Statistical Considerations for Planning Clinical Trials with Quantitative Imaging Biomarkers

• Published in: JNCI : Journal of the National Cancer Institute Vol. 111; no. 1; pp. 19 - 26
• Main Authors: Obuchowski, Nancy A, Mozley, P David, Matthews, Dawn, Buckler, Andrew, Bullen, Jennifer, Jackson, Edward
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 01.01.2019; Oxford Publishing Limited (England)
• Subjects: Biomarkers; Biomarkers - analysis; Clinical trials; Clinical Trials as Topic - standards; Computer simulation; Diagnostic Imaging - methods; Drug development; Error analysis; Humans; Imaging; Monte Carlo simulation; Neoplasms - diagnosis; Neoplasms - therapy; Outcome Assessment, Health Care; Research Design - statistics & numerical data; Standardization

Abstract As imaging technologies and treatment options continue to advance, imaging outcome measures are becoming increasingly utilized as the basis of making major decisions in new drug development and clinical practice. Quantitative imaging biomarkers (QIBs) are now commonly used for subject selec...