| Title |
Expanding Patient Access to Investigational New Drugs Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies
|
|---|---|
| Published in |
JACC: Basic to Translational Science, June 2018
|
| DOI | 10.1016/j.jacbts.2018.02.001 |
| Pubmed ID | |
| Authors |
Gail A. Van Norman |
| Abstract |
Individual patients with life-threatening or severely debilitating diseases can petition the U.S. Food and Drug Administration (FDA) through their physicians to have expanded access (EA) to drugs that are in clinical trials but have not reached full FDA approval (the "single-patient" investigational new drug [IND] application). Additionally, recent state and federal laws-so-called "right to try legislation"-allow patients to approach drug companies directly for access prior to FDA approval. While these pathways provide potential access for individual patients to investigational drugs, different EA pathways permit entire groups of certain patients to access investigational drugs prior to FDA approval. This review focuses on special categories of EA INDs intended for multiple patients-the intermediate-group IND and the widespread-treatment IND-as well as emergency authorization for use of investigational drugs and biological products (e.g., vaccines) in public health emergencies. |
X Demographics
The data shown below were collected from the profiles of 2 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 | 2 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 50% |
| Science communicators (journalists, bloggers, editors) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 28 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 28 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 9 | 32% |
| Researcher | 4 | 14% |
| Student > Ph. D. Student | 3 | 11% |
| Other | 1 | 4% |
| Unknown | 11 | 39% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 5 | 18% |
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 14% |
| Agricultural and Biological Sciences | 3 | 11% |
| Nursing and Health Professions | 2 | 7% |
| Arts and Humanities | 1 | 4% |
| Other | 2 | 7% |
| Unknown | 11 | 39% |
Attention Score in Context
This research output has an Altmetric Attention Score of 28. 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 15 September 2021.
All research outputs
#1,363,859
of 25,385,509 outputs
Outputs from JACC: Basic to Translational Science
#117
of 799 outputs
Outputs of similar age
#28,793
of 342,237 outputs
Outputs of similar age from JACC: Basic to Translational Science
#7
of 23 outputs
Altmetric has tracked 25,385,509 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 799 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 20.4. This one has done well, scoring higher than 85% 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 342,237 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 91% of its contemporaries.
We're also able to compare this research output to 23 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 69% of its contemporaries.