ReviewEuropean journal of clinical pharmacology2010
Healthy volunteers and early phases of clinical experimentation.
Review in European journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis.Trials · 2024Pooled it
- Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012Pooled it
- Incidental findings in UK healthy volunteers screened for a COVID-19 vaccine trial.Clinical and translational science · 2022Trial
- 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
- Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change.Frontiers in pharmacology · 2025Article
- 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
- Evaluation of factors associated with recruitment rates in early phase clinical trials based on the European Clinical Trials Register data.Clinical and translational science · 2023Article
- Automated Electrodermal Activity and Facial Expression Analysis for Continuous Pain Intensity Monitoring on the X-ITE Pain Database.Life (Basel, Switzerland) · 2023Article
- Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.BMC medicine · 2023Review
- Trace amine-associated receptor 1 (TAAR1) agonists for psychosis: protocol for a living systematic review and meta-analysis of human and non-human studies.Wellcome open research · 2023Article
- Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic.European journal of clinical pharmacology · 2022Article
- The ethical anatomy of payment for research participants.Medicine, health care, and philosophy · 2022Article
- Gendered Logics of Biomedical Research: Women in U.S. Phase I Clinical Trials.Social problems · 2022Article
- The use of GA-RxODE (Genetics Algorithms and Running simulations from Ordinary Differential Equations-based model) method to optimize bioequivalence studies.Pharmacology research & perspectives · 2021Review
- Normative Values for the Unsupported Upper Limb Exercise Test and 6-Minute Pegboard and Ring Test in Healthy Canadian Adults.Physiotherapy Canada. Physiotherapie Canada · 2020Article
- Double-strand breaks in lymphocyte DNA of humans exposed to [EJNMMI research · 2020Article
- Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials.BMJ open · 2019Article
- Reviewing the role of healthy volunteer studies in drug development.Journal of translational medicine · 2018Review
- Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research.Clinical trials (London, England) · 2017Article
- Unveiling changes in the landscape of patient populations in cancer early drug development.Oncotarget · 2017Review
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 main goal of early phase trials is to gain knowledge about the clinical suitability of novel compounds, without pursuing specific therapeutic purposes. Healthy volunteers usually represent the ideal model for conducting phase I clinical trials, in order to investigate pharmacokinetics and pharmacodynamics as well as to document safety and tolerability without interference by concomitant pathological conditions. The increasing cost of novel drug development, in conjunction with ethical considerations, has fostered a new procedure for first-in-man trials, designated as "phase 0," which is conducted very early on a limited number of healthy volunteers who are exposed to low drug levels. The present review discusses issues concerning the enrollment of healthy volunteers in the early phase of drug development from different points of view, with some focus on the Italian experience. From the ethical standpoint, much discussion revolves around payments to healthy volunteers. Most authors agree that an adequate remuneration must be provided to healthy subjects, while avoiding coercion and excessive psychological pressure. Pending the lack of international and national guidelines, our center for clinical drug experimentation has implemented an operative procedure to estimate payments for healthy volunteers based on specific items, including restriction, time spent, discomfort, and risk. Other unresolved issues about the recruitment of healthy volunteers are represented by the lack of international consensus on the definition of healthy status and the need for guidelines about advertisement on clinical trials addressed to potential participants.
Indexed as
Identifiers
20461363What 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.