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Relevant bibliographies by topics / Surrogate endpoints

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Academic literature on the topic 'Surrogate endpoints'

Author: Grafiati

Published: 4 June 2021

Last updated: 8 February 2022

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Journal articles on the topic "Surrogate endpoints"

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Banerjee, Buddhananda, and Atanu Biswas. "True endpoint reduction by surrogate endpoints." Communications in Statistics - Simulation and Computation 46, no. 8 (May 27, 2016): 6645–53. http://dx.doi.org/10.1080/03610918.2016.1171350.

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Ciani, Oriana, Bogdan Grigore, Hedwig Blommestein, Saskia de Groot, Meilin Möllenkamp, Stefan Rabbe, Rita Daubner-Bendes, and Rod S. Taylor. "Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies." Medical Decision Making 41, no. 4 (March 10, 2021): 439–52. http://dx.doi.org/10.1177/0272989x21994553.

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Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. W

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Ciani, Oriana, Sarah Davis, Paul Tappenden, Ruth Garside, Ken Stein, Anna Cantrell, Everardo D. Saad, Marc Buyse, and Rod S. Taylor. "VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS." International Journal of Technology Assessment in Health Care 30, no. 3 (July 2014): 312–24. http://dx.doi.org/10.1017/s0266462314000300.

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Objectives: Licensing of, and coverage decisions on, new therapies should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may not only expedite the regulatory approval of new therapies but also inform coverage decisions. It is, therefore, essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how the evidence thus derived should be applied by policy makers.Methods: We review current statistical ap

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Ellenberg, SS. "Surrogate endpoints." British Journal of Cancer 68, no. 3 (September 1993): 457–59. http://dx.doi.org/10.1038/bjc.1993.369.

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Hughes, Michael D. "Evaluating surrogate endpoints." Controlled Clinical Trials 23, no. 6 (December 2002): 703–7. http://dx.doi.org/10.1016/s0197-2456(02)00264-7.

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Hahn, Andreas, Andreas Podbielski, Markus M. Heimesaat, Hagen Frickmann, and Philipp Warnke. "Binary surrogate endpoints in clinical trials from the perspective of case definitions." European Journal of Microbiology and Immunology 11, no. 1 (March 30, 2021): 18–22. http://dx.doi.org/10.1556/1886.2020.00031.

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AbstractIntroductionSurrogate endpoints are widely used in clinical trials, especially in situations where the endpoint of interest is not directly observable or to avoid long trial periods. A typical example for this case is frequently found in clinical trials in oncology, where overall survival (OS) as endpoint of interest and progression free survival (PFS) as surrogate endpoint are discriminated.MethodsBased on the perspective of case definitions on surrogate endpoints, we provide a formal definition of such endpoints followed by a description of the structure of surrogate endpoints.Result

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Kuller, Lewis H. "Clinical trials: surrogate endpoints or hard endpoints?" American Journal of Cardiology 88, no. 2 (July 2001): 59–61. http://dx.doi.org/10.1016/s0002-9149(01)01786-6.

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&NA;. "Biomarkers and Surrogate Endpoints." American Journal of Therapeutics 6, no. 4 (July 1999): 179–80. http://dx.doi.org/10.1097/00045391-199907000-00001.

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Somberg, J. "Biomarker and Surrogate Endpoints." American Journal of Therapeutics 10, no. 4 (July 2003): 239–40. http://dx.doi.org/10.1097/00045391-200307000-00001.

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Furgerson, James L., William N. Hannah, and Jennifer C. Thompson. "Challenge of Surrogate Endpoints." Southern Medical Journal 105, no. 3 (March 2012): 156–60. http://dx.doi.org/10.1097/smj.0b013e318249891e.

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Dissertations / Theses on the topic "Surrogate endpoints"

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Feng, Chunyao Seaman John Weldon. "Bayesian evaluation of surrogate endpoints." Waco, Tex. : Baylor University, 2006. http://hdl.handle.net/2104/4187.

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Nordman, Ina IC Clinical School St Vincent's Hospital Faculty of Medicine UNSW. "Surrogate endpoints of survival in metastatic carcinoma." Publisher:University of New South Wales. Clinical School - St Vincent's Hospital, 2008. http://handle.unsw.edu.au/1959.4/42791.

