Charting a Roadmap for Heart Failure Biomarker Studies
The following are 10 points to remember about heart failure biomarker studies:
1. The authors of this state-of-the-art paper, who are thought to be leaders in the field of heart failure and biomarkers, propose a systematized approach to studying the utility of biomarkers.
2. This paper focuses on the four main clinical uses of biomarkers, namely: a) diagnosis, b) risk stratification, c) guidance in selection or titration of therapy, and d) screening for preclinical use.
3. They propose an approach that is based on adherence to specific quality measures with a view of augmenting the utility of current prediction models or utilizing biomarkers to guide therapy.
4. They emphasize that study quality rather than results be used to determine publication, and propose a system for grading biomarker studies using the Paris criteria.
5. They propose an interaction between statisticians and clinical investigators to allow introduction of more robust statistical methodologies so that a larger number of variables can be distilled to information that is relevant clinically.
6. They also propose establishment of a consortium that would analyze pooled samples of clinical trials, generate hypothesis for evaluating biomarker-guided clinical trials, undertake meta-analysis of completed trials, and spearhead clinical trials to test clinical utility of biomarkers in heart failure.
7. To evaluate the biomarkers for treatment guidance, they propose a combination of three commonly used approaches, including: a) biomarker-stratified designs, b) enrichment designs, and c) biomarker strategy designs. Relative merits of these approaches with clear examples are included in this paper.
8. They propose that the consortium should use hypothesis-driven treatment interaction testing of ‘first-tier’ biomarkers (i.e., those biomarkers with the most convincing data in support of potential value).
9. They discuss the pros and cons of a multimarker approach so that testing of multiple biomarkers is appropriately validated.
10. This paper discusses unanswered questions pertaining to heart failure biomarkers and recommends of roadmap for future studies.
The authors of this paper have to be commended for their clarion call regarding future research on heart failure biomarkers. Pooling resources worldwide should provide better data than what are currently available. This roadmap should prevent the current ‘scattershot’ approach to evaluating biomarkers, and should enhance the quality and efficacy of clinical care by helping with triage and risk stratification. In particular, this roadmap should allow development of a biomarker strategy that would result in cost reduction of medical care by leading to an early initiation of highly effective treatment strategies that reduce the risk of complications of the disease process, by reducing the need for other expensive diagnostic tests or by establishing an alternative diagnosis that does not require hospitalization.
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