Thomas W. LeBlanc, MD, MA, MHS and Arif H. Kamal, MD, MBA, MHS
Clinical trials should assess patients’ distress and test interventions to address it, just as they assess adverse events and test novel therapeutic agents.
AMA J Ethics. 2017;19(5):460-466. doi:
10.1001/journalofethics.2017.19.5.stas1-1705.
This process of developing EBM-based guidelines and applying them to clinical care highlights the tension between generating unbiased knowledge based on statistical aggregation and the application of this information to individual patients.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015;17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.
Nisha Quasba joins Ethics Talk to discuss her article, coauthored with Elliot Vice: “What Should Prescribers and Policy Makers Know About US Drug Importation?”