerations for early-phase clinical trials of immune-oncology agents.Journal for immunotherapy of cancer · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
Recently, there has been a surge of early phase trials of molecularly targeted agents (MTAs) and immunotherapies. These new therapies have different toxicity profiles compared to cytotoxic therapies. MTAs can benefit from new trial designs that allow inclusion of low-grade toxicities, late-onset toxicities, addition of an efficacy endpoint, and flexibility in the specification of a target toxicity probability. To study the degree of adoption of these methods, we conducted a Web of Science search of articles published between 2008 and 2014 that describe phase 1 oncology trials. Trials were categorized based on the dose-finding design used and the type of drug studied. Out of 1,712 dose-finding trials that met our criteria, 1,591 (92.9%) utilized a rule-based design, and 92 (5.4%; range 2.3% in 2009 to 9.7% in 2014) utilized a model-based or novel design. Over half of the trials tested an MTA or immunotherapy. Among the MTA and immunotherapy trials, 5.8% used model-based methods, compared to 3.9% and 8.3% of the chemotherapy or radiotherapy trials, respectively. While the percentage of trials using novel dose-finding designs has tripled since 2007, the adoption of these designs continues to remain low.
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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.