An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles Article Swipe
Robert S. Bresalier
,
Carlo Senore
,
Graeme P. Young
,
James E. Allison
,
Robert Benamouzig
,
Sally C. Benton
,
Patrick M. Bossuyt
,
Luis Caro
,
Beatriz Carvalho
,
Han‐Mo Chiu
,
Veerle M.H. Coupé
,
Willemijn de Klaver
,
Clasine M. de Klerk
,
Evelien Dekker
,
Sunil Dolwani
,
Callum G. Fraser
,
William M. Grady
,
Lydia Guittet
,
Samir Gupta
,
Stephen P Halloran
,
Ulrike Haug
,
Geir Hoff
,
Steven H. Itzkowitz
,
Tim Kortlever
,
Anastasios Koulaouzidis
,
Uri Ladabaum
,
Béatrice Secretan
,
Mārcis Leja
,
Bernard Levin
,
Theodore R. Levin
,
Finlay Macrae
,
Gerrit A. Meijer
,
Joshua Melson
,
Colm O’Morain
,
Susan Parry
,
Linda Rabeneck
,
David F. Ransohoff
,
Roque Sáenz
,
Hiroshi Saito
,
Silvia Sanduleanu‐Dascalescu
,
Robert E. Schoen
,
Kevin Selby
,
Harminder Singh
,
R. Steele
,
Joseph J.�Y. Sung
,
Erin L. Symonds
,
Sidney J. Winawer
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1136/gutjnl-2023-329701
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1136/gutjnl-2023-329701
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 ( phase I ), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia-enriched populations ( phase II ). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. Phase III prospective studies determine single round intention-to-screen programme outcomes and confirm the test positivity threshold. Phase IV studies involve evaluation over repeated screening rounds with monitoring for missed lesions. Phases III and IV findings will provide the real-world data required to model test impact on CRC mortality and incidence. 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.
Related Topics
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/gutjnl-2023-329701
- https://gut.bmj.com/content/gutjnl/early/2023/07/18/gutjnl-2023-329701.full.pdf
- OA Status
- bronze
- Cited By
- 42
- References
- 62
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4384664239
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4384664239Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1136/gutjnl-2023-329701Digital Object Identifier
- Title
-
An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principlesWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-07-18Full publication date if available
- Authors
-
Robert S. Bresalier, Carlo Senore, Graeme P. Young, James E. Allison, Robert Benamouzig, Sally C. Benton, Patrick M. Bossuyt, Luis Caro, Beatriz Carvalho, Han‐Mo Chiu, Veerle M.H. Coupé, Willemijn de Klaver, Clasine M. de Klerk, Evelien Dekker, Sunil Dolwani, Callum G. Fraser, William M. Grady, Lydia Guittet, Samir Gupta, Stephen P Halloran, Ulrike Haug, Geir Hoff, Steven H. Itzkowitz, Tim Kortlever, Anastasios Koulaouzidis, Uri Ladabaum, Béatrice Secretan, Mārcis Leja, Bernard Levin, Theodore R. Levin, Finlay Macrae, Gerrit A. Meijer, Joshua Melson, Colm O’Morain, Susan Parry, Linda Rabeneck, David F. Ransohoff, Roque Sáenz, Hiroshi Saito, Silvia Sanduleanu‐Dascalescu, Robert E. Schoen, Kevin Selby, Harminder Singh, R. Steele, Joseph J.�Y. Sung, Erin L. Symonds, Sidney J. WinawerList of authors in order
- Landing page
-
https://doi.org/10.1136/gutjnl-2023-329701Publisher landing page
- PDF URL
-
https://gut.bmj.com/content/gutjnl/early/2023/07/18/gutjnl-2023-329701.full.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
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https://gut.bmj.com/content/gutjnl/early/2023/07/18/gutjnl-2023-329701.full.pdfDirect OA link when available
- Concepts
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Colorectal cancer, Medicine, Computer science, Cancer, Medical physics, Internal medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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42Total citation count in OpenAlex
- Citations by year (recent)
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2025: 19, 2024: 20, 2023: 3Per-year citation counts (last 5 years)
- References (count)
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62Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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