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Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

Overview of attention for article published in BMC Medical Research Methodology, June 2014
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Mentioned by

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1 Facebook page
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1 Google+ user

Citations

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12 Dimensions

Readers on

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30 Mendeley
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1 CiteULike
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Title
Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
Published in
BMC Medical Research Methodology, June 2014
DOI 10.1186/1471-2288-14-84
Pubmed ID
Authors

Ulrike Lorch, Martin O’Kane, Jorg Taubel

Abstract

This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective.

Mendeley readers

The data shown below were compiled from readership statistics for 30 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 1 3%
Unknown 29 97%

Demographic breakdown

Readers by professional status Count As %
Researcher 12 40%
Student > Ph. D. Student 6 20%
Other 5 17%
Student > Master 2 7%
Librarian 1 3%
Other 0 0%
Unknown 4 13%
Readers by discipline Count As %
Medicine and Dentistry 10 33%
Pharmacology, Toxicology and Pharmaceutical Science 4 13%
Mathematics 4 13%
Agricultural and Biological Sciences 3 10%
Psychology 1 3%
Other 2 7%
Unknown 6 20%

Attention Score in Context

This research output has an Altmetric Attention Score of 2. 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 24 July 2014.
All research outputs
#2,050,686
of 4,075,440 outputs
Outputs from BMC Medical Research Methodology
#290
of 506 outputs
Outputs of similar age
#47,045
of 101,841 outputs
Outputs of similar age from BMC Medical Research Methodology
#16
of 26 outputs
Altmetric has tracked 4,075,440 research outputs across all sources so far. This one is in the 44th percentile – i.e., 44% of other outputs scored the same or lower than it.
So far Altmetric has tracked 506 research outputs from this source. They receive a mean Attention Score of 4.4. This one is in the 36th percentile – i.e., 36% of its peers scored the same or lower than it.
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 101,841 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 47th percentile – i.e., 47% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 26 others from the same source and published within six weeks on either side of this one. This one is in the 38th percentile – i.e., 38% of its contemporaries scored the same or lower than it.