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

Journal of Empirical Research on Human Research Ethics : JERHRE
Heather B Edelblute, Jill A Fisher

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.

References

Nov 1, 2003·Perspectives in Biology and Medicine·Carl L Tishler, Suzanne Bartholomae
Jul 5, 2006·British Journal of Clinical Pharmacology·Michel SibilleEmmanuel Krupka
Apr 6, 2007·Clinical Pharmacology and Therapeutics·N E KassC Flexner
Sep 25, 2007·European Journal of Clinical Pharmacology·Luis AlmeidaPatrício Soares-da-Silva
Feb 24, 2009·Journal of Women's Health·Susan F Wood
Sep 28, 2010·Gender Medicine·Jill A Fisher, Lorna M Ronald
Mar 17, 2011·JAMA : the Journal of the American Medical Association·David B Resnik, Greg Koski
Oct 25, 2011·American Journal of Public Health·Jill A Fisher, Corey A Kalbaugh
May 23, 2012·Clinical Pharmacology and Therapeutics·E A Kupetsky-Rincon, W K Kraft
Jul 23, 2013·Clinical Trials : Journal of the Society for Clinical Trials·Eric G DevineDomenic A Ciraulo
Nov 30, 2013·Clinical Trials : Journal of the Society for Clinical Trials·Neal W Dickert
Jan 23, 2014·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Rebecca Dresser

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Citations

Jan 18, 2018·The Journal of Medicine and Philosophy·Rebecca L WalkerJill A Fisher
Sep 18, 2018·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Marci D CottinghamJill A Fisher
Oct 10, 2018·Journal of Empirical Research on Human Research Ethics : JERHRE·Jill A FisherRebecca L Walker
Jul 13, 2019·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Lisa McManusJill A Fisher
Oct 28, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Olga ZvonarevaEvgeny Kulikov
Oct 8, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Jill A Fisher
Sep 28, 2017·AJOB Empirical Bioethics·Laura Weiss Roberts, Jane Paik Kim
Dec 19, 2017·Health, Risk & Society·Marci D Cottingham, Jill A Fisher
May 21, 2020·Work, Employment & Society : a Journal of the British Sociological Association·Torin Monahan, Jill A Fisher
Dec 14, 2018·Sociological Inquiry·Quintin Williams, Jill A Fisher
Feb 13, 2019·Ethics & Human Research·Jill A Fisher, Rebecca L Walker
Aug 17, 2019·The American Journal of Bioethics : AJOB·Erik Malmqvist
Sep 5, 2017·Social Psychology Quarterly·Marci D Cottingham, Jill A Fisher
May 4, 2021·Clinical Trials : Journal of the Society for Clinical Trials·Jill A FisherRebecca L Walker
Sep 27, 2021·Sociology of Health & Illness·Natassia Brenman, Richard Milne

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Software Mentioned

clinicalRSVP
REDCap
Verified Trials

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