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Enhancing clinical evidence by proactively building quality into clinical trials

Overview of attention for article published in Clinical Trials, April 2016
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About this Attention Score

  • In the top 25% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (84th percentile)
  • Good Attention Score compared to outputs of the same age and source (71st percentile)

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88 Mendeley
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Title
Enhancing clinical evidence by proactively building quality into clinical trials
Published in
Clinical Trials, April 2016
DOI 10.1177/1740774516643491
Pubmed ID
Authors

Ann Meeker-O’Connell, Coleen Glessner, Mark Behm, Jean Mulinde, Nancy Roach, Fergus Sweeney, Pamela Tenaerts, Martin J Landray

Abstract

Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight. The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials ("quality-by-design"), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach. The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of active discussions incorporating the different perspectives within and external to an organization (e.g. clinical investigators, research site staff, and trial participants) in improving trial design. Workshop participants also recognized the value of focusing oversight on those aspects of the trial where errors would have a major impact on participant safety and reliability of results. Applying the Clinical Trials Transformation Initiative quality-by-design recommendations and principles should enable organizations to prioritize the most critical determinants of a trial's quality, identify non-essential activities that can be eliminated to streamline trial conduct and oversight, and formulate appropriate plans to define, avoid, mitigate, monitor, and address important errors.

X Demographics

X Demographics

The data shown below were collected from the profiles of 20 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 88 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 1 1%
Unknown 87 99%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 13 15%
Researcher 13 15%
Student > Master 11 13%
Other 10 11%
Student > Bachelor 8 9%
Other 16 18%
Unknown 17 19%
Readers by discipline Count As %
Medicine and Dentistry 18 20%
Pharmacology, Toxicology and Pharmaceutical Science 13 15%
Nursing and Health Professions 8 9%
Biochemistry, Genetics and Molecular Biology 4 5%
Social Sciences 3 3%
Other 20 23%
Unknown 22 25%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 12. 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 22 February 2021.
All research outputs
#2,816,703
of 23,758,334 outputs
Outputs from Clinical Trials
#143
of 889 outputs
Outputs of similar age
#45,148
of 300,972 outputs
Outputs of similar age from Clinical Trials
#3
of 7 outputs
Altmetric has tracked 23,758,334 research outputs across all sources so far. Compared to these this one has done well and is in the 88th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 889 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.1. This one has done well, scoring higher than 84% 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 300,972 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 84% of its contemporaries.
We're also able to compare this research output to 7 others from the same source and published within six weeks on either side of this one. This one has scored higher than 4 of them.