Peer review of the Glucocorticoid Receptor Transactivation method validation

The project for the development of a Test Guideline on a Stably transfected human glucocorticoid receptor (hGR) transcriptional activation assay for detection of agonistic and antagonist activity of chemicals towards hGR, was included in the OECD Test Guideline Programme workplan in 2023, on a proposal from France and Canada.

The assay underwent several steps of validation studies. The results have been consolidated into a validation report, now subject to evaluation by an independent panel of peer reviewers. See below the documents for review.

Two documents are released for public consultation:

• Validation report on the Glucocorticoid receptor transactivation method

• Glucocorticoid receptor transactivation method – Phase 2 validation data Excel file. 
  This file exclusively covers the blinded Phase 2. The blinded study is the key part of the GRTA validation and is discussed in terms of reproducibility. Data from the two other phases are available in separate Excel files and can be obtained from the Secretariat. The spreadsheet includes multiple sheets, with the first one providing an overview and brief explanations from the data manager.
  Each sheet represents steps from import/reporting of data from the labs to the generation of dose-response curves and exportable data.
  Those interested can follow the steps, but it is crucial to understand the “Substance” sheet. In this sheet, it is possible to choose the data to be plotted using the 4 separate filters. Mode, Lab, Substance and Control status (valid vs invalid). Here it is possible to look at the dose-responses for one or more compounds, one or more labs, modes, and status.
  The selected choices will update the graph, displaying above the chosen studies with data for concentration and normalized responses.
  One tab also contains the de-coding of the substance enabling to select a substance knowing its number before the de-coding.
  These types of data are also available in the export sheet, allowing for export to R or Prism, for example.

It is expected that only an established peer review panel would contribute to the peer review of the assay. However, should the public wish to provide comments, please contact the OECD Secretariat at: nathalie.delrue@oecd.org.