Evidence map›Paper›PMID 25742668›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2015

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

Heather B Edelblute, Jill A Fisher

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed.

  1. Article
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  3. Article
  4. Review
  5. Article
  6. "Death and Taxes": Why Financial Compensation for Research Participants is an Economic and Legal Risk.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023
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  7. Article
  8. Article
  9. Article
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  14. Sacrificial Labour: Social Inequality, Identity Work, and the Damaging Pursuit of Elusive Futures.Work, employment & society : a journal of the British Sociological Association · 2020
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2019
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Heather B EdelbluteUniversity of North Carolina at Chapel Hill, USA.
Jill A FisherUniversity of North Carolina at Chapel Hill, USA jill.fisher@unc.edu.

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
POPULATION STUDIEST32HD007168 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ELIZABETH A FRANKENBERG · 1985 to 2026
$13.8M
Carolina Population CenterR24HD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MORGAN, SAMUEL PHILIP · 2005 to 2014
$10.0M
Research Services CoreP2CHD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KAREN B GUZZO · 2015 to 2026
$9.6M
Healthy Volunteers as Model Organisms: Comparative Research Ethics and Policy for Phase I trialsR01GM099952 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FISHER, JILL A, WALKER, REBECCA · 2012 to 2020
$3.6M
NCATS NIH HHS 1UL1TR001111NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NICHD NIH HHS P2C HD050924NICHD NIH HHS R24 HD050924NICHD NIH HHS T32 HD007168NIGMS NIH HHS R01 GM099952NIGMS NIH HHS R01GM099952
6 · The paper itself

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.

Indexed as

Healthy VolunteersAdolescentAdultClinical Trials, Phase I as TopicFemaleHumansLongitudinal StudiesMaleMiddle AgedPatient SelectionRecordsUnited StatesYoung Adultbioethicsclinical trialshealthy volunteerspharmaceutical industryPhase Iprofessional guinea pigssociology

Identifiers

PMID25742668
PMCPMC4408988

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.