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. Author manuscript; available in PMC: 2023 Mar 1.
Published in final edited form as: Nat Med. 2022 Mar;28(3):430–432. doi: 10.1038/s41591-021-01652-8

Fig. 1 ∣. The FNIH NIMBLE project plan.

Fig. 1 ∣

The biomarker qualification process was initiated by approval of the letter of intent submitted by the NIMBLE consortium to the FDA. This will be complemented by cross-sectional studies of circulating biomarkers and methodological studies of MRI and ultrasound-based biomarkers in stage 1. After completion of stage 1, a full biomarker qualification plan will be submitted for review by the FDA. The results of stage 1 will also trigger stage 2, which will include a prospective evaluation of selected biomarkers for final and full qualification combining data from both stage 1 and stage 2.