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Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

Overview of attention for article published in BMC Medicine, July 2017
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About this Attention Score

  • In the top 5% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (98th percentile)
  • High Attention Score compared to outputs of the same age and source (94th percentile)

Mentioned by

news
4 news outlets
blogs
4 blogs
policy
3 policy sources
twitter
168 X users

Citations

dimensions_citation
180 Dimensions

Readers on

mendeley
216 Mendeley
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Title
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
Published in
BMC Medicine, July 2017
DOI 10.1186/s12916-017-0902-9
Pubmed ID
Authors

Robert Kemp, Vinay Prasad

Abstract

Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to measure than clinically meaningful outcomes. The use of surrogates as an endpoint in clinical trials and basis for regulatory approval is common, and frequently exceeds the guidance given by regulatory bodies. In this article, we demonstrate that the use of surrogates in oncology is widespread and increasing. At the same time, the strength of association between the surrogates used and clinically meaningful outcomes is often unknown or weak. Attempts to validate surrogates are rarely undertaken. When this is done, validation relies on only a fraction of available data, and often concludes that the surrogate is poor. Post-marketing studies, designed to ensure drugs have meaningful benefits, are often not performed. Alternatively, if a drug fails to improve quality of life or overall survival, market authorization is rarely revoked. We suggest this reliance on surrogates, and the imprecision surrounding their acceptable use, means that numerous drugs are now approved based on small yet statistically significant increases in surrogates of questionable reliability. In turn, this means the benefits of many approved drugs are uncertain. This is an unacceptable situation for patients and professionals, as prior experience has shown that such uncertainty can be associated with significant harm. The use of surrogate outcomes should be limited to situations where a surrogate has demonstrated robust ability to predict meaningful benefits, or where cases are dire, rare or with few treatment options. In both cases, surrogates must be used only when continuing studies examining hard endpoints have been fully recruited.

X Demographics

X Demographics

The data shown below were collected from the profiles of 168 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 216 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 216 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 47 22%
Student > Master 25 12%
Other 22 10%
Student > Ph. D. Student 15 7%
Student > Doctoral Student 13 6%
Other 35 16%
Unknown 59 27%
Readers by discipline Count As %
Medicine and Dentistry 65 30%
Biochemistry, Genetics and Molecular Biology 19 9%
Agricultural and Biological Sciences 15 7%
Pharmacology, Toxicology and Pharmaceutical Science 13 6%
Mathematics 8 4%
Other 26 12%
Unknown 70 32%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 161. 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 06 November 2023.
All research outputs
#256,536
of 25,562,515 outputs
Outputs from BMC Medicine
#225
of 4,050 outputs
Outputs of similar age
#5,439
of 325,055 outputs
Outputs of similar age from BMC Medicine
#4
of 50 outputs
Altmetric has tracked 25,562,515 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 99th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 4,050 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 45.9. This one has done particularly well, scoring higher than 94% 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 325,055 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 98% of its contemporaries.
We're also able to compare this research output to 50 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 94% of its contemporaries.