Jennifer E. Miller, Joseph S. Ross, Kenneth I. Moch, Arthur L. Caplan
Abstract
We sought to determine the characteristics of "expanded access" and "compassionate use" programs registered in ClinicalTrials.gov and to determine the percentage of drugs provided through these programs that ultimately received FDA marketing approval.
We identified 398 expanded access and compassionate use programs (hereafter referred to as expanded access programs) registered on ClinicalTrials.gov. Industry funded 61% (n = 241) of programs individually or collaboratively, while NIH and the US Federal Government rarely funded programs (3% [n = 11] and 2% [n = 6], respectively). Most programs provided access to drugs (71% [n = 282]), 11% to biologics (n = 43), and 10% to medical devices (n = 40). These programs covered 460 unique conditions, the most common being HIV (n = 26), leukemia (22), and multiple myeloma (n = 14). Only 2% of programs reported results in ClinicalTrials.gov. Most programs (82%) were open to enrolling adults and seniors (n = 326). These programs provided access to 210 unique experimental drugs, of which 76% have received FDA approval.
Pharmacology, Toxicology and Pharmaceutical Science
13
22%
Medicine and Dentistry
10
17%
Agricultural and Biological Sciences
4
7%
Biochemistry, Genetics and Molecular Biology
3
5%
Nursing and Health Professions
2
3%
Other
13
22%
Unknown
15
25%
Attention Score in Context
Attention Score in Context
This research output has an Altmetric Attention Score of 446. 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 07 September 2018.
All research outputs
#63,553
of 25,728,855 outputs
Outputs from BMC Research Notes
#4
of 4,526 outputs
Outputs of similar age
#1,313
of 327,700 outputs
Outputs of similar age from BMC Research Notes
#1
of 152 outputs
Altmetric has tracked 25,728,855 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 4,526 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.3. This one has done particularly well, scoring higher than 99% 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 327,700 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 99% of its contemporaries.
We're also able to compare this research output to 152 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 99% of its contemporaries.
