Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Feb;10(1):65-75.
doi: 10.1177/1556264614568280. Epub 2015 Jan 20.

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

Heather B Edelblute  1 , Jill A Fisher  2
Affiliations

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

Heather B Edelblute et al. J Empir Res Hum Res Ethics. 2015 Feb.

Abstract

Phase I testing of investigational drugs relies on healthy volunteers as research participants. Many U.S. healthy volunteers enroll repeatedly in clinical trials for the financial compensation. Serial participants are incentivized to ignore restrictions on their participation, and no centralized clinical trial registry prevents dual enrollment. Little is currently known about how healthy volunteers participate in studies over time, hampering the development of policies to protect this group. We detail a methodology developed as part of a longitudinal study to track in real-time healthy volunteers' Phase I participation. Illustrating these data through three case studies, we document how healthy volunteers use strategies, such as qualifying for studies at more than one clinic and traveling significant distances, to maximize their participation. Our findings suggest that "clinical trial diaries" can generate critical information about serial research participation and point to ethical issues unique to healthy volunteers' involvement in Phase I clinical trials.

Keywords: Phase I; bioethics; clinical trials; healthy volunteers; pharmaceutical industry; professional guinea pigs; sociology.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Design of clinical trial diary (CTD) system.
Figure 2
Figure 2
Clinical trial participation trajectories. Note. CVD = cardiovascular disease; COPD = chronic obstructive pulmonary disease.
See this image and copyright information in PMC

References

    1. Abadie R. The professional guinea pig: Big pharma and the risky world of human subjects. Duke University Press; Durham, NC: 2010.
    1. Almeida L, Azevedo B, Nunes T, Vaz-da-Silva M, Soares-da-Silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation? European Journal of Clinical Pharmacology. 2007;63:1085–1094. doi:10.1007/s00228-007-0368-3. - PubMed
    1. Camporesi S, McNamee MJ. Performance enhancement, elite athletes and anti doping governance: Comparing human guinea pigs in pharmaceutical research and professional sports. Philosophy, Ethics, and Humanities in Medicine. 2014;9(4):1–9. - PMC - PubMed
    1. Corrigan OP. “First in man”: The politics and ethics of women in clinical drug trials. Feminist Review. 2002;72:40–52.
    1. Devine EG, Waters ME, Putnam M, Surprise C, O'Malley K, Richambault C, Ciraulo DA. Concealment and fabrication by experienced research subjects. Clinical Trials. 2013;10:935–948. - PubMed

Publication types

LinkOut - more resources