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How to evaluate emerging technologies in cervical cancer screening?
Marc Arbyn1, Guglielmo Ronco, Jack Cuzick
1Unit of Cancer Epidemiology / Belgian Cancer Centre, Scientific Institute of Public Health, Brussels, Belgium. marc.arbyn@iph.fgov.be
Abstract:
Excellent recommendations exist for studying therapeutic and diagnostic questions. We observe that good guidelines on assessment of evidence for screening questions are currently lacking. Guidelines for diagnostic research (STARD), involving systematic application of the reference test (gold standard) to all subjects of large study populations, are not pertinent in situations of screening for disease that is currently not yet present. A five-step framework is proposed for assessing the potential use of a biomarker as a screening tool for cervical cancer: i) correlation studies establishing a trend between the rate of biomarker expression and severity of neoplasia; ii) diagnostic studies in a clinical setting where all women are submitted to verification by the reference standard; iii) biobank-based studies with assessment in archived cytology samples of the biomarker in cervical cancer cases and controls; iv) prospective cohort studies with baseline assessment of the biomarker and monitoring of disease; v) randomised intervention trials aiming to observe reduced incidence of cancer (or its surrogate, severe dysplasia) in the experimental arm at subsequent screening rounds. The 5-phases framework should guide researchers and test developers in planning assessment of new biomarkers and protect clinicians and stakeholders against premature claims for insufficiently evaluated products.
Insights
A new five-step framework is proposed for evaluating cervical cancer screening biomarkers. This framework guides researchers and protects clinicians from premature claims about insufficiently evaluated screening tools.
Area of Science:
- Biomarker discovery and validation
- Cervical cancer screening
- Epidemiological research methods
Background:
- Existing guidelines effectively address therapeutic and diagnostic research questions.
- There is a lack of robust guidelines for assessing evidence related to screening questions.
- Current diagnostic research guidelines (e.g., STARD) are not directly applicable to disease screening.
Purpose of the Study:
- To propose a framework for assessing the utility of biomarkers for cervical cancer screening.
- To provide guidance for researchers and test developers in evaluating new screening tools.
- To safeguard clinicians and stakeholders from premature adoption of inadequately validated biomarkers.
Main Methods:
- A five-phase framework is outlined for biomarker assessment.
- Phase i: Correlation studies on biomarker expression and neoplasia severity.
- Phase ii: Clinical diagnostic studies with reference standard verification.
- Phase iii: Biobank studies using archived samples.
- Phase iv: Prospective cohort studies with baseline biomarker assessment and disease monitoring.
- Phase v: Randomized intervention trials to assess cancer incidence reduction.
Main Results:
- The proposed framework systematically progresses from early-stage correlation studies to late-stage intervention trials.
- Each phase builds upon the previous one, ensuring comprehensive evaluation of biomarker potential.
- The framework is designed to be applicable to cervical cancer screening biomarkers.
Conclusions:
- The five-phase framework offers a structured approach to evaluating cervical cancer screening biomarkers.
- Implementation of this framework will enhance the rigor of biomarker assessment.
- It aims to prevent the premature introduction of unproven screening technologies, thereby improving patient outcomes.
