Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analyses. There is much interest in quantifying regulatory approaches to benefit and risk. In this work, the use of a quantitative benefit risk analysis was applied to regulatory decision-making about new drugs to treat advanced Non-Small Cell Lung Cancer (NSCLC). Benefits and risks associated with twenty FDA decisions associated with a set of candidate treatments submitted between 2003 and 2015 were analyzed. For benefit analysis, the median overall survival (OS) was used where available. When not available, OS was estimated based on overall response rate (ORR) or progression free survival (PFS). Risks were analyzed based on magnitude (or severity) of harm and likelihood of occurrence. Additionally, a sensitivity analysis was explored to demonstrate analysis of systematic uncertainty. FDA approval decision outcomes considered were found to be consistent with the benefit-risk logic. This article is protected by copyright. All rights reserved.
Pharmacology, Toxicology and Pharmaceutical Science
2
9%
Mathematics
2
9%
Philosophy
1
5%
Nursing and Health Professions
1
5%
Other
2
9%
Unknown
9
41%
Attention Score in Context
Attention Score in Context
This research output has an Altmetric Attention Score of 1. 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 September 2016.
All research outputs
#22,029,081
of 24,577,646 outputs
Outputs from Clinical Pharmacology & Therapeutics
#4,216
of 4,386 outputs
Outputs of similar age
#280,589
of 322,297 outputs
Outputs of similar age from Clinical Pharmacology & Therapeutics
#45
of 45 outputs
Altmetric has tracked 24,577,646 research outputs across all sources so far. This one is in the 1st percentile – i.e., 1% of other outputs scored the same or lower than it.
So far Altmetric has tracked 4,386 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 8.9. This one is in the 1st percentile – i.e., 1% 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 322,297 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 45 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.
