Publication Date
10-1-2023
Journal
Gut
Abstract
OBJECTIVE: New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers.
DESIGN: A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles.
RESULTS: Twelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four-phased approach is proposed, commencing with small studies assessing the test's ability to discriminate between CRC and non-cancer states (
CONCLUSION: New non-invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact.
Keywords
Humans, Mass Screening, Prospective Studies, Early Detection of Cancer, Colorectal Neoplasms, Colonoscopy, Occult Blood, Feces
Included in
Bioinformatics Commons, Biomedical Informatics Commons, Digestive System Diseases Commons, Gastroenterology Commons, Hepatology Commons, Internal Medicine Commons, Medical Sciences Commons, Oncology Commons
Comments
Supplementary Materials
PMID: 37463757