Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions.

ABSTRACT: Oncology-associated adverse drug/device reactions can be fatal. Some clinicians who treat single patients with severe oncology-associated toxicities have researched case series and published this information. We investigated motivations and experiences of select individuals leading such efforts. Clinicians treating individual patients who developed oncology-associated serious adverse drug events were asked to participate. Inclusion criteria included having index patient information, reporting case series, and being collaborative with investigators from two National Institutes of Health funded pharmacovigilance networks. Thirty-minute interviews addressed investigational motivation, feedback from pharmaceutical manufacturers, FDA personnel, and academic leadership, and recommendations for i

SUBMITTER: Bennett CL 

PROVIDER: S-EPMC6668902 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature