OMB Meeting Book - January 8, 2015

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Table 1. Comparison of Collaborative and PT Studies Property Collaborative

PT

Measure method variance components and recovery bias, and to show equivalency to a reference method or meet performance requirements

Measure collaborator result compared to others

Purpose

Controlled Randomized

Variants possible

Method procedure

Randomize

Test portions

Full range of interest

Single level, nominal

Levels of concentration of analyte

Multiple

Single

Matrices

Full

Simple result

Disclosure

Controlled Controlled Controlled Controlled

Ad hoc Ad hoc

Collaborator reporting Experimental design Reproducibility conditions Repeatability conditions

May vary May vary

Cross-sectional

Learning curve Low to moderate

Time element

High

Cost

Infrequent Usually clear

Common Quizzical

Suspicious data Interpretability

Here we propose that the optimal solution to this issue is to divide a traditional collaborative into separate incremental experiments (‘modules’) that preserve the randomization and control of the planned collaborative study, but reduce the involvement and deployment load to that of a PT study. Such an incremental collaborative study (as opposed to a cross-sectional collaborative study) would have all of the advantages of the traditional collaborative study and of the PT study, with none of the disadvantages of either.

4

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Recommended to OMB by Committee on Statistics: 07-17-2013 Reviewed and approved by OMB: 07-18-2013