title: Linking the human response to unplanned radiation and treatment to the nonhuman primate response to controlled radiation and treatment.
abstract: A key difficulty in developing countermeasures against radiation-induced health impairments is the clear lack of controlled clinical studies, due to the relatively low number of radiation victims worldwide. Instead, established and accepted animal models, as well as the recommendations of national and international expert panels and committees, are the main sources of information. Therefore, the development of countermeasures requires comparison of data from many sources and accumulation of information consistent with the U. S. Food and Drug Administration's "Animal Rule." A new approach is the comparative analysis of human data from the SEARCH (System for Evaluation and Archiving of Radiation Accidents based on Case Histories) database and data from nonhuman primate (NHP) animal model studies. The SEARCH database contains 824 clinical cases from 81 radiation accidents in 19 countries. This exceptional collection of clinical data from accidentally radiation-exposed persons is analyzed regarding clinical signs and symptoms of radiation-induced health impairments. To analyze the time course of radiation syndromes, clinical parameters common to the SEARCH and NHP databases have to be assigned into comparable categories of clinical severity for each species. The goal is to establish a method for comparison of human and NHP data, validate the NHP data as a surrogate for human efficacy/clinical studies, and open a way for the extraction of diagnostic and treatment methods for humans after radiation exposure according to relevant regulations.
authors.affiliation: *Bundeswehr Institute of Radiobiology affiliated to the University of Ulm, Munich, Germany; †University of Maryland, School of Medicine, Department of Radiation Oncology, Baltimore, MD; ‡U.S. Food and Drug Administration (FDA), Silver Spring, MD.
authors.forename: Harald
authors.initials: H
authors.lastname: Dörr
authors.forename: Andreas
authors.initials: A
authors.lastname: Lamkowski
authors.forename: Dieter H
authors.initials: DH
authors.lastname: Graessle
authors.forename: Alexander
authors.initials: A
authors.lastname: Bennett
authors.forename: Alla
authors.initials: A
authors.lastname: Shapiro
authors.forename: Ann M
authors.initials: AM
authors.lastname: Farese
authors.forename: Michael
authors.initials: M
authors.lastname: Garofalo
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: MacVittie
authors.forename: Viktor
authors.initials: V
authors.lastname: Meineke
mesh_terms: D000818:Animals; D016208:Databases, Factual; D004307:Dose-Response Relationship, Radiation; D004781:Environmental Exposure / Q000009:adverse effects; D006801:Humans; D011323:Primates; D011832:Radiation Injuries / Q000209:etiology* / Q000628:therapy*; D018788:Radioactive Hazard Release; D057170:Translational Research, Biomedical; D014916:Whole-Body Irradiation / Q000009:adverse effects