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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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  • Good Attention Score compared to outputs of the same age (72nd percentile)
  • Above-average Attention Score compared to outputs of the same age and source (53rd percentile)

Mentioned by

policy
1 policy source
twitter
2 tweeters

Citations

dimensions_citation
38 Dimensions

Readers on

mendeley
89 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 In its recent draft guidance, the United States Food and Drug Administration (FDA) expresses regulatory concern of controlling the overall type I error rate at a pre-specified level of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 89 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 84 94%

Demographic breakdown

Readers by professional status Count As %
Researcher 17 19%
Student > Ph. D. Student 16 18%
Student > Master 15 17%
Other 9 10%
Student > Bachelor 8 9%
Other 19 21%
Unknown 5 6%
Readers by discipline Count As %
Medicine and Dentistry 34 38%
Agricultural and Biological Sciences 10 11%
Mathematics 8 9%
Pharmacology, Toxicology and Pharmaceutical Science 8 9%
Chemistry 5 6%
Other 16 18%
Unknown 8 9%

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
#5,107,997
of 17,358,590 outputs
Outputs from Orphanet Journal of Rare Diseases
#661
of 1,839 outputs
Outputs of similar age
#59,247
of 221,516 outputs
Outputs of similar age from Orphanet Journal of Rare Diseases
#21
of 43 outputs
Altmetric has tracked 17,358,590 research outputs across all sources so far. This one has received more attention than most of these and is in the 70th percentile.
So far Altmetric has tracked 1,839 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.5. This one has gotten more attention than average, scoring higher than 63% 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 221,516 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 72% of its contemporaries.
We're also able to compare this research output to 43 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 53% of its contemporaries.