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In most randomised controlled trials (RCTs), a large number of patients need to be followed over many years, for the clinical benefit of the drug to be accurately quantified (1). Using an early proxy, or a surrogate endpoint, in place of the direct endpoint of overall survival (OS) could theoretically shorten the duration of RCTs and minimise the exposure of patients to ineffective or toxic treatments (2, 3). This thesis examined the relationship between surrogate endpoints and OS in metastatic colorectal cancer (CRC), advanced non-small cell lung cancer (NSCLC) and metastatic breast cancer (M

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Wang, Hui. "Response Adaptive Randomization using Surrogate and Primary Endpoints." VCU Scholars Compass, 2016. http://scholarscompass.vcu.edu/etd/4517.

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In recent years, adaptive designs in clinical trials have been attractive due to their efficiency and flexibility. Response adaptive randomization procedures in phase II or III clinical trials are proposed to appeal ethical concerns by skewing the probability of patient assignments based on the responses obtained thus far, so that more patients will be assigned to a superior treatment group. General response-adaptive randomizations usually assume that the primary endpoint can be obtained quickly after the treatment. However, in real clinical trials, the primary outcome is delayed, making it un

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Bark, Charles. "CLINICAL SYMPTOMS AND MICROBIOLOGICAL OUTCOMES IN TUBERCULOSIS TREATMENT TRIALS." Case Western Reserve University School of Graduate Studies / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=case1307630776.

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Dimier, Natalie. "Statistical methodology for evaluation of time-to-event surrogate and true endpoints in small-sample meta-analysis of clinical trials." Thesis, University of Reading, 2017. http://centaur.reading.ac.uk/78463/.

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Clinical trials can be lengthy and costly, with new treatments taking more than a decade to become available to the patients who need them. It is therefore of great interest to improve efficiency in this process, such as replacing the primary endpoint of a clinical trial with an alternative endpoint that can be measured with greater ease, reduced cost or reduced observation periods. Such replacement endpoints are called surrogate endpoints, and there has been a vast amount of research conducted to establish statistical methodology that can reliably assess whether such endpoints are appropriate

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Savina, Marion. "Critères de Substitution à la Survie Globale dans les Essais Cliniques Randomisés en Cancérologie." Thesis, Bordeaux, 2017. http://www.theses.fr/2017BORD0894/document.

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Dans les essais cliniques randomisés (ECR) en cancérologie, un critère de substitution est une mesure biologique utilisée à la place d’un critère cliniquement pertinent pour le patient, par exemple la survie globale (SG), qui doit permettre de prédire l’effet attendu du traitement. Des critères alternatifs à la SG, par exemple la survie sans progression, sont de plus en plus fréquemment utilisés en tant que critère de jugement principal dans les ECR. En pratique cependant, les capacités de substitution à la SG de ces critères ne sont pas systématiquement évaluées. Nous avons dressé un état des

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Branchoux, Sébastien. "Critères de substitution de la survie globale chez les patients atteints de cancer métastatique traités par inhibiteurs de points de contrôle immunologiques." Thesis, Bordeaux, 2020. http://www.theses.fr/2020BORD0253.

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La prise en charge du cancer au stade avancé ou métastatique a été profondément modifiée avec l’arrivée des inhibiteurs des points de contrôle immunologiques (immune-checkpoint inhibitors (ICI)). Ces anticorps monoclonaux immuno-modulateurs ont été développés pour soit déclencher une nouvelle réponse immunitaire anti-tumorale, soit réactiver une réponse existante pour lutter contre le cancer. L’espérance de vie des patients traités par ce type de thérapie est plus longue par rapport à ceux traités par les thérapies usuelles. Par conséquent, la puissance statistique requise dans un essai cliniq

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Sofeu, Casimir. "Développement de méthodes pour la validation de critères de substitution en survie : méta-analyses de cancer." Thesis, Bordeaux, 2019. http://www.theses.fr/2019BORD0383.

