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Josephson, Filip

A5055039896 | I1297934274

Mayo Clinic

European Medicines Agency

Citations 2

Cancer Clinical Trials beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion

Statistics in Biopharmaceutical Research | July 25, 2022 | Volume: 15 | Issue: 2 | Pages: 444-449

10.1080/19466315.2022.2103181

Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials

Clinical Infectious Diseases | August 17, 2018 | Volume: 68 | Issue: 8 | Pages: 1420-1426

10.1093/cid/ciy696 | PMID 30137245

Abstract Despite advances in preventive strategies, cytomegalovirus (CMV) infection remains a major complication in solid organ and hematopoietic cell transplant recipients. CMV infection may fail to respond to commercially available antiviral therapies, with or without demonstrating genotypic mutation(s) known to be associated with resistance to these therapies. This lack of response has been termed “resistant/refractory CMV” and is a key focus of clinical trials of some investigational antiviral agents. To provide consistent criteria for future clinical trials and outcomes research, the CMV Resistance Working Group of the CMV Drug Development Forum (consisting of scientists, clinicians, regulatory officials, and industry representatives from the United States, Canada, and Europe) has undertaken establishing standardized consensus definitions of “resistant” and “refractory” CMV. These definitions have emerged from the Working Group’s review of the available virologic and clinical literature and will be subject to reassessment and modification based on results of future studies.