| Title |
FDA: Evidentiary standards for drug development and approval
|
|---|---|
| Published in |
Neurotherapeutics, July 2004
|
| DOI | 10.1602/neurorx.1.3.307 |
| Pubmed ID | |
| Authors |
Russell Katz |
| Abstract |
The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness. |
X Demographics
The data shown below were collected from the profiles of 11 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 3 | 27% |
| South Africa | 1 | 9% |
| United Kingdom | 1 | 9% |
| Spain | 1 | 9% |
| Unknown | 5 | 45% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 10 | 91% |
| Practitioners (doctors, other healthcare professionals) | 1 | 9% |
Mendeley readers
The data shown below were compiled from readership statistics for 88 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 1 | 1% |
| United States | 1 | 1% |
| Italy | 1 | 1% |
| Unknown | 85 | 97% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 17 | 19% |
| Other | 12 | 14% |
| Student > Ph. D. Student | 12 | 14% |
| Student > Master | 10 | 11% |
| Professor | 6 | 7% |
| Other | 13 | 15% |
| Unknown | 18 | 20% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 15% |
| Agricultural and Biological Sciences | 10 | 11% |
| Pharmacology, Toxicology and Pharmaceutical Science | 7 | 8% |
| Biochemistry, Genetics and Molecular Biology | 6 | 7% |
| Engineering | 5 | 6% |
| Other | 24 | 27% |
| Unknown | 23 | 26% |
Attention Score in Context
This research output has an Altmetric Attention Score of 27. 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 21 October 2022.
All research outputs
#1,438,523
of 25,373,627 outputs
Outputs from Neurotherapeutics
#108
of 1,308 outputs
Outputs of similar age
#1,621
of 59,041 outputs
Outputs of similar age from Neurotherapeutics
#1
of 5 outputs
Altmetric has tracked 25,373,627 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 94th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,308 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 18.2. This one has done particularly well, scoring higher than 91% 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 59,041 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 97% of its contemporaries.
We're also able to compare this research output to 5 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