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Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis

Overview of attention for article published in BMC Medical Ethics, May 2015
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  • In the top 25% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (82nd percentile)

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11 tweeters
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2 Facebook pages

Citations

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20 Dimensions

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66 Mendeley
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Title
Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis
Published in
BMC Medical Ethics, May 2015
DOI 10.1186/s12910-015-0022-z
Pubmed ID
Authors

Laurie J Legocki, William J Meurer, Shirley Frederiksen, Roger J Lewis, Valerie L Durkalski, Donald A Berry, William G Barsan, Michael D Fetters

Abstract

In an adaptive clinical trial (ACT), key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts' views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions of clinical trial experts regarding their beliefs about ethical aspects of ACTs. We used a convergent, mixed-methods design employing a 22-item ACTs beliefs survey with visual analog scales and open-ended questions and mini-focus groups. We developed a coding scheme to conduct thematic searches of textual data, depicted responses to visual analog scales on box-plot diagrams, and integrated findings thematically. Fifty-three clinical trial experts from four constituent groups participated: academic biostatisticians (n = 5); consultant biostatisticians (n = 6); academic clinicians (n = 22); and other stakeholders including patient advocacy, National Institutes of Health, and U.S. Food and Drug Administration representatives (n = 20). The respondents recognized potential ethical benefits of ACTs, including a higher probability of receiving an effective intervention for participants, optimizing resource utilization, and accelerating treatment discovery. Ethical challenges voiced include developing procedures so trial participants can make informed decisions about taking part in ACTs and plausible, though unlikely risks of research personnel altering enrollment patterns. Clinical trial experts recognize ethical advantages but also pose potential ethical challenges of ACTs. The four constituencies differ in their weighing of ACT ethical considerations based on their professional vantage points. These data suggest further discussion about the ethics of ACTs is needed to facilitate ACT planning, design and conduct, and ultimately better allow planners to weigh ethical implications of competing trial designs.

Twitter Demographics

The data shown below were collected from the profiles of 11 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 66 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Ireland 1 2%
Brazil 1 2%
United Kingdom 1 2%
New Zealand 1 2%
United States 1 2%
Poland 1 2%
Unknown 60 91%

Demographic breakdown

Readers by professional status Count As %
Researcher 18 27%
Student > Ph. D. Student 17 26%
Student > Master 6 9%
Student > Doctoral Student 5 8%
Professor > Associate Professor 3 5%
Other 10 15%
Unknown 7 11%
Readers by discipline Count As %
Medicine and Dentistry 15 23%
Nursing and Health Professions 8 12%
Social Sciences 6 9%
Philosophy 4 6%
Psychology 4 6%
Other 18 27%
Unknown 11 17%

Attention Score in Context

This research output has an Altmetric Attention Score of 9. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 November 2019.
All research outputs
#2,253,984
of 14,969,364 outputs
Outputs from BMC Medical Ethics
#249
of 653 outputs
Outputs of similar age
#39,975
of 230,496 outputs
Outputs of similar age from BMC Medical Ethics
#1
of 1 outputs
Altmetric has tracked 14,969,364 research outputs across all sources so far. Compared to these this one has done well and is in the 84th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 653 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.8. This one has gotten more attention than average, scoring higher than 61% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 230,496 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 82% of its contemporaries.
We're also able to compare this research output to 1 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them