Using “Clinical Trial Diaries” to Track Patterns of Participation for Serial Healthy Volunteers in U.S. Phase I Studies

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Citation

Edelblute, Heather B. & Fisher, Jill A. (2015). 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, 10(1), 65-75. PMCID: PMC4408988

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.

URL

http://dx.doi.org/10.1177/1556264614568280

Reference Type

Journal Article

Year Published

2015

Journal Title

Journal of Empirical Research on Human Research Ethics

Author(s)

Edelblute, Heather B.
Fisher, Jill A.

PMCID

PMC4408988