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How do you design a comparison study?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

For comparison study design and analysis to establish performance characteristics related to the accuracy of the candidate test, there are these appropriate FDA-recognized consensus standards:

  • For quantitative tests: Clinical Laboratory Standards Institute (CLSI) EP21, CLSI EP27
  • For qualitative tests: CLSI EP12

These standards include discussion of the importance of selecting an appropriate comparative method (CM) and describe quality hierarchies of preferred CM types for quantitative and binary qualitative tests. Comparison to higher quality CMs (e.g. reference methods or methods traceable to higher order references), when available, provides more absolute information about the accuracy of the candidate test while comparison to lower quality CMs may provide only relative performance information. Where there is no generally accepted CM for an IVD device type, the use of a legally marketed predicate device or other well-documented method as the CM would generally be appropriate. FDA recommends discussing the selection of an appropriate CM as part of a Pre-Submission prior to conducting the comparison study.

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