Ethics review in compassionate use

J Borysowski, HJ Ehni, A Górski - BMC medicine, 2017 - Springer
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 …

Going “social” to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access

TK Mackey, VJ Schoenfeld - BMC medicine, 2016 - Springer
Social media is fundamentally altering how we access health information and make
decisions about medical treatment, including for terminally ill patients. This specifically …

The role of physicians in expanded access to investigational drugs: A mixed-methods study of physicians' views and experiences in the Netherlands

EM Bunnik, N Aarts - Journal of Bioethical Inquiry, 2021 - Springer
Treating physicians have key roles to play in expanded access to investigational drugs, by
identifying investigational treatment options, assessing the balance of risks and potential …

Physician perspectives on compassionate use in pediatric oncology

S Moerdler, L Zhang, E Gerasimov, C Zhu… - Pediatric Blood & …, 2019 - Wiley Online Library
Background Targeted cancer treatments are almost always first studied in adults, even when
there is a biologically plausible potential for efficacy in children. Through compassionate use …

Perspectives of academic oncologists about offering expanded access to investigational drugs

P Gould, T Salam, L Kimberly… - JAMA Network …, 2022 - jamanetwork.com
Importance The expanded access (EA) pathway permits patients to be treated with
investigational medical products outside clinical trials. Because cancer care is a common …

Use of real-world data for the research, development, and evaluation of oncology precision medicines

JRR Lewis, I Kerridge, W Lipworth - JCO precision oncology, 2017 - ascopubs.org
Although randomized controlled trials remain the scientific ideal for determining the efficacy
and safety of new treatments, they are sometimes insufficient to address the evidentiary …

[HTML][HTML] The compassionate use of drugs in palliative care for symptom control and ethical justifications for its use: A scoping review

IA Gouveia, P Reis-Pina - Ethics, Medicine and Public Health, 2023 - Elsevier
Introduction Compassionate use of drugs is becoming increasingly popular among
terminally ill patients who require palliative care and have exhausted all treatment options …

Coverage with evidence development and managed entry in the funding of personalized medicine: practical and ethical challenges for oncology

JRR Lewis, I Kerridge, W Lipworth - Journal of Clinical Oncology, 2015 - ascopubs.org
Personalized medicines hold promise for many diseases. However, demonstrating the
clinical efficacy and cost effectiveness of these medicines can be difficult. It is essential that …

An analysis of common ethical justifications for compassionate use programs for experimental drugs

K Raus - BMC medical ethics, 2016 - Springer
Background When a new intervention or drug is developed, this has to pass through various
phases of clinical testing before it achieves market approval, which can take many years …

Examining the ethics of clinical use of unproven interventions outside of clinical trials during the Ebola epidemic

SK Shah, D Wendler, M Danis - The American Journal of Bioethics, 2015 - Taylor & Francis
The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused
the deaths of over 6,000 people. Since there are no approved treatments or prevention …