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Design considerations for early-phase clinical trials of immune-oncology agents

Overview of attention for article published in Journal for Immunotherapy of Cancer, August 2018
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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 (88th percentile)

Mentioned by

news
1 news outlet
twitter
16 tweeters
facebook
1 Facebook page

Citations

dimensions_citation
38 Dimensions

Readers on

mendeley
104 Mendeley
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Title
Design considerations for early-phase clinical trials of immune-oncology agents
Published in
Journal for Immunotherapy of Cancer, August 2018
DOI 10.1186/s40425-018-0389-8
Pubmed ID
Authors

Nolan A. Wages, Cody Chiuzan, Katherine S. Panageas

Abstract

With numerous and fast approvals of different agents including immune checkpoint inhibitors, monoclonal antibodies, or chimeric antigen receptor (CAR) T-cell therapy, immunotherapy is now an established form of cancer treatment. These agents have demonstrated impressive clinical activity across many tumor types, but also revealed different toxicity profiles and mechanisms of action. The classic assumptions imposed by cytotoxic agents may no longer be applicable, requiring new strategies for dose selection and trial design. This main goal of this article is to summarize and highlight main challenges of early-phase study design of immunotherapies from a statistical perspective. We compared the underlying toxicity and efficacy assumptions of cytotoxic versus immune-oncology agents, proposed novel endpoints to be included in the dose-selection process, and reviewed design considerations to be considered for early-phase trials. When available, references to software and/or web-based applications were also provided to ease the implementation. Throughout the paper, concrete examples from completed (pembrolizumab, nivolumab) or ongoing trials were used to motivate the main ideas including recommendation of alternative designs. Further advances in the effectiveness of cancer immunotherapies will require new approaches that include redefining the optimal dose to be carried forward in later phases, incorporating additional endpoints in the dose selection process (PK, PD, immune-based biomarkers), developing personalized biomarker profiles, or testing drug combination therapies to improve efficacy and reduce toxicity.

Twitter Demographics

The data shown below were collected from the profiles of 16 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 104 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 104 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 27 26%
Student > Master 11 11%
Other 9 9%
Student > Bachelor 8 8%
Student > Ph. D. Student 8 8%
Other 9 9%
Unknown 32 31%
Readers by discipline Count As %
Medicine and Dentistry 22 21%
Biochemistry, Genetics and Molecular Biology 11 11%
Pharmacology, Toxicology and Pharmaceutical Science 9 9%
Agricultural and Biological Sciences 8 8%
Immunology and Microbiology 5 5%
Other 16 15%
Unknown 33 32%

Attention Score in Context

This research output has an Altmetric Attention Score of 20. 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 18 November 2020.
All research outputs
#1,329,776
of 19,441,086 outputs
Outputs from Journal for Immunotherapy of Cancer
#302
of 2,231 outputs
Outputs of similar age
#32,140
of 292,545 outputs
Outputs of similar age from Journal for Immunotherapy of Cancer
#1
of 1 outputs
Altmetric has tracked 19,441,086 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 93rd percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,231 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.0. This one has done well, scoring higher than 86% 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 292,545 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 88% 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