Literature DB >> 30296882

Healthy Volunteers' Perceptions of the Benefits of Their Participation in Phase I Clinical Trials.

Jill A Fisher1, Lisa McManus1,2, Megan M Wood1, Marci D Cottingham3, Julianne M Kalbaugh1, Torin Monahan1, Rebecca L Walker1.   

Abstract

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 interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants' sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants' perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

Entities:  

Keywords:  benefit perception; demographic differences; economic motivation; healthy volunteers; phase I clinical trial; serial participation

Mesh:

Year:  2018        PMID: 30296882      PMCID: PMC6235676          DOI: 10.1177/1556264618804962

Source DB:  PubMed          Journal:  J Empir Res Hum Res Ethics        ISSN: 1556-2646            Impact factor:   1.742


  25 in total

1.  Challenging assumptions about minority participation in US clinical research.

Authors:  Jill A Fisher; Corey A Kalbaugh
Journal:  Am J Public Health       Date:  2011-10-20       Impact factor: 9.308

2.  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

3.  Concealment and fabrication by experienced research subjects.

Authors:  Eric G Devine; Megan E Waters; Megan Putnam; Caitlin Surprise; Katie O'Malley; Courtney Richambault; Rachel L Fishman; Clifford M Knapp; Elissa H Patterson; Ofra Sarid-Segal; Chris Streeter; Laurie Colanari; Domenic A Ciraulo
Journal:  Clin Trials       Date:  2013-07-18       Impact factor: 2.486

4.  Concealment and fabrication: the hidden price of payment for research participation?

Authors:  Neal W Dickert
Journal:  Clin Trials       Date:  2013       Impact factor: 2.486

5.  Exploiting a research underclass in phase 1 clinical trials.

Authors:  Carl Elliott; Roberto Abadie
Journal:  N Engl J Med       Date:  2008-05-29       Impact factor: 91.245

6.  Commentary on Grady et al.: Using poor, uninsured minorities to test the safety of experimental drugs.

Authors:  Carl Elliott
Journal:  Clin Trials       Date:  2017-07-27       Impact factor: 2.486

7.  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

8.  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

9.  Participation in clinical drug studies: motivations and barriers.

Authors:  K A Cunny; H W Miller
Journal:  Clin Ther       Date:  1994 Mar-Apr       Impact factor: 3.393

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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  9 in total

1.  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

2.  Speculating on Precarious Income: Finance Cultures and the Risky Strategies of Healthy Volunteers in Clinical Drug Trials.

Authors:  Jill A Fisher; Megan M Wood; Torin Monahan
Journal:  J Cult Econ       Date:  2020-12-21

3.  Informal professionalization of healthy participants in phase I clinical trials in Russia.

Authors:  Olga Zvonareva; Igor Pimenov; Natalia Kutishenko; Igor Mareev; Sergey Martsevich; Evgeny Kulikov
Journal:  Clin Trials       Date:  2019-10-24       Impact factor: 2.486

4.  Call to Action for Enhanced Equity and Inclusion in Cannabis Research.

Authors:  Renée Martin-Willett; L Cinnamon Bidwell
Journal:  Cannabis Cannabinoid Res       Date:  2021-04-15

5.  Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.

Authors:  Corey A Kalbaugh; Julianne M Kalbaugh; Lisa McManus; Jill A Fisher
Journal:  PLoS One       Date:  2021-09-07       Impact factor: 3.240

6.  Ethical considerations around volunteer payments in a malaria human infection study in Kenya: an embedded empirical ethics study.

Authors:  Primus Che Chi; Esther Awuor Owino; Irene Jao; Philip Bejon; Melissa Kapulu; Vicki Marsh; Dorcas Kamuya
Journal:  BMC Med Ethics       Date:  2022-04-20       Impact factor: 2.834

7.  Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic.

Authors:  Selena Russo; Marco Bani; Marco Terraneo; Valeria Quaglia; Giampaolo Nuvolati; Rebecca Cavaliere; Serena Capici; Marina Elena Cazzaniga; Maria Grazia Strepparava
Journal:  Eur J Clin Pharmacol       Date:  2022-09-14       Impact factor: 3.064

8.  Perception of clinical research among patients and healthy volunteers of clinical trials.

Authors:  Felix Bergmann; Peter Matzneller; Maria Weber; Lusine Yeghiazaryan; Thorsten Fuereder; Thomas Weber; Markus Zeitlinger
Journal:  Eur J Clin Pharmacol       Date:  2022-07-27       Impact factor: 3.064

9.  Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders.

Authors:  Primus Che Chi; Esther Awuor Owino; Irene Jao; Fredrick Olewe; Bernhards Ogutu; Philip Bejon; Melissa Kapulu; Dorcas Kamuya; Vicki Marsh
Journal:  Trials       Date:  2021-07-26       Impact factor: 2.279

  9 in total

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