ReviewJournal of translational medicine2018
Reviewing the role of healthy volunteer studies in drug development.
Review in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- 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
- A phase I trial of SON-1010, a tumor-targeted, interleukin-12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers.Frontiers in immunology · 2024Trial
- 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
- Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study.European journal of pain (London, England) · 2023Trial
- Modulation of premotor cortex response to sequence motor learning during escitalopram intake.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2021Trial
- Safety of healthy subjects in first-in-human multiple-dose studies: A pooled analysis.International journal of clinical pharmacology and therapeutics · 2021Trial
- Human Absorption, Metabolism, and Excretion (hAME) Mass Balance Studies in Patients With Cancer.Clinical and translational science · 2026Review
- Antimicrobial Pharmacokinetic and Pharmacodynamic Considerations in Special Populations: A Call to Action.Open forum infectious diseases · 2026Review
- Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022.Clinical and translational science · 2025Article
- Dose, Kidney Function, and a Drug-Excipient Interaction Impair Mycophenolate Mofetil Prodrug Activation in Kidney Transplant Recipients.European journal of drug metabolism and pharmacokinetics · 2025Observational
- Article
- Bayesian sequential monitoring strategies for trials of digestive cancer therapeutics.BMC medical research methodology · 2024Article
- Pooled analysis of routine safety parameters observed in healthy participants at baseline and following placebo administration in early phase clinical studies.Clinical and translational science · 2024Article
- Diversifying the research landscape: Assessing barriers to research for underrepresented populations in an online study of Parkinson's disease.Journal of clinical and translational science · 2024Article
- Mass balance, metabolism, and pharmacokinetics of [Frontiers in pharmacology · 2024Article
- Innovations, Opportunities, and Challenges for Predicting Alteration in Drug-Metabolizing Enzyme and Transporter Activity in Specific Populations.Drug metabolism and disposition: the biological fate of chemicals · 2023Article
- The Pharmacokinetics and Safety of Tucatinib in Volunteers with Hepatic Impairment.Clinical pharmacokinetics · 2022Article
- Physical Rehabilitation Programs for Bedridden Patients with Prolonged Immobility: A Scoping Review.International journal of environmental research and public health · 2022Article
- A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies.BMC veterinary research · 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
8 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundWith the exception of genotoxic oncology drugs, first-in-human, Phase 1 clinical studies of investigational drugs have traditionally been conducted in healthy volunteers (HVs). The primary goal of these studies is to investigate the pharmacokinetics and pharmacodynamics of a novel drug candidate, determine appropriate dosing, and document safety and tolerability. MAIN BODY: When tailored to specific study objectives, HV studies are beneficial to manufacturers and patients alike and can be applied to both non-oncology and oncology drug development. Enrollment of HVs not only increases study accrual rates for dose-escalation studies but also alleviates the ethical concern of enrolling patients with disease in a short-term study at subtherapeutic doses when other studies (e.g. Phase 2 or Phase 3 studies) may be more appropriate for the patient. The use of HVs in non-oncology Phase 1 clinical trials is relatively safe but nonetheless poses ethical challenges because of the potential risks to which HVs are exposed. In general, most adverse events associated with non-oncology drugs are mild in severity, and serious adverse events are rare, but examples of severe toxicity have been reported. The use of HVs in the clinical development of oncology drugs is more limited but is nonetheless useful for evaluating clinical pharmacology and establishing an appropriate starting dose for studies in cancer patients. During the development of oncology drugs, clinical pharmacology studies in HVs have been used to assess pharmacokinetics, drug metabolism, food effects, potential drug-drug interactions, effects of hepatic and renal impairment, and other pharmacologic parameters vital for clinical decision-making in oncology. Studies in HVs are also being used to evaluate biosimilars versus established anticancer biologic agents.
conclusionA thorough assessment of toxicity and pharmacology throughout the drug development process is critical to ensure the safety of HVs. With the appropriate safeguards, HVs will continue to play an important role in future drug development.
Indexed as
Identifiers
What Socratic 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 Socratic graph.