Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

Walker, Rebecca; Cottingham, Marci D.; Fisher, Jill A.

doi:10.1093/jmp/jhx033

Cited by 30 publications

(34 citation statements)

References 49 publications

(56 reference statements)

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“…If, however, they pay too little, there are concerns about exploitation (Philips 2011). We have argued elsewhere that there are important ethical issues in Phase I trials beyond those of compensation amounts (Walker, Cottingham, and Fisher 2018). 2 We withdrew two participants from our study when it was discovered that the same person enrolled twice, giving us different data.…”

Section: Resultsmentioning

confidence: 99%

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Williams

Fisher

2018

Sociological Inquiry

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This article develops the concept of temporal total institutions to describe how and why individuals voluntarily submit to highly-controlled and often dehumanizing environments. We focus empirically on Phase I clinical trials, which offer compensation to healthy people in exchange for testing investigational pharmaceuticals. Analyzing the experiences of 67 U.S. healthy volunteers, we illustrate how comparisons between Phase I trials and prison are salient to participants as they reflect on their confinement in research facilities and their interactions with other participants and research staff. We argue that conditions of contemporary economic insecurity and/or poverty facilitate the existence of coercive temporal total institutions by undermining voluntariness. Phase I clinics take advantage of the steady supply of individuals who will submit to the organization’s demands out of hope that the income gained will be transformative for their lives.

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Section: Resultsmentioning

confidence: 99%

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Williams

Fisher

2018

Sociological Inquiry

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“…Phase 1 trial participants are typically healthy volunteers who pass health screenings and have no identi able medical conditions related to the investigative drugs [2]. Additionally, because these volunteers are in "good health", they gain no direct medical bene t from research participation; also, they are typically recurring participants enrolling serially in phase 1 trials [19]. The main purpose for executing phase 1 trials is to evaluate a drug´s safety, with a low risk of originating numerous and/or severe AEs in unaffected parties.…”

Section: Discussionmentioning

confidence: 99%

Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials

Muñoz‐Villegas

Navarro-Sánchez

Sánchez‐Ríos

et al. 2020

Preprint

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Background: The purpose of this study was to evaluate the safety and tolerability profile of drugs used for treating common eye disorders when applied to normal healthy volunteers (NHV) as explored in phase 1 trials. Methods: A total of 166 NHV were identified in six phase 1 trials. These included the exposure to lubricant (n=88), hypotensive (n=48) or antibiotic (n=30) ophthalmic drugs, examined in a retrospective analysis. The primary endpoints were visual comfort, assessed by the ocular comfort index (OCI); and safety, evaluated through laboratory evaluations, vital signs, visual acuity (VA), intraocular pressure (IOP), lissamine green and fluorescein staining, conjunctival hyperemia, chemosis, and the incidence of adverse events (AE). Other measured parameters included discomfort (assessed by burning, itching and foreign body sensation) and conjunctival impression cytology. Results: Compared to baseline, 72.3%, 39.6% and 66.7% of participants (for lubricant, hypotensive and antibiotic treatments, respectively), improved their OCI score by their final visit (p=0.001). As expected for NHV, laboratory evaluations and vital signs were within normal ranges in 88% of NHV, with no significant differences observed between treatments. Similar results were found for VA, corneal and conjunctival staining and chemosis. IOP decreased significantly in the hypotensive agents group (p=0.001), trace to mild hyperemia was reported in 20.7%, 26% and 5.2% of NHV in each group (p=0.006). Additionally, lubricant and hypotensive investigational drugs (ID) had a lower risk of incidence of AE than approved drugs (AD) of these groups (OR 0.856, 95% CI [0.365, 1.999], and OR 0.636, 95% CI [0.096, 4.195], respectively). Meanwhile, on antibiotic drugs the risk for ID related AE was higher (OR 1.313, 95% CI [0.309, 5.583]). Conclusions: Phase 1 trials are important in order to ensure the safety and tolerability of ophthalmic medications. This study demonstrates that NHV do not face a significant risk of harm in these studies, since 98% of the reported AE were mild, and all AE were resolved by the end of the study in which they appeared. Furthermore, it was also demonstrated that the instillation of ID is as safe and tolerable as that of AD in NHV.Trial registration: The studies were registered at clinicaltrials.gov as follows: NCT04081610, NCT03524157, NCT03520348, NCT03966365, NCT03965052 and, NCT03519516.

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“…Healthy volunteers themselves sometimes reject the logic of undue inducement as a convenient fiction of drug companies in whose interest it is to undercompensate, and yet they also readily admit to participating in studies in some sense over their own objection due to the amount of compensation offered. 9 Specifically, some healthy volunteers have voiced reservations about what they see as unacceptable risks of participation but nonetheless feel that the money offered is too good to refuse. 10 Second, in spite of frequent conflation between coercion and undue inducement in research oversight, 11 typical bioethical understandings of coercion insist that, unlike with undue inducement, genuine offers cannot coerce.…”

Section: Structural Features Of Phase I Trials and Gaps In Ethics Ovementioning

confidence: 99%

Advancing Ethics and Policy for Healthy‐Volunteer Research through a Model‐Organism Framework

Fisher

Walker

2019

Ethics & Human Research

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Nonhuman animal research and phase I healthy-volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. By mobilizing a model-organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model-organism framework can enhance healthy volunteers’ welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.

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Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

Cited by 30 publications

References 49 publications

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions

Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials

Advancing Ethics and Policy for Healthy‐Volunteer Research through a Model‐Organism Framework

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