Integral assays refer to tests that must be performed for the trial to proceed.
Integrated assays include assays that will be performed on all samples or cases (for imaging studies) but are not required for the trial to proceed and will not inform treatment decisions or actions within the current trial.
Clinical trials often include assays and imaging tests as integral or integrated assays. NCI expects these tests to meet certain standards to ensure regulatory compliance and the responsible use of clinical samples—a precious and non-renewable resource—and to allow for rapid clinical translation of the tests.
In general, supporting information for integral assays must include the categories of data that would be required for submission for FDA clearance (510k—substantial equivalence) or approval (premarket application). In vitro assays must be performed in CLIA-certified laboratories at minimum, and in-vivo imaging assays (i.e., imaging tests) must be performed using standardized guidelines for image acquisition, analysis, and interpretation.
Download a copy of the Performance Standards Reporting Requirements for Essential Assays in Clinical Trials document. It includes an appendix describing the information required in protocols that include an integral biomarker assay or imaging study.
Similarly, supporting information for integrated assays must show that the test is well characterized and that the statistical design (hypothesis and sample size) reflects the suitability of the assay’s use in the trial.
NCI provides this resource to help guide development plans, recognizing that it may not always be possible for every assay or imaging test to immediately meet all these standards.