↓ Skip to main content

Innovative approaches to clinical development and trial design.

Overview of attention for article published in Annali dell'Istituto Superiore di Sanità, January 2011
Altmetric Badge

About this Attention Score

  • In the top 25% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#27 of 279)
  • High Attention Score compared to outputs of the same age (86th percentile)
  • High Attention Score compared to outputs of the same age and source (85th percentile)

Mentioned by

blogs
1 blog

Citations

dimensions_citation
11 Dimensions

Readers on

mendeley
2 Mendeley
You are seeing a free-to-access but limited selection of the activity Altmetric has collected about this research output. Click here to find out more.
Title
Innovative approaches to clinical development and trial design.
Published in
Annali dell'Istituto Superiore di Sanità, January 2011
DOI 10.4415/ann_11_01_03
Pubmed ID
Authors

John J Orloff, Donald Stanski

Abstract

Pharmaceutical innovation is increasingly risky, costly and at times inefficient, which has led to a decline in industry productivity. Despite the increased investment in R&D by the industry, the number of new molecular entities achieving marketing authorization is not increasing. Novel approaches to clinical development and trial design could have a key role in overcoming some of these challenges by improving efficiency and reducing attrition rates. The effectiveness of clinical development can be improved by adopting a more integrated model that increases flexibility and maximizes the use of accumulated knowledge. Central to this model of drug development are novel tools, including modelling and simulation, Bayesian methodologies, and adaptive designs, such as seamless adaptive designs and sample-size re-estimation methods. Applications of these methodologies to early- and late-stage drug development are described with some specific examples, along with advantages, challenges, and barriers to implementation. Because they are so flexible, these new trial designs require significant statistical analyses, simulations and logistical considerations to verify their operating characteristics, and therefore tend to require more time for the planning and protocol development phase. Greater awareness of the distinct advantages of innovative designs by regulators and sponsors are crucial to increasing the adoption of these modern tools.

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 2 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 3 150%
United Kingdom 1 50%
India 1 50%
Brazil 1 50%

Demographic breakdown

Readers by professional status Count As %
Researcher 11 550%
Student > Ph. D. Student 7 350%
Student > Bachelor 5 250%
Other 4 200%
Student > Doctoral Student 2 100%
Other 6 300%
Readers by discipline Count As %
Medicine and Dentistry 20 1000%
Agricultural and Biological Sciences 6 300%
Pharmacology, Toxicology and Pharmaceutical Science 3 150%
Business, Management and Accounting 2 100%
Engineering 2 100%
Other 1 50%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 9. 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 16 January 2014.
All research outputs
#3,799,858
of 25,377,790 outputs
Outputs from Annali dell'Istituto Superiore di Sanità
#27
of 279 outputs
Outputs of similar age
#22,161
of 190,502 outputs
Outputs of similar age from Annali dell'Istituto Superiore di Sanità
#3
of 20 outputs
Altmetric has tracked 25,377,790 research outputs across all sources so far. Compared to these this one has done well and is in the 83rd percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 279 research outputs from this source. They receive a mean Attention Score of 3.3. This one has done particularly well, scoring higher than 90% 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 190,502 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 86% of its contemporaries.
We're also able to compare this research output to 20 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 85% of its contemporaries.