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Les critères de substitution peuvent être utilisés à la place du critère de jugement le plus pertinent pour évaluer l'efficacité d'un nouveau traitement. Dans un contexte de méta-analyse, l'approche classique pour la validation d'un critère de substitution est basée sur une stratégie d'analyse en deux étapes. Pour des critères de jugement à temps d’évènements, cette approche est souvent sujette à des problèmes d'estimations. Nous proposons une approche de validation en une étape s'appuyant sur des modèles conjoints à fragilités et à copules. Ces modèles incluent à la fois des effets aléatoires

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Qin, Lang. "Magnetic resonance imaging lesion count as a surrogate endpoint in relapsing-remitting multiple sclerosis clinical trials." Thesis, University of British Columbia, 2011. http://hdl.handle.net/2429/37092.

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The count of active lesions based on magnetic resonance imaging (MRI) is often used as a potential surrogate endpoint in phase 2 clinical trials for relapsing-remitting multiple sclerosis (RRMS) patients. However, this surrogacy relationship has not been completely validated. In this report, we study whether at the trial level, the MRI lesion count is a good surrogate endpoint for the relapse rate, the usual clinical endpoint for RRMS clinical trials. Two different approaches to assess this surrogacy relationship are applied to the dataset used by Sormani et al. [1] (SBRCMB) which contains th

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Munoz, Daniel. "The Effects of Fruit and Vegetable Extracts on Surrogate Endpoint Biomarkers in Curatively Treated Head and Neck Squamous Cell Carcinoma Patients." Scholarly Repository, 2009. http://scholarlyrepository.miami.edu/oa_theses/186.

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Dietary factors have been implicated in the risk of head and neck squamous cell carcinoma (HNSCC). Much interest has been placed upon the effects of suspected chemopreventative agents found in fruit and vegetables associated with low HNSCC risk. However, studies investigating specific uptake of these agents have failed to show positive results. The possibility exists that single chemopreventative agents fail to provide the same beneficial effect as the various compounds found in a fruits and vegetables is examined. Curatively treated head and neck squamous cell carcinoma patients ingested Juic

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Books on the topic "Surrogate endpoints"

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Burzykowski, Tomasz, Geert Molenberghs, and Marc Buyse, eds. The Evaluation of Surrogate Endpoints. New York, NY: Springer New York, 2005. http://dx.doi.org/10.1007/b138566.

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Medicine), Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of. Surrogate endpoints in evaluating the effectiveness of drugs against HIV infection and AIDS: September 11-12, 1989 : conference summary. Washington, D.C: National Academy Press, 1990.

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Morganroth, Joel, and E. Neil Moore, eds. Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia. Boston, MA: Springer US, 1990. http://dx.doi.org/10.1007/978-1-4613-1505-6.

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Alonso, Ariel. Applied Surrogate Endpoint Evaluation Methods with SAS and R. Boca Raton : CRC Press, 2017.: Chapman and Hall/CRC, 2016. http://dx.doi.org/10.1201/9781315372662.

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Institute of Medicine (U.S.). Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Institute of Medicine (U.S.). Board on Health Care Services, Institute of Medicine (U.S.). Board on Health Sciences Policy, Institute of Medicine (U.S.). Food and Nutrition Board, and National Academies Press (U.S.), eds. Perspectives on biomarker and surrogate endpoint evaluation: Discussion forum summary. Washington, D.C: National Academies Press, 2011.

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Symposium on New Drugs and Devices (10th 1989 Philadelphia, Pa.). Use and approval of antihypertensive agents and surrogate endpoints for the approval of drugs affecting antiarrhythmic heart failure and hypolipidemia: Proceedings of the Tenth Annual Symposium on New Drugs & Devices, October 31-November 1, 1989. Boston: Kluwer Academic Publishers, 1990.

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Kim, Sang-gyŏm. Saenghwahakchŏk pʻyojija mit taeri kyŏlgwa pyŏnsu ŭi PK/PD modelling chŏgyong e kwanhan yŏnʼgu =: The study for evaluation of PK/PD modeling using biomarker and surrogate endpoint. [Seoul]: Sikpʻum Ŭiyakpʻum Anjŏnchʻŏng, 2007.

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The Evaluation Of Surrogate Endpoints. Springer, 2010.

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Molenberghs, Geert, Marc Buyse, and Tomasz Burzykowski. The Evaluation of Surrogate Endpoints. Springer, 2009.

