The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications
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 know...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1186/s40545-017-0100-3 |
| _version_ | 1797401328207527936 |
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| author | Eline M. Bunnik Nikkie Aarts Suzanne van de Vathorst |
| author_facet | Eline M. Bunnik Nikkie Aarts Suzanne van de Vathorst |
| author_sort | Eline M. Bunnik |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T02:08:30Z |
| format | Article |
| id | doaj.art-161a184a986a42fdab7d752b84401496 |
| institution | Directory Open Access Journal |
| issn | 2052-3211 |
| language | English |
| last_indexed | 2024-03-09T02:08:30Z |
| publishDate | 2017-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj.art-161a184a986a42fdab7d752b844014962023-12-07T15:28:01ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112017-12-0110110.1186/s40545-017-0100-312315029The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implicationsEline M. Bunnik0Nikkie Aarts1Suzanne van de Vathorst2Department of Medical Ethics and Philosophy of Medicine,Department of Medical Ethics and Philosophy of Medicine,Department of Medical Ethics and Philosophy of Medicine,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.http://dx.doi.org/10.1186/s40545-017-0100-3expanded accesscompassionate useinvestigational drugsethical issues |
| spellingShingle | Eline M. Bunnik Nikkie Aarts Suzanne van de Vathorst The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications Journal of Pharmaceutical Policy and Practice expanded access compassionate use investigational drugs ethical issues |
| title | The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications |
| title_full | The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications |
| title_fullStr | The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications |
| title_full_unstemmed | The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications |
| title_short | The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications |
| title_sort | changing landscape of expanded access to investigational drugs for patients with unmet medical needs ethical implications |
| topic | expanded access compassionate use investigational drugs ethical issues |
| url | http://dx.doi.org/10.1186/s40545-017-0100-3 |
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