Enabling Real-World Data to Accelerate the Development of Innovative Cancer Biomarkers
Chen Yeh
Enabling Real-World Data to Accelerate the Development of Innovative Cancer Biomarkers
The molecular diagnostics industry has historically relied on sanitized clinical trials and commoditized data sources to inform its biomarker discovery and validation process—an under-substantiated approach that was ultra-expensive, resource-consuming and did not reflect how representative a new biomarker would be in broader patient populations. In an effort to gain more accurate insight into the patient experience and bring innovative biomarkers to market more efficiently and accurately, the industry is now expanding into extended real-world data. To access the needed breadth and depth of patient-centric data, diagnostic companies must collaborate with a healthcare data analytics partner that has three key assets: (i) a broad and deep megadata with metadata, (ii) a data-rich provider network, and (iii) an outcomes-improvement engine to support the next generation of molecular diagnostics (Dx) and therapeutics (Rx) development.
real-world data / cancer / biomarker / Dx / Rx
[1] |
Kosorok MR, Laber EB.Precision medicine. Annu Rev Stat Appl 2019; 6(01) 263-286
|
[2] |
National Research Council (US) Committee on A Framework for Developing a New Taxonomy of Disease. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. National Academies Press (US); 2011
|
[3] |
Cagney DN, Sul J, Huang RY, Ligon KL, Wen PY, Alexander BM.The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology. euro Oncol 2018; 20(09) 1162-1172
|
[4] |
Yeh C.Circulating cell-free transcriptomics in cancer. J Lung Pulm Respir Res 2023; 10(02) 27-29
|
[5] |
Febbo PG, Ladanyi M, Aldape KD.et al. NCCN Task Force report: Evaluating the clinical utility of tumor markers in oncology. J Natl Compr Canc Netw 2011; 9(Suppl. 05) S1-S32, quiz S33
|
[6] |
Marabelle A, Fakih M, Lopez J.et al.Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol 2020; 21(10) 1353-1365
|
[7] |
Ng K, Ogino S, Meyerhardt JA.et al.Relationship between statin use and colon cancer recurrence and survival: results from CALGB 89803. J Natl Cancer Inst 2011; 103(20) 1540-1551
|
/
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