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10

Wagner, J. A. Surrogate Endpoints in Medicine (Disease Markers). Ios Pr Inc, 2002.

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Book chapters on the topic "Surrogate endpoints"

1

Ekhtiari, Seper, Ryan P. Coughlin, Nicole Simunovic, and Olufemi R. Ayeni. "Surrogate Endpoints." In Evidence-Based Surgery, 85–92. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-05120-4_9.

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Fleming, Thomas R., Victor DeGruttola, and David L. Demets. "Surrogate Endpoints." In Methods and Applications of Statistics in Clinical Trials, 878–86. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2014. http://dx.doi.org/10.1002/9781118596005.ch74.

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Cleophas, Ton J., and Aeilko H. Zwinderman. "Validating Surrogate Endpoints." In Machine Learning in Medicine, 53–64. Dordrecht: Springer Netherlands, 2013. http://dx.doi.org/10.1007/978-94-007-6886-4_7.

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Molenberghs, Geert, Ziv Shkedy, Burzykowski Tomasz, Marc Buyse, Ariel Alonso Abad, and Wim Van der Elst. "Evaluation of Surrogate Endpoints." In Handbook of Statistical Methods for Randomized Controlled Trials, 567–600. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315119694-26.

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Ciccone, Giovannino, and Ileana Baldi. "Surrogate Endpoints of Clinical Benefit." In Imaging Tumor Response to Therapy, 3–14. Milano: Springer Milan, 2012. http://dx.doi.org/10.1007/978-88-470-2613-1_1.

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Shkedy, Ziv, and Franz Torres Barbosa. "Bayesian Evaluation of Surrogate Endpoints." In Statistics for Biology and Health, 253–70. New York, NY: Springer New York, 2005. http://dx.doi.org/10.1007/0-387-27080-9_15.

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Paoletti, Xavier, Federico Rotolo, and Stefan Michiels. "Assessing the Value of Surrogate Endpoints." In Textbook of Clinical Trials in Oncology, 425–46. Boca Raton, Florida : CRC Press, [2019]: Chapman and Hall/CRC, 2019. http://dx.doi.org/10.1201/9781315112084-20.

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George, Stephen L. "Surrogate Endpoints in Cancer Clinical Trials." In Statistical Models in Epidemiology, the Environment, and Clinical Trials, 251–72. New York, NY: Springer New York, 2000. http://dx.doi.org/10.1007/978-1-4612-1284-3_8.

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Cleophas, Ton J., and Aeilko H. Zwinderman. "Validating Surrogate Endpoints of Clinical Trials." In Statistics Applied to Clinical Studies, 569–78. Dordrecht: Springer Netherlands, 2011. http://dx.doi.org/10.1007/978-94-007-2863-9_52.

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Passiglia, Francesco, Giuseppe Cicero, Marta Castiglia, and Viviana Bazan. "Biomarkers as Prognostic, Predictive, and Surrogate Endpoints." In Current Clinical Pathology, 31–41. New York, NY: Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2047-1_4.

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Conference papers on the topic "Surrogate endpoints"

1

Coxson, Harvey O., Michael L. Watkins, Nicholas W. Locantore, Peter M. Calverley, Bartolome Celli, and Victor M. Pinto-Plata. "Computed Tomography And Associations To Lung Mechanics The Evaluation Of COPD Longitudinally To Identify Predictive Surrogate Endpoints (ECLIPSE) Study." In American Thoracic Society 2010 International Conference, May 14-19, 2010 • New Orleans. American Thoracic Society, 2010. http://dx.doi.org/10.1164/ajrccm-conference.2010.181.1_meetingabstracts.a5136.

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Coxson, HO, HA Gietema, PS Bakke, SS Sharma, and LD Edwards. "Contributions of Airway Wall Thickening and Emphysema to Airflow Limitation: ”Evaluation of COPD Longitudinally To Identify Predictive Surrogate Endpoints” (ECLIPSE) Study." In American Thoracic Society 2009 International Conference, May 15-20, 2009 • San Diego, California. American Thoracic Society, 2009. http://dx.doi.org/10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a6200.

