Working page for definitions

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literature references

Instructions: Copy the Example line below and change the name, file name, and description. Click "show preview" to make sure it looks right. The file link should be red. Click "save page". Click on the red link, which will take you to a page where you upload the file. Choose the source file from your computer. Please do not upload copyrighted material.The destination file name will be what it is called on the PhUSE server (which should be the same as the text after File: in the double brackets).

  1. Example: Lauren Mihalcik, Media:RasH2 historical control data.pdf, a compilation of historical control data for the RasH2 model system (just a placeholder, not necessarily the kind of data we're looking for)
  2. Joyce Zandee, Media:Lies, Damn Lies, and Reference Intervals (Hall).pdf, an editorial on the value of historical control reference ranges for Clin Path data (or the lack thereof), plus responses from other scientists
  3. Joyce Zandee, Media:Incidences and Range of Spontaneous Findings in Control Cynomolgus Monkeys Used in Toxicity Studies (Chamanza et al).pdf, the results of a retrospective analysis summarizing pathology findings in control monkeys
  4. Lauren Mihalcik, Media:Best Practices for HCD in rodent carc studies.pdf, a survey of how different organizations use HCD and recommendations for best practices.
  5. Jen Feldmann, Media:ToxPath- The Value of Historical Control Data.pdf, The value of historical control data-scientific advantages for pathologists, industry and agencies.
  6. Nancy Everds, Media:ASCVP Best Practices for Reference Intervals.pdf, Best practices for reference intervals issued by the American Society of Veterinary Clinical Pathology
  7. Nancy Everds, Media:Amaratunga.pdf, a review of reference intervals for tox studies
  8. Nancy Everds, Media:CLSI.pdf, a guideline for clinical reference interval generation
  9. Example: Judy Henck, [[1]], The Value of Historical Control Data--Scientific Advantages for Pathologists, Industry and Agencies

information about working definitions

Notes from our discussions:

  • reference data from control animals from various studies and animals that have not yet received treatment
  • issue of stock animals not being included in HC because their health status is unknown
  • do sentinel animals contribute to historical controls?
  • control data: statistics vs. individual animal results . Our definition will be for individual animal results.
  • issue of multiple data points for a given animal on a single endpoint (e.g., over time) - so multiple records for an outlier animal don't skew the HC database (alternatively could save data by age)
  • level of analysis for EFD studies: individual animal data contributes to litter data, which is the major basis of analysis

Consensus definition

Historical control data: Test results and observations from individual subjects not treated with test article with known health status (such as control subjects) with descriptive data that adequately characterizes the subject and the conditions under which the data was collected. Data are usually evaluated, curated, and summarized so that the data can be more easily compared with results from other populations.