title: Recommendations for Benchmarking Preclinical Studies of Nanomedicines.
abstract: Nanoparticle-based delivery systems provide new opportunities to overcome the limitations associated with traditional small-molecule drug therapy for cancer and to achieve both therapeutic and diagnostic functions in the same platform. Preclinical trials are generally designed to assess therapeutic potential and not to optimize the design of the delivery platform. Consequently, progress in developing design rules for cancer nanomedicines has been slow, hindering progress in the field. Despite the large number of preclinical trials, several factors restrict comparison and benchmarking of different platforms, including variability in experimental design, reporting of results, and the lack of quantitative data. To solve this problem, we review the variables involved in the design of preclinical trials and propose a protocol for benchmarking that we recommend be included in in vivo preclinical studies of drug-delivery platforms for cancer therapy. This strategy will contribute to building the scientific knowledge base that enables development of design rules and accelerates the translation of new technologies.
authors.affiliation: Institute for Nanobiotechnology, Johns Hopkins University, Baltimore, Maryland. Department of Materials Science and Engineering, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Charlene M
authors.initials: CM
authors.lastname: Dawidczyk
authors.affiliation: Institute for Nanobiotechnology, Johns Hopkins University, Baltimore, Maryland. Department of Materials Science and Engineering, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Luisa M
authors.initials: LM
authors.lastname: Russell
authors.affiliation: Institute for Nanobiotechnology, Johns Hopkins University, Baltimore, Maryland. Department of Materials Science and Engineering, Johns Hopkins University, Baltimore, Maryland. Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland. searson@jhu.edu.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Searson
mesh_terms: D000818:Animals; D019985:Benchmarking / Q000379:methods* / Q000592:standards; D002199:Capillary Permeability; D045744:Cell Line, Tumor; D004337:Drug Carriers; D016503:Drug Delivery Systems; D004354:Drug Screening Assays, Antitumor / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use; D008081:Liposomes; D051379:Mice; D008819:Mice, Nude; D016513:Mice, SCID; D053769:Nanocapsules / Q000008:administration & dosage; D050997:Nanomedicine / Q000379:methods* / Q000592:standards; D053758:Nanoparticles / Q000627:therapeutic use*; D009361:Neoplasm Invasiveness; D009369:Neoplasms / Q000098:blood supply / Q000188:drug therapy / Q000473:pathology; D012107:Research Design; D013047:Specific Pathogen-Free Organisms; D023041:Xenograft Model Antitumor Assays
chemical_list: D004337:Drug Carriers; D018796:Immunoconjugates; D008081:Liposomes; D053769:Nanocapsules