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Anzueto, A., JA Wedzicha, JR Hurst, J. Vestbo, J. Yates, R. Tal-Singer, and DP Miller. "Diagnosis of COPD Exacerbations and Their Distribution Based on GOLD Severity Stages. Data from the Evaluation of COPD Longitudinally To Identify Predictive Surrogate Endpoints (ECLIPSE) Study." In American Thoracic Society 2009 International Conference, May 15-20, 2009 • San Diego, California. American Thoracic Society, 2009. http://dx.doi.org/10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a1527.

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Coxson, Harvey O., Lisa Edwards, Per Bakke, Edwin K. Silverman, William MacNee, and &. ECLIPSE Investigators. "Relationship Between Lung Volumes And The Extent Of Emphysema As Assessed By Computed Tomography In The "Evaluation Of COPD Longitudinally To Identify Predictive Surrogate Endpoints" (ECLIPSE) Study." In American Thoracic Society 2011 International Conference, May 13-18, 2011 • Denver Colorado. American Thoracic Society, 2011. http://dx.doi.org/10.1164/ajrccm-conference.2011.183.1_meetingabstracts.a5781.

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Maselli, Diego J., Hana Müllerova, Nicholas W. Locantore, Jorgen Vestbo, John R. Hurst, Jadwiga A. Wedzicha, and Antonio Anzueto. "Risk Factors And Mortality Associated With Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Exacerbations During The 3-Year Follow-Up In The Evaluation Of COPD Longitudinally To Identify Predictive Surrogate Endpoints (Eclipse) Cohort." In American Thoracic Society 2011 International Conference, May 13-18, 2011 • Denver Colorado. American Thoracic Society, 2011. http://dx.doi.org/10.1164/ajrccm-conference.2011.183.1_meetingabstracts.a5374.

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Fuhlbrigge, A. L., T. W. Harrison, M. Fagerås, A. Jauhiainen, L. E. J. M. Scheepers, J. Zangrilli, and C. A. Da Silva. "An Investigation of Geographic Influence on CompEx, a Surrogate Endpoint for Severe Asthma Exacerbations." In American Thoracic Society 2019 International Conference, May 17-22, 2019 - Dallas, TX. American Thoracic Society, 2019. http://dx.doi.org/10.1164/ajrccm-conference.2019.199.1_meetingabstracts.a1298.

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Heckman-Stoddard, B., RA Lubet, AM Bode, and CJ Grubbs. "P3-11-07: Mammary Gland Biopsy To Examine Surrogate Endpoint Biomarkers of Preventive Agent Efficacy." In Abstracts: Thirty-Fourth Annual CTRC‐AACR San Antonio Breast Cancer Symposium‐‐ Dec 6‐10, 2011; San Antonio, TX. American Association for Cancer Research, 2011. http://dx.doi.org/10.1158/0008-5472.sabcs11-p3-11-07.

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Gabler, Nicole B., Benjamin French, Brian L. Strom, Harold I. Palevsky, Darren Taichman, Steven M. Kawut, and Scott D. Halpern. "Validation Of Six-Minute-Walk Distance As A Surrogate Endpoint In Pulmonary Arterial Hypertension Trials." In American Thoracic Society 2012 International Conference, May 18-23, 2012 • San Francisco, California. American Thoracic Society, 2012. http://dx.doi.org/10.1164/ajrccm-conference.2012.185.1_meetingabstracts.a4092.

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Harris, Wayne B., Dana C. Nickleach, Yuan Liu, Omer Kucuk, and Viraj A. Master. "Abstract C15: Inflammation-free survival as a surrogate endpoint for overall survival in patients with metastatic renal cell carcinoma." In Abstracts: Sixth AACR Conference: The Science of Cancer Health Disparities; December 6–9, 2013; Atlanta, GA. American Association for Cancer Research, 2014. http://dx.doi.org/10.1158/1538-7755.disp13-c15.

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Stamp, L., M. Morillon, W. Taylor, N. Dalbeth, J. Singh, and R. Christensen. "OP0267 Serum urate as a surrogate endpoint for gout flares: results of a systematic review and meta-regression analysis of randomized trials." In Annual European Congress of Rheumatology, 14–17 June, 2017. BMJ Publishing Group Ltd and European League Against Rheumatism, 2017. http://dx.doi.org/10.1136/annrheumdis-2017-eular.1544.

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