High-Value Cancer Care and the Problem With Surrogate Endpoints in the Quality/Cost Equation

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Fumiko Chino
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  • 1.

    Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American Society of Clinical Oncology Value Framework: revisions and reflections in response to comments received. J Clin Oncol 2016;34:29252934.

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  • 2.

    Cheng S, Cheung MC, Jiang DM, et al. Are surrogate endpoints unbiased metrics in clinical benefit scores of the ASCO Value Framework? J Natl Compr Canc Netw 2019;17:1489–1496.

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  • 3.

    Kim C, Prasad V. Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: an analysis of 5 years of US Food and Drug Administration approvals. JAMA Intern Med 2015;175:19921994.

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  • 4.

    Chen EY, Raghunathan V, Prasad V. An overview of cancer drugs approved by the US Food and Drug Administration based on the surrogate end point of response rate. JAMA Intern Med 2019;179:915921.

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  • 5.

    Chen EY, Joshi SK, Tran A, Prasad V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical trials. JAMA Intern Med 2019;179:642647.

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  • 6.

    Haslam A, Hey SP, Gill J, Prasad V. A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology. Eur J Cancer 2019;106:196211.

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  • 7.

    Kay A, Higgins J, Day AG, et al. Randomized controlled trials in the era of molecular oncology: methodology, biomarkers, and end points. Ann Oncol 2012;23:16461651.

  • 8.

    Saluja R, Everest L, Cheng S, et al. Assessment of whether the American Society of Clinical Oncology's Value Framework and the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale measure absolute or relative clinical survival benefit: a meta-analysis of randomized clinical trials [published online May 16, 2019]. JAMA Oncol. doi: 10.1001/jamaoncol.2019.0818

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  • 9.

    Seymour EK, Schiffer CA, de Souza JA. Challenges in the clinical application of the American Society of Clinical Oncology Value Framework: a Medicare cost-benefit analysis in chronic lymphocytic leukemia. J Oncol Pract 2017;13:e10021011.

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  • 10.

    Saad ED, Buyse M. Statistical controversies in clinical research: end points other than overall survival are vital for regulatory approval of anticancer agents. Ann Oncol 2016;27:373378.

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