منابع مشابه
Compassionate use of cell products
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...
متن کاملEthics 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...
متن کاملCompassionate use of orphan drugs
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...
متن کاملOn self-compassion and self-care in nursing: selfish or essential for compassionate care?
Compassionate care in nursing is increasingly an rnational concern. While the literature to date has ussed on redressing a compassion and care deficit oss the nursing discipline (Crawford et al., 2014; Dewar al., 2014; Scott, 2014), we suggest here that due sideration be given to its relationship to self-care and -compassion in nurses. After all, a deficit in these promises nurses’ therapeutic ...
متن کاملCompassionate use programs in Italy: ethical guidelines
BACKGROUND This article proposes a retrospective analysis of a compassionate use (CU), using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee (EC) following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific e...
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ژورنال
عنوان ژورنال: Journal of Clinical Oncology
سال: 2018
ISSN: 0732-183X,1527-7755
DOI: 10.1200/jco.18.00205