| Title |
Expanding Patient Access to Investigational Drugs Single Patient Investigational New Drug and the “Right to Try”
|
|---|---|
| Published in |
JACC: Basic to Translational Science, May 2018
|
| DOI | 10.1016/j.jacbts.2017.11.007 |
| Pubmed ID | |
| Authors |
Gail A. Van Norman |
| Abstract |
With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic options are advocating for expanded access (EA) to investigational drugs prior to approval. Special investigational new drug (IND) application categories allow patients who meet specific criteria to receive treatment with non-approved drugs. The FDA approves over 99% of all single-patient INDs, providing emergency approval within hours, and non-emergency approval within an average of 4 days. "Right-to-try" laws passed in 38 states would allow patients to bypass FDA processes altogether, but contain controversial provisions that some claim risk more harm than benefit to desperate and vulnerable patients. This review focuses on FDA EA to non-approved drugs through a special category of IND-the single-patient IND-and "right-to-try" (R2T) access outside of the FDA. |
X Demographics
The data shown below were collected from the profiles of 9 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 | 4 | 44% |
| Chile | 1 | 11% |
| Netherlands | 1 | 11% |
| Spain | 1 | 11% |
| China | 1 | 11% |
| United Kingdom | 1 | 11% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 5 | 56% |
| Scientists | 2 | 22% |
| Science communicators (journalists, bloggers, editors) | 2 | 22% |
Mendeley readers
The data shown below were compiled from readership statistics for 37 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 37 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 12 | 32% |
| Student > Ph. D. Student | 6 | 16% |
| Researcher | 2 | 5% |
| Student > Bachelor | 2 | 5% |
| Lecturer > Senior Lecturer | 1 | 3% |
| Other | 2 | 5% |
| Unknown | 12 | 32% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 10 | 27% |
| Biochemistry, Genetics and Molecular Biology | 4 | 11% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 8% |
| Agricultural and Biological Sciences | 2 | 5% |
| Nursing and Health Professions | 1 | 3% |
| Other | 4 | 11% |
| Unknown | 13 | 35% |
Attention Score in Context
This research output has an Altmetric Attention Score of 4. 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 11 May 2018.
All research outputs
#7,359,319
of 25,382,440 outputs
Outputs from JACC: Basic to Translational Science
#480
of 799 outputs
Outputs of similar age
#120,527
of 344,275 outputs
Outputs of similar age from JACC: Basic to Translational Science
#16
of 22 outputs
Altmetric has tracked 25,382,440 research outputs across all sources so far. This one has received more attention than most of these and is in the 69th percentile.
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 is in the 38th percentile – i.e., 38% 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 344,275 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 64% of its contemporaries.
We're also able to compare this research output to 22 others from the same source and published within six weeks on either side of this one. This one is in the 27th percentile – i.e., 27% of its contemporaries scored the same or lower than it.