Literature DB >> 25601069

Stopped hearts, amputated toes and NASA: contemporary legends among healthy volunteers in US phase I clinical trials.

Jill A Fisher1.   

Abstract

The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under controlled, in-patient conditions using healthy volunteers who are paid for their participation. To explore healthy volunteers' experiences in clinical trials, an ethnographic study was conducted at six in-patient phase I clinics in the USA. In addition to the observation of clinic activities (from informed consent procedures to dosing to blood draws), 268 semi-structured interviews were conducted, 33 with clinic staff and 235 with healthy volunteers. Drawing on this dataset, this article explores healthy volunteers' exchange of contemporary legends about phase I clinical trials. In addition to potentially scaring the listener and communicating distrust in the medical community, these incredible stories help participants cope with perceived stigma and establish a gradient of risk of trial participation, creating potential boundaries to their participation in medical research. The article argues that contemporary legends play a productive role in society, shaping how people view themselves and others and influencing their decisions about risky activities.
© 2015 The Author. Sociology of Health & Illness © 2015 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

Entities:  

Keywords:  clinical trials; contemporary legends; healthy volunteers; pharmaceuticals; phase I; safety

Mesh:

Substances:

Year:  2015        PMID: 25601069      PMCID: PMC4406236          DOI: 10.1111/1467-9566.12185

Source DB:  PubMed          Journal:  Sociol Health Illn        ISSN: 0141-9889


  12 in total

1.  Repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials?

Authors:  Carl L Tishler; Suzanne Bartholomae
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2.  Street smarts and urban myths: women, sex work, and the role of storytelling in risk reduction and rationalization.

Authors:  Brenda Roche; Alan Neaigus; Maureen Miller
Journal:  Med Anthropol Q       Date:  2005-06

3.  After the London tragedy, is it still possible to consider Phase I is safe?

Authors:  Michel Sibille; Yves Donazzolo; Franck Lecoz; Emmanuel Krupka
Journal:  Br J Clin Pharmacol       Date:  2006-07-03       Impact factor: 4.335

4.  Retelling urban legends.

Authors:  Jean E Fox Tree; Mary Susan Weldon
Journal:  Am J Psychol       Date:  2007

5.  Guinea-pigging: healthy human subjects for drug safety trials are in demand. But is it a living?

Authors:  Carl Elliott
Journal:  New Yorker       Date:  2008-01-07

6.  Attitudes and beliefs of African Americans toward participation in medical research.

Authors:  G Corbie-Smith; S B Thomas; M V Williams; S Moody-Ayers
Journal:  J Gen Intern Med       Date:  1999-09       Impact factor: 5.128

Review 7.  Why are African Americans under-represented in medical research studies? Impediments to participation.

Authors:  V L Shavers-Hornaday; C F Lynch; L F Burmeister; J C Torner
Journal:  Ethn Health       Date:  1997 Mar-Jun       Impact factor: 2.772

8.  A history of drug advertising: the evolving roles of consumers and consumer protection.

Authors:  Julie Donohue
Journal:  Milbank Q       Date:  2006       Impact factor: 4.911

9.  Why healthy subjects volunteer for phase I studies and how they perceive their participation?

Authors:  Luis Almeida; Benedita Azevedo; Teresa Nunes; Manuel Vaz-da-Silva; Patrício Soares-da-Silva
Journal:  Eur J Clin Pharmacol       Date:  2007-09-20       Impact factor: 2.953

10.  Balancing justice and autonomy in clinical research with healthy volunteers.

Authors:  N E Kass; R Myers; E J Fuchs; K A Carson; C Flexner
Journal:  Clin Pharmacol Ther       Date:  2007-04-04       Impact factor: 6.875

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  13 in total

1.  Response.

Authors:  Christine Grady
Journal:  Clin Trials       Date:  2017-07-14       Impact factor: 2.486

2.  Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.

Authors:  Lisa McManus; Arlene Davis; Rebecca L Forcier; Jill A Fisher
Journal:  J Law Med Ethics       Date:  2019-06       Impact factor: 1.718

3.  Using "clinical trial diaries" to track patterns of participation for serial healthy volunteers in U.S. phase I studies.

Authors:  Heather B Edelblute; Jill A Fisher
Journal:  J Empir Res Hum Res Ethics       Date:  2015-01-20       Impact factor: 1.742

4.  Strategies for Obtaining Access to Secretive or Guarded Organizations.

Authors:  Torin Monahan; Jill A Fisher
Journal:  J Contemp Ethnogr       Date:  2015-11-02

5.  Disadvantaged, Outnumbered, and Discouraged: Women's Experiences as Healthy Volunteers in U.S. Phase I Trials.

Authors:  Nupur Jain; Marci D Cottingham; Jill A Fisher
Journal:  Crit Public Health       Date:  2018-10-10

6.  Stakeholder views on participant selection for first-in-human trials in cancer nanomedicine.

Authors:  P Satalkar; B S Elger; D M Shaw
Journal:  Curr Oncol       Date:  2016-12-21       Impact factor: 3.677

7.  Risk and Emotion Among Healthy Volunteers in Clinical Trials.

Authors:  Marci D Cottingham; Jill A Fisher
Journal:  Soc Psychol Q       Date:  2016-07-29

8.  'I'm still a hustler': entrepreneurial responses to precarity by participants in phase I clinical trials.

Authors:  Torin Monahan; Jill A Fisher
Journal:  Econ Soc       Date:  2016-01-06

9.  Exceptional Risk: Healthy Volunteers' Perceptions of HIV/AIDS Clinical Trials.

Authors:  Marci D Cottingham; Julianne M Kalbaugh; Teresa Swezey; Jill A Fisher
Journal:  J Acquir Immune Defic Syndr       Date:  2018-10-01       Impact factor: 3.731

10.  Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research.

Authors:  Rebecca L Walker; Marci D Cottingham; Jill A Fisher
Journal:  J Med Philos       Date:  2018-01-12
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