ReviewClinical and translational science2020
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development.
Review in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 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
9 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Who should be included in first-in-human trials? A systematic review of reasons.Journal of translational medicine · 2025Pooled it
- Integration of healthy volunteers in early phase clinical trials with immuno-oncological compounds.Frontiers in oncology · 2022Pooled it
- The Effect of Food and the Proton Pump Inhibitor Rabeprazole on Binimetinib Pharmacokinetics in Healthy Participants.Clinical pharmacokinetics · 2026Trial
- Phase I crossover study of DNA-protein kinase inhibitor peposertib in healthy volunteers: Effect of food and pharmacokinetics of an oral suspension.Clinical and translational science · 2023Trial
- Single-Dose Pharmacokinetics and Tolerability of the Oral Epidermal Growth Factor Receptor Inhibitor Mobocertinib (TAK-788) in Healthy Volunteers: Low-Fat Meal Effect and Relative Bioavailability of 2 Capsule Products.Clinical pharmacology in drug development · 2021Trial
- Leveraging Healthy Volunteers for Anticancer Drug Clinical Pharmacology Studies: A Review Article Featuring Futibatinib as an Example.Clinical and translational science · 2026Review
- Utilization of Healthy Volunteers in Oncology Drug Development in Japan: A 10-Year Analysis of Approved Anticancer Agents (2014-2024).Clinical and translational science · 2026Review
- An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors.Clinical and translational science · 2026Article
- Asia-Inclusive Clinical Research and Development Enabled by Translational Science and Quantitative Clinical Pharmacology: Toward a Culture That Challenges the Status Quo.Clinical pharmacology and therapeutics · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Oncology drug development is among the most challenging of any therapeutic area, with first-in-human trials expected to deliver information on both safety and activity. Until recently, therapeutic approaches in oncology focused on cytotoxic chemotherapy agents, ruling out even the possibility of enrolling normal healthy volunteers (NHVs) in clinical trials due to safety considerations. The emergence of noncytotoxic modalities, including molecularly targeted agents with more favorable safety profiles, however, has led to increasing numbers of clinical pharmacology studies of these agents being conducted in NHVs. Beyond rapid enrollment and cost savings, there are other advantages of conducting specific types of studies in NHVs with the goal of more appropriate dosing decisions in certain subsets of the intended patient populations, allowing for enrollment of such patients in therapeutic trials from which they might otherwise have been excluded. Nevertheless, the decision must be carefully weighed against potential disadvantages, and although the considerations surrounding conduct of clinical trials using NHVs are generally well-defined in most other therapeutic areas, they are less well-defined in oncology.
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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.