Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (2010) / Chapter Skim
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Appendix A: Table of Papers About Biomarker Qualification
Appendix A: Table of Papers About Biomarker Qualification
Pages 253-278
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Appendix A Table of Papers About Biomarker Qualification
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1978 Baker Nomenclature: Oncology Third report of Preoperative assessment of the biomarker patient with breast cancer. 1980 Regelson Nomenclature: General Medicine First report Biomarkers in aging: A beginning of biomarker for a therapeutic approach in outside cancer Transactions of the Association of in medicine Life Insurance Medical Directors of America.
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Biomarkers Oncology for clinical Feasibility study in the application development of 17 biological markers for ovarian cancer. 1983 Wood Nomenclature: Rheumatology First report Nature of surrogate endpoints.
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worse Herson First substantive Methodology discussion An introduction to four invited on surrogate papers on surrogate endpoints in endpoints in clinical trials. These were pivotal clinical trials papers.
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1990 Machado et al. Testing validity HIV Medicine of surrogate Pros for surrogate endpoints: therapeutics Ethical/practical reasons for hastening decision making about the efficacy of new treatments for HIV infection.
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Other fields in medicine did not have resources to conduct large, long studies and continued to argue for the use of surrogates in drug development.) Lippman et al.
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Proviso 2, that relationship between the surrogate and clinical endpoint, is well established through relevant epidemiological studies. Proviso 3, that the estimate of the expected clinical benefit should be derivable from the estimate of the reduction on the surrogate endpoint, which can be obtained from randomized clinical trials data.
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Hughes et al. Review Statistics/HIV Evaluating surrogate markers.
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Lin et al. Statistics Statistics Estimating the proportion of a treatment effect explained by surrogate marker.
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Rolan Schema Methodology The contribution of clinical pharmacology surrogates and models to drug development. Proposes five dimensional properties of surrogates.
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Statistics Statistics Statistical validation of surrogate endpoints. Colburn Schema Methodology Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for efficient drug development.
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Conclusion: Meta-analysis of surrogate endpoints may lead to less precise estimates of treatment effect on clinical endpoint than relying on clinical endpoint itself. Begg and Leung Statistics Statistics Provide conceptual alternatives to Prentice criterion for surrogate statistical validation.
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2002 Wang and Statistics Statistics Taylor A measure of the proportion of treatment effect explained by a surrogate marker. Lathia Review Methodology Biomarkers and surrogate endpoints: How and when might they impact drug development?
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Berger Statistics Statistics Does Prentice criterion validate surrogate endpoints? Molenberghs Statistics Methodology et al.
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Finley Austin Review Methodology and Babiss Where and how could biomarkers be used in 2016? Qu and Case Statistics Statistics Quantifying the indirect treatment effect via surrogate markers.
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58942–58960. AA = adjusted association; AIDS = acquired immune deficiency syndrome; b-HCG = beta-human chorionic gonadotropin; CAST = The Cardiac Arrhythmia Suppression Trial; CEA = carcinoembryonic antigen; FDA = Food and Drug Administration; HIV = human immunodeficiency virus; HOT = The Hypertension Optimal Treatment Study; HTLV-III = human T-lymphotropic virus type III; LDH = lactate dehydrogenase; NIH = National Institutes of Health; PTE = proportion of treatment effect; RCT = randomized controlled trial; RE = relative effect; TPA = tissue plasminogen activator.
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Regulatory Nutrition Discussion of emerging surrogate endpoints and the use of surrogate endpoints in the review of health claims at the FDA. 2008 Alonso and Statistics Methodology/Oncology Molenberghs Evaluation of time to cancer recurrence as a surrogate endpoint for survival, as evaluated using a meta-analytic framework.
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Psaty and Comment Cardiology Lumley Further discussion of recent surrogate endpoint failures in lipid altering drug clinical trials. Wagner Schema Methodology Comprehensive discussion of fit for-purpose biomarker qualification for all stages of drug development.
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1998. Statistical issues for HIV surrogate endpoints: Point/counterpoint.
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2000. Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development.
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1989. The use of surrogate endpoints in clinical trials (an introduction to a series of four papers)
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2002. Biomarkers and surrogate endpoints: How and when might they impact drug development?
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2007. Information-theory based surrogate marker evaluation from several randomized clinical trials with continuous true and binary surrogate endpoints.
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2009. Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials.
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1989. Surrogate endpoints in clinical trials: Cardio vascular diseases.
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