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Email from Stefen

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In a new trial, the secretion of cytokines by immune cells is measured in a mixture of likely serum and culture medium. The procedure is like this: Blood is drawn and is then incubated for 24 hours in that medium. Substances that are supposed to provoke an immune reaction are added, such as specific antibodies or the study drug. After 24 hours, the cells are removed and the supernatant is collected and analyzed for cytokines such as Interferon gamma and Interleukins.

The secretion is provoked by a Stimulating Agent (Test Condition) and we know what substance was used (Test Condition Agent). However, now comes the tricky part: the study drug should be added to that test tube in different concentrations in order to assess if there are differences in the reaction of the immune cells (T cells and NK cells) secreting Interferon and Interleukins.

So the question is: How would you capture these different concentrations of the Test Condition Agent? Would you recommend to have separate codes in the Test Condition Agent for, let’s say, “Study drug, concentration A”, “Study drug, concentration B”, … and then set up different analytes, one per concentration? Would you use a supplemental qualifier? Or would there be a further option you would recommend we have not yet considered?