Expanded access

Article summary

Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate access, named-patient access, temporary authorization for use, cohort access, and pre-approval access. In general, the person and their doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicine's regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit. In some countries the government will pay for the drug or device, but in many countries the person must pay for the drug or device, as well as medical services necessary to receive it. In the US, compassionate use started with the provision of investigational medicine to certain patients in the late 1970s, and a formal program was established in 1987 in response to HIV/AIDS patients requesting access to drugs in development.…

Key claims

1. date of death: 2016 — source: Wikipedia · confidence 0.95
2. date of establishment: 1987 — source: Wikipedia · confidence 0.95
3. date of establishment: 2014 — source: Wikipedia · confidence 0.95
4. date of establishment: 1978 — source: Wikipedia · confidence 0.95

Discussion questions

1. Summarise the article in your own words. Which single claim would you verify first, and why?
2. The record states that the date of death is "2016". What evidence would count against this claim?
3. The record states that the date of establishment is "1987". What evidence would count against this claim?
4. The record states that the date of establishment is "2014". What evidence would count against this claim?
5. The record states that the date of establishment is "1978". What evidence would count against this claim?
6. Which claim in this article is most likely to be revised as the sources update? How would you check its current status?
7. If two sources disagreed about one of these facts, what would you need in order to trust one over the other?

Bibliography

1. Wikipedia https://en.wikipedia.org/w/index.php?oldid=1370734149