title: Drug-device trials for infectious diseases: CDRH perspective.
abstract: Assessing the performance of new diagnostic tests for infectious diseases has traditionally focused on comparing the new assay against a reference standard such as culture. In this paper, we suggest that clinical trial designs with both a diagnostic and therapeutic component may be necessary to evaluate the safety and effectiveness of nonmicrobiologically based assays, with a specific emphasis on the test/marker-stratified design. General design challenges for trials of infectious diseases that simultaneously study both diagnostic and therapeutic components (eg, both devices and drugs) are also discussed.
authors: Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Silver Spring, MD 20993-0002, USA. kristen.meier@fda.hhs.gov
authors: Kristen L
authors: KL
authors: Meier
authors: Steven
authors: S
authors: Gitterman
mesh_terms: D002986:Clinical Trials as Topic; D003141:Communicable Diseases / Q000175:diagnosis* / Q000188:drug therapy*; D057069:Diagnostic Test Approval; D017277:Drug Approval; D006801:Humans; D012107:Research Design