Title |
The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications
|
---|---|
Published in |
Journal of Pharmaceutical Policy and Practice, February 2017
|
DOI | 10.1186/s40545-017-0100-3 |
Pubmed ID | |
Authors |
Eline M. Bunnik, Nikkie Aarts, Suzanne van de Vathorst |
Abstract |
When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic context. Worldwide, public and private parties are seeking to change this by informing patients and physicians about opportunities for expanded access and/or by facilitating its processes. When expanded access becomes available to larger groups of patients, ethical issues gain prominence, including informed consent, funding issues, disparities in access, and potential adverse effects on clinical drug development. Physicians, patients and policy-makers should not shift the responsibility to address these issues to pharmaceutical companies, but work together to resolve them. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 2 | 67% |
Australia | 1 | 33% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Science communicators (journalists, bloggers, editors) | 2 | 67% |
Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 32 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 10 | 31% |
Other | 3 | 9% |
Student > Doctoral Student | 3 | 9% |
Researcher | 3 | 9% |
Student > Ph. D. Student | 3 | 9% |
Other | 6 | 19% |
Unknown | 4 | 13% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 9 | 28% |
Pharmacology, Toxicology and Pharmaceutical Science | 6 | 19% |
Agricultural and Biological Sciences | 3 | 9% |
Social Sciences | 2 | 6% |
Biochemistry, Genetics and Molecular Biology | 1 | 3% |
Other | 6 | 19% |
Unknown | 5 | 16% |