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Ethics review in compassionate use [PDF]
BMC Medicine, 2017 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 ...
Jan Borysowski +2 more
doaj +3 more sources
Voices in Bioethics, 2015 Earlier this month, Johnson & Johnson (J&J) announced that it will create an independent panel to review compassionate use requests and determine how the company should respond.[i] This announcement, which comes after high-profile social media campaigns ...
Pranav Aurora
doaj +2 more sources
Efficacy and safety of compassionate use for rare diseases: a scoping review from 1991 to 2022 [PDF]
Orphanet Journal of Rare Diseases, 2023 Background Compassionate use is a system that provides patients with expedited access to drugs which has not yet been approved, but currently in clinical trials.
Jiayu Wu +5 more
doaj +2 more sources
The economic impact of compassionate use of medicines [PDF]
BMC Health Services Research, 2021 Background Compassionate use programs (CUP) for medicines respond to the ethical imperative of providing access to medicines before marketing approval to patients not recruited in trials.
Claudio Jommi +4 more
doaj +6 more sources
Compassionate use of cell products
Revista Brasileira de Hematologia e Hemoterapia, 2013 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 ...
Gil Cunha de Santis +2 more
doaj +4 more sources
Applying real-world data from expanded-access (“compassionate use”) patients to drug development [PDF]
Journal of Clinical and Translational Science, 2023 Our drug development process has produced many life-saving medications, but patients experiencing rare diseases and similar conditions often are left with limited options for treatment.
June S. Wasser, David J. Greenblatt
doaj +2 more sources
Trends in compassionate use of medicinal products: Israel 2020–2024 [PDF]
Israel Journal of Health Policy ResearchBackground Compassionate use programs allow patients with life-threating and serious conditions to access investigational therapies when standard treatments are inadequate.
Eyal Schwartzberg +5 more
doaj +2 more sources
Compassionate use programs in Italy: ethical guidelines [PDF]
BMC Medical Ethics, 2018 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.
Ludovica De Panfilis +2 more
doaj +3 more sources
Compassionate Drug Use – Time Arising for a New Law in Bulgaria in the Era of COVID-19 [PDF]
Folia Medica, 2020 Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use.
Nigyar Dzhafer, Jannis V. Papathanasiou
doaj +3 more sources
Frontiers in Neurology, 2021 During a 1-year compassionate use program, 156 patients with migraine self-administered a monthly dose of erenumab 140 mg with a subcutaneous autoinjector.
Jean Schoenen +5 more
doaj +1 more source