Ethics review in compassionate use
نویسندگان
چکیده
منابع مشابه
Ethics review in compassionate use
BACKGROUND Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particula...
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Biomedical ethicists and clinical practitioners both champion the good of the patient, but sometimes their approaches diverge. The harmony of the ideal and the real is our utmost goal, but we often confront situations where theory falls apart in practice. A neonatal study performed by several noted institutions that is being audited by the US Office for Human Research Protections (OHRP) is a ca...
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Investigational medicinal products are available to patients through two pathways. The first is by participating in a clinical trial, the second as part of a compassionate use program, which is the use of an investigational medicinal product outside a clinical trial in patients with serious or life-threatening diseases for which no other treatment is available or expected to be effective. Usual...
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Is compassionate killing really psychologically impossible, as the Abhidhamma claims? Previously I discussed a Vinaya case that seemed to show the contrary. Reviewing my conclusions in the light of commentarial literature, Rupert Gethin disagreed and restated the Abhidhamma position that killing can never be motivated by compassion. This paper supports my original conclusions and argues further...
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BACKGROUND EU regulation 726/2004 authorises manufacturers to provide drugs to patients on a temporary basis when marketing authorisation sought centrally for the entire EU is still pending. Individual Member States retain the right to approve and implement such 'compassionate use' programmes which companies will usually provide for free. Nevertheless some companies have opted not to partake in...
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ژورنال
عنوان ژورنال: BMC Medicine
سال: 2017
ISSN: 1741-7015
DOI: 10.1186/s12916-017-0910-9