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Benefits, challenges and obstacles of adaptive clinical trial designs

Overview of attention for article published in Orphanet Journal of Rare Diseases, January 2011
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About this Attention Score

  • Good Attention Score compared to outputs of the same age (73rd percentile)
  • Above-average Attention Score compared to outputs of the same age and source (51st percentile)

Mentioned by

policy
1 policy source
twitter
2 tweeters

Citations

dimensions_citation
36 Dimensions

Readers on

mendeley
83 Mendeley
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Title
Benefits, challenges and obstacles of adaptive clinical trial designs
Published in
Orphanet Journal of Rare Diseases, January 2011
DOI 10.1186/1750-1172-6-79
Pubmed ID
Authors

Shein-Chung Chow, Ralph Corey

Abstract

In recent years, the use of adaptive design methods in pharmaceutical/clinical research and development has become popular due to its flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation. The flexibility and efficiency, however, increase the risk of operational biases with resulting decrease in the accuracy and reliability for assessing the treatment effect of the test treatment under investigation. In its recent draft guidance, the United States Food and Drug Administration (FDA) expresses regulatory concern of controlling the overall type I error rate at a pre-specified level of significance for a clinical trial utilizing adaptive design. The FDA classifies adaptive designs into categories of well-understood and less well-understood designs. For those less well-understood adaptive designs such as adaptive dose finding designs and two-stage phase I/II (or phase II/III) seamless adaptive designs, statistical methods are not well established and hence should be used with caution. In practice, misuse of adaptive design methods in clinical trials is a concern to both clinical scientists and regulatory agencies. It is suggested that the escalating momentum for the use of adaptive design methods in clinical trials be slowed in order to allow time for development of appropriate statistical methodologies.

Twitter Demographics

The data shown below were collected from the profiles of 2 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 83 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Netherlands 1 1%
Norway 1 1%
India 1 1%
United Kingdom 1 1%
United States 1 1%
Unknown 78 94%

Demographic breakdown

Readers by professional status Count As %
Researcher 16 19%
Student > Ph. D. Student 16 19%
Student > Master 13 16%
Other 9 11%
Professor > Associate Professor 7 8%
Other 18 22%
Unknown 4 5%
Readers by discipline Count As %
Medicine and Dentistry 33 40%
Agricultural and Biological Sciences 9 11%
Pharmacology, Toxicology and Pharmaceutical Science 8 10%
Mathematics 7 8%
Chemistry 4 5%
Other 15 18%
Unknown 7 8%

Attention Score in Context

This research output has an Altmetric Attention Score of 4. 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 01 January 2017.
All research outputs
#4,294,306
of 15,115,606 outputs
Outputs from Orphanet Journal of Rare Diseases
#565
of 1,623 outputs
Outputs of similar age
#55,126
of 213,628 outputs
Outputs of similar age from Orphanet Journal of Rare Diseases
#18
of 39 outputs
Altmetric has tracked 15,115,606 research outputs across all sources so far. This one has received more attention than most of these and is in the 71st percentile.
So far Altmetric has tracked 1,623 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.3. This one has gotten more attention than average, scoring higher than 64% 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 213,628 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 73% of its contemporaries.
We're also able to compare this research output to 39 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 51% of its contemporaries.