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Reviewing the role of healthy volunteer studies in drug development
Background With the exception of genotoxic oncology drugs, first-in-human, Phase 1 clinical
studies of investigational drugs have traditionally been conducted in healthy volunteers …
studies of investigational drugs have traditionally been conducted in healthy volunteers …
Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy
Human infection challenge studies (HCS) involve intentionally infecting research
participants with pathogens (or other micro-organisms). There have been recent calls for …
participants with pathogens (or other micro-organisms). There have been recent calls for …
[КНИГА][B] Human challenge studies in endemic settings: ethical and regulatory issues
E Jamrozik, MJ Selgelid - 2021 - library.oapen.org
This open access book provides an extensive review of ethical and regulatory issues related
to human infection challenge studies, with a particular focus on the expansion of this type of …
to human infection challenge studies, with a particular focus on the expansion of this type of …
Consider drug efficacy before first-in-human trials
Consider drug efficacy before first-in-human trials | Nature Skip to main content Thank you for
visiting nature.com. You are using a browser version with limited support for CSS. To obtain the …
visiting nature.com. You are using a browser version with limited support for CSS. To obtain the …
Promoting ethical payment in human infection challenge studies
To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2,
we convened a multidisciplinary working group to address ethical questions regarding …
we convened a multidisciplinary working group to address ethical questions regarding …
Healthy volunteers' perceptions of the benefits of their participation in phase I clinical trials
Other than the financial motivations for enrolling in Phase I trials, research on how healthy
volunteers perceive the benefits of their trial participation is scant. Using qualitative …
volunteers perceive the benefits of their trial participation is scant. Using qualitative …
“Paid to endure”: Paid research participation, passivity, and the goods of work
E Malmqvist - The American Journal of Bioethics, 2019 - Taylor & Francis
A growing literature documents the existence of individuals who make a living by
participating in phase I clinical trials for money. Several scholars have noted that the …
participating in phase I clinical trials for money. Several scholars have noted that the …
Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective
LD Butler, P Guzzie-Peck, J Hartke… - Regulatory Toxicology …, 2017 - Elsevier
The transition from nonclinical to First-in-Human (FIH) testing is one of the most challenging
steps in drug development. In response to serious outcomes in a recent Phase 1 trial …
steps in drug development. In response to serious outcomes in a recent Phase 1 trial …
The impact of the global COVID‐19 pandemic on the conduct of clinical trials: Return to normalcy by considering the practical impact of a structured ethical analysis
MFJM Vissers, AF Cohen… - British Journal of …, 2021 - Wiley Online Library
During the outbreak of the COVID‐19 pandemic many clinical trials were abruptly halted.
Measures to contain the pandemic are currently taking effect and societies in general and …
Measures to contain the pandemic are currently taking effect and societies in general and …
Ethical criteria for improved human subject protections in phase I healthy volunteer trials
Phase I healthy volunteer trials test the safety and tolerability of investigational
pharmaceuticals. In them, participants are exposed to study‐drug risks without the possibility …
pharmaceuticals. In them, participants are exposed to study‐drug risks without the possibility …