Biomarker Evaluation and Clinical Development
Most candidate biomarkers are never adopted into clinical practice. The likelihood that a biomarker with good predictive properties will be incorporated into urologic decision-making and will improve patient care can be enhanced by following established principles of biomarker...
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| Format: | Article |
| Language: | English |
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The Société Internationale d’Urologie (SIU)
2020-10-01
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| Series: | Société Internationale d’Urologie Journal |
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| Online Access: | https://siuj.org/index.php/siuj/article/view/43/6 |
| _version_ | 1797370136162729984 |
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| author | Melissa Assel, Andrew Vickers |
| author_facet | Melissa Assel, Andrew Vickers |
| author_sort | Melissa Assel, Andrew Vickers |
| collection | DOAJ |
| description | Most candidate biomarkers are never adopted into clinical practice. The likelihood that a biomarker with good predictive properties will be incorporated into urologic decision-making and will improve patient care can be enhanced by following established principles of biomarker development. Studies should follow the REMARK guidelines, should have clinically relevant outcomes, and should evaluate the biomarker on the same patients to whom the biomarker would be applied in practice. It is also important to recognize that biomarker research is comparative: the question is not whether a biomarker provides information, but whether it provides better information than is already available. Continuous biomarkers should not be categorized above or below a fixed cutpoint: risk prediction allows for individualization of care. The risk predictions must be calibrated, that is, close to a patient’s true risk, and decision analysis is required to determine whether using the biomarker in clinical practice would change decisions and improve outcomes. Finally, impact studies are needed to evaluate how use of the biomarker in the real world affects outcomes. |
| first_indexed | 2024-03-08T17:57:04Z |
| format | Article |
| id | doaj.art-35ba382967c4481b855e2ad41882bfac |
| institution | Directory Open Access Journal |
| issn | 2563-6499 |
| language | English |
| last_indexed | 2024-03-08T17:57:04Z |
| publishDate | 2020-10-01 |
| publisher | The Société Internationale d’Urologie (SIU) |
| record_format | Article |
| series | Société Internationale d’Urologie Journal |
| spelling | doaj.art-35ba382967c4481b855e2ad41882bfac2024-01-02T04:00:50ZengThe Société Internationale d’Urologie (SIU)Société Internationale d’Urologie Journal2563-64992020-10-0111162210.48083//ZCJS3811Biomarker Evaluation and Clinical DevelopmentMelissa Assel, Andrew VickersMost candidate biomarkers are never adopted into clinical practice. The likelihood that a biomarker with good predictive properties will be incorporated into urologic decision-making and will improve patient care can be enhanced by following established principles of biomarker development. Studies should follow the REMARK guidelines, should have clinically relevant outcomes, and should evaluate the biomarker on the same patients to whom the biomarker would be applied in practice. It is also important to recognize that biomarker research is comparative: the question is not whether a biomarker provides information, but whether it provides better information than is already available. Continuous biomarkers should not be categorized above or below a fixed cutpoint: risk prediction allows for individualization of care. The risk predictions must be calibrated, that is, close to a patient’s true risk, and decision analysis is required to determine whether using the biomarker in clinical practice would change decisions and improve outcomes. Finally, impact studies are needed to evaluate how use of the biomarker in the real world affects outcomes.https://siuj.org/index.php/siuj/article/view/43/6biomarkersprediction modelingprostate cancerclinical utilitydecision analysisdiscriminationcalibrationnet benefit |
| spellingShingle | Melissa Assel, Andrew Vickers Biomarker Evaluation and Clinical Development Société Internationale d’Urologie Journal biomarkers prediction modeling prostate cancer clinical utility decision analysis discrimination calibration net benefit |
| title | Biomarker Evaluation and Clinical Development |
| title_full | Biomarker Evaluation and Clinical Development |
| title_fullStr | Biomarker Evaluation and Clinical Development |
| title_full_unstemmed | Biomarker Evaluation and Clinical Development |
| title_short | Biomarker Evaluation and Clinical Development |
| title_sort | biomarker evaluation and clinical development |
| topic | biomarkers prediction modeling prostate cancer clinical utility decision analysis discrimination calibration net benefit |
| url | https://siuj.org/index.php/siuj/article/view/43/6 |
| work_keys_str_mv | AT melissaasselandrewvickers biomarkerevaluationandclinicaldevelopment |